Caries Diagosis

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    Structured Abstract

    Objectives

    Dental caries is a widespread chronic infectious disease, experienced by almost 80

    percent of children by the age of 18 and over 90 percent of adults. Substantial

    variation exists in dentists' diagnoses of carious lesions as well as in the methods

    dentists use to prevent and manage carious lesions. In addition, new methods for

    identifying carious lesions are beginning to appear, and new approaches for the

    management of individual carious lesions and for the management of individuals

    deemed to be at elevated risk for experiencing carious lesions are emerging. A

    systematic review of the literature was conducted to address three related questions

    concerning the diagnosis and management of dental caries: (1) the performance

    (sensitivity, specificity) of currently available diagnostic methods for carious lesions,

    (2) the efficacy of approaches to the management of noncavitated, or initial carious

    lesions, and (3) the efficacy of preventive methods in individuals who have

    experienced or are expected to experience elevated incidence of carious lesions.

    Search Strategy

    We conducted two detailed searches of the relevant English language literature from

    1966 to October 1999 using MEDLINE, EMBASE, and the Cochrane Controlled Trials

    Register. We did not pursue reports in the gray literature, i.e., information not

    appearing in the periodic scientific literature. We did hand-search current journals up

    to the end of 1999. One search focused on six diagnostic methods (visual and

    visual/tactile inspection, radiography, fiberoptic transillumination, electrical

    conductance, laser fluorescence) and combinations of these methods. A second

    search focused on preventive or management methods for carious lesions, including

    fluorides, pit and fissure sealants, health education, dental prophylaxis, oral hygiene,

    dental plaque, chlorhexidine, dental sealants, and cariostatic agents.

    Selection Criteria

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    We included studies in the diagnostic review that used histologic validation of caries

    status and either reported results as sensitivity and specificity of the diagnosis or

    reported data from which these measures could be calculated. We excluded reports of

    diagnostic methods not commercially available. For the review of the dental caries

    management literature, we included only reports concerning methods applied or

    prescribed in a professional setting. Also, we included only studies performed in vivo

    and having a comparison group. In the literature describing the management of

    noncavitated carious lesions, we included only studies where the lesion was the unit

    of analysis. In the literature describing the management of subjects at elevated risk

    for dental caries, we included only studies where such determinations had been made

    on an individual subject level based on carious lesion experience and/or bacteriologic

    testing.

    Data Collection and Analysis

    We selected studies for inclusion from among 1,407 diagnostic and 1,478

    management reports through independent duplicate reviews of titles, abstracts, and,

    where necessary, full papers. We abstracted data (single abstraction, subsequent

    independent review) on 39 diagnostic studies and 27 management studies using

    different forms for the diagnostic and management studies. Similarly, a separate

    quality rating form was completed by the scientific director for the each study.

    Different rating forms were employed for the two types of studies.

    Main Results

    We judged the strength of the evidence describing the validity of all diagnostic

    methods evaluated to bepoor. There were almost no reports of diagnostic

    performance of any method applied to primary teeth, anterior teeth, and root

    surfaces. For posterior occlusal and proximal surfaces of permanent teeth, the

    number of available studies was sufficient for some but not all methods. However,

    where numbers of studies were sufficient, their quality and/or the variation among

    studies precluded establishing unambiguous assessments of sensitivity and specificity.

    The variation in sensitivity among methods was generally similar to the variation

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    reported within methods. With the exception of electrical conductance, dental caries

    diagnostic methods featured criteria that maximized specificity at the expense of

    sensitivity: false positive diagnoses were proportionally infrequent compared with

    false negative diagnoses. In addition to the limited numbers of studies for certain

    teeth and methods, the literature on diagnosis displayed a variety of serious

    limitations, including the predominance of in vitro studies, small numbers of

    examiners, high prevalences of lesions, and inadequate descriptions of subject

    selection, examiner training and reliability, and criteria for diagnoses.

    The literature on the management of noncavitated carious lesions consisted of five

    studies describing seven experimental interventions. Because these interventions

    varied extensively in terms of management methods tested as well as other study

    characteristics, no conclusions about the efficacy of these methods were possible. We

    rated the evidence for efficacy of methods for the management of noncavitated

    lesions as incomplete. Standardization for the determination of noncavitated status is

    needed for future studies.

    The literature on the management of individuals at elevated risk of carious lesions

    consisted of 22 studies describing 29 experimental interventions. We rated the

    evidence for the efficacy of fluoride varnish for prevention of dental caries in high-risk

    subjects as fairand the evidence for all other methods as incomplete. Because the

    evidence for efficacy for some methods, including chlorhexidine, sucrose-free and

    xylitol-containing gum, and combined chlorhexidine-fluoride methods, is suggestive

    but not conclusive, these interventions represent fruitful areas for further research.

    Conclusions

    The strength of the evidence available to estimate the validity of diagnostic methods

    for carious lesions dental caries is insufficient to the task. For many applications,

    there are few studies, and when sufficient numbers of studies are available,

    substantial variation among studies and/or the quality of the studies is problematic.

    The literature describing the management of two specific dental caries-related

    conditions, nonsurgical interventions for noncavitated lesions and prevention of

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    lesions in persons at elevated risk for new lesions, is inadequate to permit conclusions

    about the efficacy of most methods. Only for two specific applications, fluoride

    varnishes in caries-active, high-risk individuals and fluoride-based interventions for

    individuals receiving radiotherapy was the evidence rated as fair. For all other

    management methods, the evidence was judged to be incomplete. The need for

    efficacy determinations is acute as much of modern preventive dental practice is

    predicated on the efficacy of management methods for these conditions.

    This document is in the public domain and may be used and reprinted without

    permission except those copyrighted materials noted for which further reproduction is

    prohibited without the specific permission of copyright holders.

    Suggested Citation

    Bader JD, Shugars DA, Rozier G, et al. Diagnosis and Management of Dental Caries.

    Evidence Report/Technology Assessment No. 36 (prepared by Research Triangle

    Institute and University of North Carolina at Chapel Hill Evidence-based Practice

    Center under Contract No. 290-97-0011). AHRQ Publication No. 01-E056. Rockville,

    MD: Agency for Healthcare Research and Quality. June 2001.

    Summary

    Overview

    Dental caries, or cavities, is a chronic infectious disease experienced by more than 90

    percent of all adults in the United States. Recent changes in the epidemiology of

    dental caries have altered the presentation of the disease so that among children age

    5 to 17 years, about 75 percent of the disease is now experienced in 25 percent of the

    population. Also, as understanding of the disease process has matured, the range of

    management strategies for dental caries has broadened.

    Interventions to arrest or reverse the demineralization process that characterizes the

    development of a carious lesion are available, and several strategies for identifying

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    those persons representing the quarter of the population who will experience an

    elevated incidence of dental caries have been reported.

    The growing sophistication in available interventions for prevention and nonsurgical

    treatment of dental caries is matched by a similar increase in the available methods

    for diagnosis of carious lesions. The diagnosis of carious lesions has been primarily a

    visual process, based principally on clinical inspection and review of radiographs.

    Tactile information obtained through use of the dental explorer or "probe" has also

    been used in the diagnostic process. The development of some alternative diagnostic

    methods, such as fiberoptic transillumination (FOTI) and direct digital imaging

    continue to rely on the dentist's interpretation of visual cues, while other emerging

    methods, such as electrical conductance (EC) and computer analysis of digitized

    radiographic images, offer the first "objective" assessments, where visual and tactile

    cues are either supplemented or supplanted by quantitative measurements.

    This relatively recent growth in alternatives available for both diagnosis and

    management of dental caries has yet to be fully assimilated by dental practice.

    Thorough reviews of methods for diagnosis and management of dental caries should

    assist in that assimilation process.

    Reporting the Evidence

    The clinical questions in this report were developed in conjunction with the planning

    committee for the Dental Caries Consensus Development Conference on the Diagnosis

    and Management of Dental Caries Through Life (to be held in 2001). The questions

    reflect three aspects of the diagnosis and management of dental caries where the

    committee perceived either that current clinical practice might not reflect current

    knowledge regarding efficacy and effectiveness, or that a review of current evidence

    might help stimulate new research.

    The first question addresses methods used in caries diagnosis asking what the validity

    of each diagnostic technique is. Diagnoses of carious lesions must be made in a

    variety of sites -- primary and permanent teeth, occlusal and smooth surfaces, and

    coronal and root surfaces.

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    Several diagnostic techniques are available, and the ability of these different

    techniques to detect carious lesions on specific sites is not widely understood.

    The second question concerns the efficacy of nonsurgical strategies to arrest or

    reverse the progress of carious lesions before tooth tissue is irreversibly lost. The

    relative effectiveness of these conservative treatments is not well identified.

    The third question addresses the efficacy of preventive methods among those

    individuals who have experienced, or are expected to experience, an elevated

    incidence of carious lesions. Dentists are now being urged to identify individuals with

    elevated caries activity, but this risk assessment strategy has not been complemented

    by the identification of the most effective interventions to mitigate the expected caries

    attack.

    Methodology

    Search Process and Inclusion Criteria

    The Evidence-based Practice Center (EPC) review and investigative team conducted

    two detailed searches of the relevant English language literature from 1966 to

    October 1999 using MEDLINE, EMBASE, and the Cochrane Controlled Trials Register.

    The team did not pursue reports in the gray literature (i.e., information not reported

    in the periodic scientific literature). The team hand-searched current journals up to

    the end of 1999.

    One search focused on the following diagnostic methods -- visual and visual tactile

    inspection, radiography, fiberoptic transillumination, electrical conductance, laser

    fluorescence, and combinations of these methods -- using keywords for the disease

    (dental caries, tooth demineralization), diagnostic concepts (oral diagnosis, oral

    pathology, dental radiography), and study characteristics and design.

    A second search focused on dental caries preventive or management methods, using

    keywords for methods (fluorides, pit and fissure sealants, health education, dental

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    prophylaxis, oral hygiene, dental plaque, chlorhexidine dental sealants, cariostatic

    agents) and study characteristics and design in addition to the disease keywords.

    The EPC team applied several inclusion and exclusion criteria to the reports identified

    in our literature search. The team included studies in the diagnostic review that used

    histological validation of caries status, and either reported results as sensitivity and

    specificity of the diagnosis or reported data from which these measures could be

    calculated. The team excluded reports of diagnostic methods not commercially

    available. For the review of the dental caries management literature, the team

    included only reports concerning methods applied or prescribed in a professional

    setting, and only studies performed in vivo and having a comparison group.

    The two disease management questions that were addressed by the team used the

    results of the management review and featured additional inclusion criteria. For the

    management of non-cavitated carious lesions, the team included only studies where

    the lesion was the unit of analysis. The team accepted several different descriptions of

    noncavitated lesions (including the terms "incipient" and "initial)." From the literature

    describing the management of subjects at elevated risk for dental caries, the team

    included only studies where the classification of elevated risk had been made for

    individual subjects and was based on carious lesion experience and/or bacteriological

    testing. The team accepted the elevated risk classification described in the paper.

    The EPC team selected studies for inclusion from among 1,407 diagnostic and 1,478

    management reports through independent duplicate reviews of titles, abstracts, and,

    where necessary, full papers, with discussion leading to consensus where

    disagreement occurred. Two team reviewers agreed on inclusion status for 97 percent

    of the reports at this stage. In addition, the reviewers separately identified six studies

    evaluating preventive methods in patients who had received radiotherapy for head

    and neck neoplasms (a special high-risk group) and seven studies evaluating

    preventive methods in patients with orthodontic bands or brackets (another special

    high-risk group). The team believed that these studies should be included in the

    review, but not combined with the main group of studies due to substantial

    differences in lesions and study methods.

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    The team abstracted data (single abstraction, subsequent independent review) on 39

    diagnostic studies and 27 management studies, using different forms for the

    diagnostic and management studies. Four reviewers were involved in the abstraction

    process, with reviewer agreement rates of 100 percent for results and 88 percent for

    other study descriptors. Separate quality rating forms were completed by the EPC

    team's scientific director for the two types of studies. The quality rating scales

    assessed several elements of internal validity, including study design, duration,

    sample size, blinding, baseline assessments of differences among groups, loss to

    followup, and examiner reliability. Two items also requested the reviewer's subjective

    assessment of both the internal and external validity of the study.

    The team compiled the abstracted data in a series of six evidence tables, one each for

    in vivo and in vitro radiographic studies, studies of management of noncavitated

    carious lesions and individuals at elevated risk for carious lesions, and studies of

    special populations of orthodontic patients and patients who received head and neck

    radiotherapy. The team then graded the evidence summarized in the tables.

    For the diagnostic question, the strength of the evidence was judged in terms of the

    extent to which it offered a clear, unambiguous assessment of the validity of a

    particular method for identifying a specific type of lesion on a specific type of surface.

    The three possible ratings were:

    Good (A): The number of studies is large, the quality of

    the studies is generally high, and the results of the studies

    represent narrow ranges of observed sensitivity and specificity.

    Fair (B): There are at least three studies, the quality of

    the studies is at least average, and the results represent

    moderate ranges of observed sensitivity and specificity.

    Poor (C): There are fewer than three studies, or the

    quality of the available studies is generally lower than average,

    and/or the results represent wide ranges of observed

    sensitivities and/or specificities.

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    For purposes of this question, a narrow range is defined as no more than 0.15 on a

    scale of 0.0 to 1.00, a moderate range is no more than 0.35, and a wide range is

    more than 0.35. High quality is defined as most study scores at or above 60, and

    average quality is defined as most study scores at or above 45.

    For the management studies, the team used a scheme based on several

    considerations, including the magnitude of the results reported, the quality rating

    scores of the studies, the number of studies, and the consistency of the results across

    studies. The EPC team's scientific and clinical directors independently rated the

    interventions and developed an adjudicated final rating. The four possible ratings

    were:

    Good (A): Data are sufficient for evaluating efficacy.

    The sample size is substantial, the data are consistent, and the

    findings indicate that the intervention is clearly superior to the

    placebo/usual care alternative.

    Fair (B): Data are sufficient for evaluating efficacy. The

    sample size is substantial, but the data show some

    inconsistencies in outcomes between intervention and

    placebo/usual care groups such that efficacy is not clearly

    established.

    Poor (C): Data are sufficient for evaluating efficacy. The

    sample size is sufficient, but the data show that the

    intervention is no more efficacious than placebo or usual care.

    Incomplete Evidence (I) Data are insufficient for

    assessing the efficacy of the intervention, based on limited

    sample size and/or poor methodology.

    Findings

    Diagnostic Methods

    The EPC team evaluated the strength of the evidence describing the performance of

    diagnostic methods separately for cavitated lesions, lesions involving dentin, enamel

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    lesions, and any lesions. The team also separated the evaluations by the surface and

    tooth type involved. The team found 39 studies reporting 126 histologically validated

    assessments of diagnostic methods.

    There are few assessments of the performance of any

    diagnostic methods for primary or anterior teeth and no

    assessments of performance on root surfaces. The strength of

    the evidence describing the performance of any method for

    these teeth and surfaces ispoor.

    Among studies assessing diagnostic performance for

    proximal and occlusal surfaces in posterior teeth, the team

    rated the strength of the evidence describing the performance

    of visual/tactile, FOTI, and laser fluorescence methods aspoor

    due to the small numbers of studies available.

    The team also rated the strength of the evidence for

    radiographic, visual, and EC methods aspoorfor all types of

    lesions on posterior proximal and occlusal surfaces. However,

    these ratings were due less to inadequate numbers of

    assessments than to variation among reported results. In one

    instance, the quality of the available studies was the principal

    reason for the rating.

    For all but EC assessments, specificity of a diagnostic

    method was generally higher than sensitivity. Thus, false

    negative diagnoses are proportionally more apt to occur in the

    presence of disease than are false positive diagnoses in the

    absence of disease.

    The evidence did not support the superiority of either

    visual or visual/tactile methods. The number of available

    assessments was small and there was substantial variation

    among reports for each method.

    The evidence suggests, but is not conclusive, that some

    digital radiographic methods offer small gains in sensitivity

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    compared with conventional film radiography on both proximal

    and occlusal surfaces.

    The evidence also suggests, but is not conclusive, that

    EC methods may offer heightened sensitivity on occlusal

    surfaces, but at the expense of specificity.

    The diagnostic performance literature is limited in terms

    of numbers of available assessments for most diagnostic

    techniques overall, and especially for primary teeth, anterior

    teeth, and root surfaces and for visual/tactile and FOTI

    methods. The literature is further limited by threats to both

    internal and external validity represented by incomplete

    descriptions of selection and diagnostic criteria and examiner

    reliability, the use of small numbers of examiners,

    nonrepresentative teeth, samples with high lesion prevalence,

    and a variety of reference standards of unknown reliability.

    Management of Noncavitated Carious Lesions

    We found only five studies addressing this topic. The evidence was rated as

    incomplete.

    This literature is limited by:

    Differences in treatment provided to comparison groups

    and in how noncavitated lesions are defined.

    Problems in the identification and control of patient

    exposure to community-based and individual preventive dental

    procedures.

    High loss to followup due in part to limiting analyses

    only to full participants.

    All of these limitations make drawing conclusions difficult.

    Management of Caries-Active Individuals

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    The EPC team evaluated the evidence for nine management methods: fluoride

    varnishes, fluoride topical solutions, fluoride rinses, chlorhexidine varnishes,

    chlorhexidine topicals, chlorhexidine rinses, combined chlorhexidine-fluoride

    applications, sealants, and other approaches. The team based its review on 22 studies

    that described 29 experimental interventions evaluating these. The team also

    examined 13 studies of special at-risk populations (orthodontic and head and neck

    radiotherapy patients).

    The team rated the evidence for the efficacy of fluoride

    varnishes as fair, and the evidence for all other methods as

    incomplete.

    The evidence for efficacy was suggestive for

    chlorhexidine varnishes and gels, for combination treatments

    including chlorhexidine, and for sucrose-free gum, but in each

    instance the number of studies was too small or the results

    were too variable to be conclusive.

    Among subjects undergoing orthodontic treatment with

    attached bands or brackets, the team found the evidence for

    efficacy of fluoride interventions to be suggestive but

    incomplete. Evidence was also incomplete for all other

    prevention methods for these subjects.

    Among patients receiving head and neck radiotherapy,

    the literature offers fairevidence of the efficacy of fluoride-

    based interventions. The evidence was incomplete for any other

    types of preventive interventions among these patients.

    The team found no reports of substantive harms

    associated with any interventions.

    The team found the number of available studies for any

    specific method to be a serious limitation. Among studies

    addressing a method, the variety of experimental protocols,

    comparison groups, and other community and individual

    preventive dentistry exposures further restricted the

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    opportunity to draw conclusions about the efficacy of the

    method. Finally, generalization from the studies to the broader

    U.S. population is problematic, as nearly all studies included

    only children and evaluated changes only in the permanent

    dentition.

    Future Research

    Research is needed to evaluate the performance of all diagnostic methods currently

    available to dental practitioners. Such research should focus on in vivo settings to the

    extent possible, despite difficulties imposed by the requirement for histological

    validation in that environment. Methods for histological validation should be

    standardized, and a standard reporting format for evaluation of diagnostic

    performance should be formulated. Several aspects of study designs in this literature

    should be strengthened, including using samples with representative lesion

    prevalences and presentations, increasing the numbers of examiners whose

    performance is assessed, and ensuring examiner blinding for determinations of both

    experimental diagnoses and reference standards. Finally, research is needed to

    evaluate the "downstream" performance of diagnostic methods; i.e., the

    appropriateness of treatment provided in response to the diagnosis and diagnostic

    performance in detection of changes in lesion volume.

    Additional clinical studies examining outcomes of management strategies for

    noncavitated lesions and for caries-active patients are clearly needed. Here

    investigators must be encouraged to contribute studies that fill identified gaps, that

    build upon existing findings, and that use methods that facilitate comparison across

    studies. Funders and editors are important gatekeepers in this respect.

    Whenever possible, studies should use comparison groups representing the most

    common alternative treatment, and they should document all professional,

    community, and individual preventive dentistry exposures for all subjects. Intention to

    treat analyses, where all outcomes of all subjects enrolled at baseline are included in

    the analyses, are to be encouraged as well.

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    Secondary analyses of existing studies of preventive agents might be exploited in the

    short-term to augment the meager store of knowledge for both noncavitated lesions

    and caries-active individuals. However, some additional efforts need to be extended

    for the development of valid standard criteria for these classifications.

    Chapter 1. Introduction

    Primary Objectives and Scope of this Evidence Report

    The National Institute of Dental and Craniofacial Research (NIDCR) is collaborating

    with the Agency for Healthcare Research and Quality (AHRQ) in supporting a series of

    systematic analyses of oral health topics at the beginning of the new century. NIDCR

    selected dental caries as the inaugural topic in the series partly because current

    approaches to diagnosis, treatment, and prevention of this most widespread of

    chronic diseases have become subjects of increased interest as the expression of the

    disease in the population has changed.

    NIDCR has scheduled a National Institutes of Health (NIH) NIDCR Consensus

    Development Conference (CDC) on Diagnosis and Management of Dental Caries

    Through Life. The conference will address most aspects of the diagnosis and

    prevention of dental caries. The Evidence-based Practice Center (EPC) was asked to

    "anchor" the conference through the preparation and presentation of evidence-based

    reviews for selected aspects of conference topics. An objective of the CDC, and the

    principal objective of the evidence report, is to identify valid diagnostic methods for

    various lesions and effective professional preventive strategies for specific types of

    lesions and patients.

    The treatment of dental caries has long claimed the majority of dentists' efforts, and

    until the last three decades, much of that effort was devoted to repairing teeth that

    had suffered irreversible loss of tissue and removing teeth deemed unsalvageable.1

    With the advent of water fluoridation, fluoridated dentifrices, and both community-

    based and professional fluoride treatments, the nature of the disease has gradually

    changed for the majority of the population, who now experience what can be

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    characterized as a more gradual and limited caries onset, with fewer lesions

    manifesting and progression of these lesions seemingly occurring more slowly.2 For a

    minority of individuals, however, caries incidence continues unabated, with the result

    that although caries is still ubiquitous, a relatively small proportion of the population

    now bears a large majority of the disease in terms of the number of lesions

    experienced.3 Thus, dentists now routinely encounter a distribution of disease among

    their patients that was uncommon two decades ago.

    Concomitantly, as knowledge of the carious process is progressively refined, dentists

    are increasingly urged to view dental caries as a chronic infection, and more attention

    is being paid to the elimination of the infection as a key step in treatment.4

    Also,

    nonsurgical treatment interventions are gaining in popularity as alternatives to

    mechanical replacement of damaged tooth tissue with artificial materials. Thus, at the

    same time that differences among patients in caries activity and perceived caries risk

    are raising new questions about the appropriate preventive and treatment strategies

    for individual patients, the range of possible strategies that can be applied to these

    patients is increasing.

    This growing complexity in methods for caries management is matched by a similar

    increase in the complexity in methods for caries diagnosis. The diagnosis of carious

    lesions has been primarily a visual process, based principally on clinical inspection and

    review of radiographs. Tactile information obtained through use of the dental explorer

    or probe has also been used in the diagnostic process. Chiefly because these methods

    depend on subjective interpretation of subtle visual and tactile cues, variation among

    dentists' diagnoses had tended to be extensive.5

    Some developing alternative

    diagnostic methods, such as fiberoptic transillumination (FOTI) and direct digital

    imaging, continue to rely on dentists' interpretation of visual cues, whereas other

    emerging methods, such as electrical conductance (EC) and computer analysis of

    digitized radiographic images, offer the first "objective" assessments, where visual

    and tactile cues are either supplemented or supplanted by quantitative

    measurements.

    Key Clinical Questions

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    The clinical questions in this report were developed in conjunction with the planning

    committee for the CDC. They reflect three aspects of the diagnosis and management

    of dental caries where the committee perceived either that current clinical practice

    might not reflect current knowledge regarding efficacy and effectiveness or that a

    review of current evidence might help stimulate new research.

    The first question addresses methods used for identifying carious lesions. At issue is

    the validity of each diagnostic technique. Lesions must be identified in a variety of

    sites -- primary and permanent teeth, occlusal and smooth surfaces, and coronal and

    root surfaces. Several diagnostic techniques are available, and the ability of these

    different techniques to detect carious lesions on specific sites may not be completely

    appreciated.

    The second question concerns the effectiveness of strategies to arrest or reverse the

    progress of carious lesions before tooth tissue is irreversibly lost. Early stages of

    dental decay involve demineralization of tooth tissues with minimal loss of the organic

    matrix. In some instances, dentists can promote remineralization of the matrix, thus

    effectively reversing the caries process.6 In other instances, the affected area can be

    covered with a protective material without any surgical removal of tooth tissue. The

    efficacy of these conservative, nonsurgical caries treatments is not well identified.

    The third question addresses the effectiveness of preventive methods in those

    individuals who have experienced, are experiencing, or are expected to experience an

    elevated incidence of carious lesions. Dentists are now being urged to identify

    individuals with elevated caries activity,7but this "risk assessment" strategy has not

    been complemented by the identification of the most effective interventions to

    mitigate the caries attack in these high-risk individuals.

    Technical Expert Advisory Group Involvement

    Guidelines from AHRQ require identification of technical experts in diagnosis and

    management of dental caries. The Technical Expert Advisory Group (TEAG) (see

    Appendix B for its composition) was expected to contribute to (a) advancing AHRQ's

    broader goals of creating and maintaining "science partnerships" and "public-private

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    partnerships" and (b) meeting the needs of a broad array of potential users of its

    products. Thus, it was both a resource and a sounding board throughout the project.

    The TEAG included seven members, three technical experts, two individuals

    representing the public health perspective of the population at large, and two

    potential users of the final evidence report or other materials.

    To ensure scientifically robust work, the TEAG was called upon to provide reactions to

    work in progress and advice on substantive issues or possibly overlooked areas of

    research. TEAG members participated in conference calls and e-mail solicitations:

    At the beginning of the project to discuss the key

    clinical questions, initial drafts of causal pathways, and

    proposed inclusion and exclusion criteria for research articles.

    During the development of abstracting forms to provide

    comments concerning the forms, the content proposed for

    inclusion in the evidence tables, and the final versions of the

    key clinical questions and causal pathways.

    When the draft evidence tables were produced to

    discuss the content of the tables and the completeness of the

    search.

    Because of their extensive knowledge of the caries literature and their active

    involvement in professional societies, TEAG members were also asked to participate in

    the peer review process by commenting on the draft report. In addition to the

    contribution of the TEAG, the preparation of the evidence report also benefited from

    the contributions of three consultants whose advice was sought informally during all

    phases of the project. Subject to their availability, the consultants also participated in

    the conference calls.

    Dental Caries: Background and Significance

    Dental caries is a chronic infectious disease that results in the destruction of tooth

    tissue. It is caused by a complex interaction of oral microorganisms in dental plaque,

    diet, and a broad array of host factors ranging from societal and environmental

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    factors to genetic and biochemical/immunologic host responses.8 Dental caries is also

    site specific as each tooth and each site have different susceptibilities because of their

    unique anatomical, physiologic, and environmental characteristics. The crown or

    coronal portion of a tooth is covered by a layer of enamel. The occlusal surfaces of

    posterior crowns have invaginations termed pits and fissures, whereas the facial,

    lingual, and proximal aspects of tooth crowns typically are smooth. In contrast, the

    tooth root consists of dentin covered by only a thin layer of cementum. These

    anatomical variations provide different environmental niches that permit very

    different forms of plaque to flourish.

    Dental tissues are in a constant state of mineralization and demineralization because

    the acidogenic plaque adjacent to enamel surfaces. When this dynamic balance is

    disrupted, the caries process can proceed and can result in the destruction of tooth

    tissue. Initially there is a diffusion of acids into the enamel and subsurface

    demineralization begins to occur. Loss of subsurface enamel can result in a

    noncavitated lesion, or white spot lesion. If the balance of the equilibrium shifts to

    remineralization, the subsurface layer of enamel can be reformed by deposition of

    calcium and phosphate. However, when demineralization dominates, the subsurface

    lesion becomes so large that the surface layer of enamel collapses causing cavitation.

    Cavitated and noncavitated lesions can progress through the enamel to the

    dentoenamel junction (DEJ). Once in dentin, the lesion progresses by following the

    dentinal tubules and spreads laterally in a saucer-shape fashion. Root surfaces, which

    are composed of a thin layer of cementum over dentin, are much rougher than

    coronal (enamel) surfaces, facilitating plaque formation. Compared with coronal

    lesions, root lesions have less well-defined margins and exhibit a broad pattern of

    progression through the dentin.

    Prevalence of Carious Lesions

    The Third National Health and Nutrition Examination Survey-Phase I (NHANES III),

    conducted from 1988 to 1991, provides the most recent estimates of the prevalence

    of carious lesions in the United States.9,10 This survey, which produced nationally

    representative estimates for the civilian noninstitutionalized U.S. population, found

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    that the mean decayed and filled surfaces (dfs) of primary teeth score in children age

    2 to 9 was 3.1. The score varied among racial-ethnic categories: non-Hispanic whites

    (2.5), non-Hispanic blacks (2.7), and Mexican-Americans (4.8). Overall, 83 percent of

    children age 2 to 4 years had experienced no lesions in the primary dentition, with

    this percentage dropping to 50 percent in children 5 to 9 years of age.

    Table 1. Mean DS, DMFS, and % DS/DMFS per person by race-ethnicity (more...)

    Table 1. Mean DS, DMFS, and % DS/DMFS per person by race-ethnicity in

    U.S. children and adolescents age 5 to 17, 1988-91

    Race/Ethnicity DS (SE) DMFS (SE) % DS/DMFS (SE) 1

    Total 0.4 (0.1) 2.5 (0.2) 19.7 (1.5)

    Non-Hispanic Whites 0.3 (0.0) 2.4 (0.3) 14.6 (2.2)

    Non-Hispanic Blacks 0.8 (0.1) 2.5 (0.2) 37.9 (3.1)

    Mexican-Americans 0.7 (0.1) 2.7 (0.1) 36.4 (2.8)

    The overall mean decayed, missing, and filled surfaces (DMFS) of permanent teeth

    scores for children age 5 to 17 in various racial-ethnic categories are shown in Table

    1, together with the D component scores and the D/DMF proportion, which represents

    the relative proportion of an individual's disease experience that has not received

    treatment. In this age group, overall DMFS was similar across race-ethnicity

    categories, but the proportion of DS in the DMFS varied substantially by race-ethnicity

    categories, which may be more of a reflection of access or utilization issues rather

    than disease patterns.

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    In children age 5 to 11, 74 percent had no carious lesions in the permanent dentition,

    whereas for children age 12 to 17, the proportion falls to 33 percent. Overall, carious

    lesions in children are not evenly distributed; 75 percent of overall caries experience

    in permanent teeth occurred in approximately 25 percent of the population.3 Thus,

    although the majority of children have moderate decay or less, carious lesions are a

    recurring problem for a substantial minority. Carious lesions are also not equally

    distributed across tooth surfaces in this population, as occlusal surfaces experience

    lesions five times more frequently than the mesial and distal (smooth) surfaces.

    Table 2. Mean DS, DFS, and %DS/DFS per person by race-ethnicity in (more...)

    Table 2. Mean DS, DFS, and %DS/DFS per person by race-ethnicity in U.S.

    dentate adults, ages 18 Years and older, 1988-91

    Race/Ethnicity DS (SE) DFS (SE) %DS/DFS (SE) 1

    Total 1.8 (0.0) 22.2 (0.9) 14.2 (0.8)

    Non-Hispanic Whites 1.5 (0.1) 24.3 (1.5) 10.6 (0.8)

    Non-Hispanic Blacks 3.4 (0.3) 11.9 (3.4) 35.4 (2.8)

    Mexican-Americans 2.8 (0.3) 14.1 (2.8) 31.0 (2.6)

    In adults 18 and older, evidence of past or present coronal carious lesions was found

    in 94 percent of the population. The mean DFS score for dentate adults (those with

    one or more teeth) was 22.2. Females exhibited a higher mean number of treated and

    untreated surfaces per person. Coronal DFS scores, shown in Table 2, varied by race-

    ethnicity, and the proportion of decayed surfaces in the DFS score varied as well.

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    Carious root lesions were found in 23 percent of the dentate population overall and in

    more than 47 percent of individuals 65 or older. The average number of treated and

    untreated root surfaces ranged from a low in non-Hispanic whites of 1.1 to 1.4 in

    Mexican-Americans and 1.6 in non-Hispanic blacks.

    Burden of Illness from Dental Caries

    Because treatment and/or prevention of carious lesions is one of several reasons for

    visiting a dentist, and because accurate information describing reasons for dental

    visits is not available, the extent to which carious lesions necessitate dental visits is

    not known. However, from the preceding section on the prevalence of carious lesions

    and filled tooth surfaces, it would seem that racial and ethnic minorities receive

    proportionally less treatment for carious lesions than do white non-Hispanics. This

    observation is supported from existing data on dental visits. The Surgeon General's

    report on oral health11 has assembled data from a number of Federal agencies that

    paint a clear picture of differences in the receipt of oral health care by race/ethnicity,

    income, and insurance status. In white, non-Hispanic adults, 64 percent reported a

    dental visit in 1993 compared with 47 percent of black, non-Hispanic adults and 46

    percent of Hispanic adults. For individuals with incomes at or above poverty level, 64

    percent reported a dental visit in the previous year compared with 36 percent for

    those with incomes below poverty level. In 1989, 70 percent of individuals 2 years

    and older with private dental insurance reported a dental visit within the preceding

    year compared with 51 percent for those without private dental insurance. Finally,

    those individuals who rate their oral health as very good or excellent are more likely

    to have visited a dentist in the preceding year (61 percent) than were those assessing

    their health as fair or poor (45 percent).

    The economic cost of dental caries is also difficult to assess precisely. In 1998,

    Americans spent more than $53 billion on dental services.11 From an analysis of

    insurance claims, approximately 40 percent of charges are related to restorative

    dental services, which are usually, but not always, performed to repair teeth damaged

    by carious lesions.12 Thus, even without adding in the cost of more complex services

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    necessary to restore function lost as a result of the sequalae of the dental caries

    process, expenditures related to caries were more than $20 billion.

    Beyond the direct economic costs of dental treatment, there are the less directly

    calculable costs associated with the loss of working time, missed school, and reduced

    levels of social functioning. The National Health Interview Survey (NHIS) indicates

    that 2.9 million acute dental conditions occurred in the U.S. population during 1994.

    These dental conditions accounted for an estimated 3.9 million days of missed work in

    persons 18 years of age and over, 1.2 million days of missed school in youth 5 to 17

    years of age, and 12.2 million days of restricted activity across all ages (e.g.,

    nonperformance of usual family role activities).13

    The NHIS methods may

    underestimate the actual amount of missed time from school and work and restricted

    activity days for dental conditions.14,15

    Studies of how dental caries affects quality of life are much less empirically

    compelling, but experts agree on what the potential effects of dental caries are likely

    to be in the short and long term.16 In the short term, physical discomfort and pain are

    the most likely consequences of untreated lesions. Physical impacts can be felt

    directly as through the pain of toothaches, infections, and temporomandibular joint

    disorder resulting in part from a loss of posterior teeth and the failure to replace them

    when necessary. The possible eventual inability to eat -- both bite and chew --

    because of tooth loss can lead to unnecessary dietary restrictions and nutritional

    deficiencies as well as complicate the dietary management of other chronic health

    conditions.

    The psychological pain of self-consciousness and social isolation may also accompany

    the embarrassment of the unsightly deterioration of anterior teeth caused by dental

    caries. The same psychological distress can result from the embarrassment of missing

    anterior teeth, the communication dysfunction associated with not being able to be

    easily understood by others, and the isolation or withdrawal from social intercourse

    because of missing teeth. In the long term, left untreated, carious lesions may lead to

    the loss of such teeth, the replacement of which may be needed for functional, social,

    cosmetic, and physical and mental health reasons.

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    Caries Diagnosis

    The local result of the dental caries infection is a process of demineralization of tooth

    tissue (enamel, dentin, cementum). Acid produced by bacteria as a product of

    carbohydrate fermentation causes the demineralization. The diagnosis of dental caries

    at a particular site on a tooth is based on either direct or indirect detection of the

    demineralized tooth structure.

    The principal methods dentists use to diagnose carious lesions -- visual and

    visual/tactile examinations and radiographic assessment -- have been employed with

    little change for decades. Refinement in techniques, rather than development of new

    technology, has characterized these methods over the years. Illumination has

    improved and magnification is more easily employed for visual examinations, whereas

    radiation doses have decreased for radiographic assessment as both equipment and

    film have been improved.

    Visual inspection is based on a search for signs of demineralization, which include

    changes in color and in surface consistency and contour. Tactile inspection is usually

    accomplished with a fine-tipped dental explorer or probe that is passed over smooth

    surfaces of teeth as well as pits and fissures. On smooth surfaces, the surface texture

    is assessed for roughness as well as breaks in contour. In pits and fissures, the probe

    is usually pressed with differing levels of force into depressed areas to assess whether

    any penetration is possible and whether there is any resistance to withdrawal of the

    probe. Radiographic assessment is based on identification of demineralization of tooth

    tissue through differential exposure of film. Demineralized tooth tissue is less

    resistant to the passage of ionizing radiation and thus appears darker on film images.

    More recently, new technologies have begun to appear that further refine radiographic

    diagnosis of carious lesions and offer alternatives to this technology. Digital

    radiographic techniques eliminate film by capturing radiographic images on phosphor

    storage plates or charge-coupled devices. The images can then be manipulated to

    enhance diagnostic features. Fiberoptic transillumination, passing a narrow beam of

    light through tooth tissue, has become an adjunctive diagnostic method now used for

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    both anterior and posterior teeth, principally on proximal surfaces. Demineralized

    tooth tissue appears dark when transilluminated because of its decreased

    transmission of light. This method represents refinement of the traditional technique

    of transilluminating the anterior proximal surfaces using a mouth mirror and the

    operatory light. Measuring the resistance of tooth tissue to an electrical current

    passed through it is another approach to caries diagnosis, especially of occlusal

    fissure caries. First demonstrated in the 1950s, the technique has been progressively

    refined, with devices available commercially since the 1980s. The technique depends

    on the fact that when enamel becomes demineralized, it loses much of its resistance

    to electrical charges, hence its conductance increases.

    The extent of variation in the diagnosis of dental caries is substantial among dental

    practitioners using the traditional techniques. Typically agreement among several

    dentists is poor to moderate, with kappa values ranging from 0.30 to 0.60 in several

    studies.5 The range of positive diagnoses (proportion of teeth diagnosed as carious) is

    typically wide for any given sample, often spanning 30 to 40 percentage points.5 The

    problem of calibrating dental practitioners to an objective standard for caries

    diagnosis results to a large extent from the absence of objective criteria for the

    diagnosis;17,18 consequently, dentists tend to develop widely different subjective

    patterns or "scripts" that they then use for identification of carious lesions.19This

    variation in the diagnosis of carious lesions is a principal contributor to the still

    greater variation in the decision to restore teeth through irreversible surgical

    intervention20,21 and the concomitant variation in associated costs of those decisions.22

    Professionally Administered Methods of Caries Prevention

    Caries prevention as accomplished in dental practice has traditionally been viewed as

    a combination of several procedures, including oral prophylaxis, topical application of

    fluoride, oral self-care instruction, sealants for fissured surfaces, and restoration of

    existing carious lesions. Although oral self-care instruction and oral prophylaxis

    methods have not changed appreciably over the years, application of topical fluoride

    has seen continuing modifications, both in delivery vehicles and in solutions and

    concentrations used. Dental sealant technology has similarly become refined, with

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    changes in materials and in etching and polymerization techniques. In recent years,

    an additional intervention has become available: prescription antimicrobial

    mouthrinses. Also, the number of "over-the-counter" (OTC) products that dentists can

    specifically recommend for home use has increased, such as remineralization rinses,

    salivary substitutes for persons with decreased salivary flow, and candies and gums

    with nonfermentable sugars. Finally, simplified testing for mutans streptococci (mS),

    the putative pathogen for dental caries, has become commercially available.

    As the incidence of carious lesions experienced by most children has decreased in the

    past three decades, available approaches to prevention in both children and adults

    have become more specific to individual clinical circumstances. The two circumstances

    on which this review is focused involve the management of noncavitated carious

    lesions and the prevention of carious lesions in caries-active individuals. Noncavitated

    carious lesions are areas where demineralization has started, but is not extensive. In

    theselesions, no tissue has been lost and no loss of contour or break in continuity of

    the enamel surface is detectable. Strategies for preventing these lesions from

    progressing to irreversible tissue loss, or cavitation, can include all of the traditional

    and more recently developed preventive techniques. The prevention of new carious

    lesions in caries-active individuals also can involve the full gamut of professionally

    applied preventive procedures.

    Variation in Methods to Control Noncavitated Lesions

    Little is known about dentists' strategies to reduce or eliminate progression of

    noncavitated carious lesions and hence the necessity for surgical intervention. The

    previously cited literature on variation in dentists' decisions to initiate treatment

    includes some studies of dentists' treatment thresholds. These studies suggest there

    is variation in the extent of progression of a carious lesion that individual dentists are

    willing to tolerate before they intervene surgically. Unfortunately, these types of

    studies must be done using patient vignettes, and there is some suggestion that what

    dentists say they do with respect to intervention is often different than what they

    actually do in practice.23-26 These studies show that a sizable proportion of dentists

    routinely intervene when radiographic evidence of dental caries manifests itself in the

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    enamel prior to cavitation. No recent studies are available to document circumstances

    surrounding application of nonsurgical means of control, although the continuing

    controversy about "sealing over caries"27 suggests that dentists vary in their

    willingness to use sealants as a method for the control of unidentified occlusal lesions.

    Variation in Methods to Control Caries in Caries-Active

    Individuals

    Knowledge of dentists' practices in addressing caries control in caries-active

    individuals is exceedingly limited. Only recently have the concepts of "caries risk" and

    "medical management" emerged in the clinical dental literature.4,7,28,29 These

    discussions suggest that practitioners' preventive approaches may not be routinely

    based on a careful assessment of the magnitude of the caries challenge. Information

    from insurance claims suggests that topical fluoride applications tend to vary by

    practitioner, but not by patients within a practice, who all receive the same preventive

    care even though they have different rates for restoration receipt.30 Also, a survey of

    practitioners shows that commonly used clinical protocols are not congruent with

    current recommendations for low-risk individuals.31 Clearly, there is a potential for

    both over use and under use of prevention and control methods in a caries-active

    population; but studies that examine dentists' preventive treatment behaviors are

    rare, and none differentiate treatment by an individual's caries activity.

    Organization of this Report

    The remainder of this report is organized in the following sections. Chapter 2 provides

    details about the literature search and review methods describes the causal pathway

    for key questions and approaches to establishing inclusion and exclusion criteria,

    conducting the systematic review, abstracting data from articles, maintaining quality

    control, assigning quality scores to individual articles, and similar details. Chapter 3

    presents the results for the three key clinical questions -- diagnostic methods,

    management of noncavitated lesions, and management of caries-active individuals.

    Chapter 4 provides conclusions, and Chapter 5 offers recommendations concerning

    research on diagnosis and management of dental caries. References cited in the body

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    of the report, the six evidence tables, and a list of all literature reviewed for the

    preparation of the tables follow. The appendixes contain acknowledgments (Appendix

    A), information on the TEAG (Appendix B) and the peer reviewers (Appendix C), data

    extraction forms (Appendix D), and acronyms and abbreviations used in this report

    (Appendix E).

    Chapter 2. Methodology

    Overview

    This chapter of the report documents the procedures that the Research Triangle

    Institute-University of North Carolina at Chapel Hill Evidence-based Practice Center

    (RTI-UNC EPC) used to develop a comprehensive evidence report that describes and

    contrasts the approaches currently used in the diagnosis of dental caries and in

    management of two specific clinical presentations of dental caries. To set the

    framework for review, the key questions and their underlying causal pathway are

    presented first. This is followed by a detailed description of the literature search,

    which includes descriptions of the Medical Subject Headings (MeSH terms) used in the

    principal search, other search sources, the inclusion and exclusion criteria, and the

    application of these criteria to the results of the searches. Once the RTI-UNC EPC

    team determined that studies met the inclusion/exclusion criteria and were eligible for

    inclusion, the team abstracted data onto Data Extraction Forms and then transferred

    critical information to evidence tables; these forms are also described in this chapter.

    The chapter also discusses quality issues, i.e., the RTI-UNC EPC's quality control

    procedures with regard to determining the eligibility for inclusion, carrying out the

    data abstraction, and developing a quality rating scheme for individual studies. An

    evidence report requires an extensive search of all types of literature. Because the

    criteria for quality ratings will vary by type of study design, the RTI-UNC EPC

    developed quality rating forms specific to the two types of studies included in the

    diagnosis and management reviews. This section describes the development of the

    rating system and its use in the analysis.

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    Key Questions and Causal Pathways

    This report addresses three questions. The first concerns diagnosing carious lesions,

    the second examines strategies for treatment of early carious lesions, and the third

    focuses on management of patients who have multiple carious lesions or are

    perceived to be at high risk for developing lesions. All the questions were put in final

    form with input from the TEAG and the consultants after an original set of questions

    was identified in initial discussions with the planning committee for the CDC on the

    Diagnosis and Management of Dental Caries Throughout Life.

    Final Key Questions

    The key questions address issues of caries diagnosis and management that arise in

    the professional treatment of dental caries, i.e., those procedures that are provided

    by dentists and allied dental personnel in dental practices and clinics. Thus, the

    procedures are limited to those commercially available at the time of this review.

    Further, the caries management questions focus on issues that accompany the

    "modern" view of dental caries as an oral infection that, at specific sites, initially leads

    to demineralization and ultimately destruction of tooth tissue. The key questions,

    stated in final form, are as follows:

    Question 1.

    What are the validities of the available diagnostic

    methods for detecting carious lesions in primary and

    permanent teeth?

    Question 2.

    What are the efficacies of the nonsurgical methods

    available for stopping or reversing the progression of a

    noncavitated coronal carious lesion in a primary or a permanent

    tooth?

    Question 3.

    What are the efficacies of the methods available for

    reducing the incidence of new coronal carious lesions in primary

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    and permanent teeth in individuals who are deemed to be

    "caries active" or at "high caries risk"?

    The first question addresses only the diagnosis of primary caries, i.e., the first carious

    lesion on a tooth surface. Both coronal and root surfaces are included in the review,

    and for coronal surfaces, both primary and permanent teeth are included. Following

    discussion with the TEAG, assessment of test validity was operationalized as the

    sensitivity and specificity of a diagnostic test. The methods to be assessed included all

    those diagnostic methods that are commercially available, including visual and visual-

    tactile inspection, radiography, FOTI, EC, laser fluorescence, and combinations of

    those methods.

    The second question focuses on individual early carious lesions, where

    demineralization has occurred but cavitation has not yet occurred. In the past, this

    type of lesion was either removed surgically and replaced with a restoration or

    monitored or "watched." Dentists generally assumed that many noncavitated lesions

    would progress to cavitation, and based treatment decisions on this assumption. More

    recently, the possibility of remineralizing or at least arresting the demineralization of

    these noncavitated lesions has been considered as an alternative to surgical removal

    and restoration. Another nonsurgical technique, placing dental sealants, is also

    available for noncavitated lesions on fissured surfaces. The question includes

    consideration of a still wider range of potentially useful methods, including

    professional fluoride applications and prescribed supplements, other remineralization

    agents, professional oral hygiene and plaque control programs, and combinations of

    these methods.

    The third question focuses on patients rather than individual carious lesions. It

    reflects the need for information about how to manage patients who have active

    carious lesions or who are at risk of developing such lesions. Recommendations for

    the "medical management" of such patients have appeared; yet the methods to be

    included in such an approach are not well defined. This question includes

    consideration of professional fluoride applications and prescribed supplements,

    sealants, antimicrobial therapy, salivary enhancements, nutritional/diet counseling,

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    professional oral hygiene/plaque control programs, and combinations of these

    methods.

    Causal Pathways

    Figure 1. Causal pathways for the diagnosis, nonsurgical management, (more...)

    Figure 1. Causal pathways for the diagnosis, nonsurgical management, and

    prevention of carious lesions

    Because the questions are closely linked in the typical examination and treatment

    sequence that occurs in dental practice, the RTI-UNC EPC team chose to construct a

    single causal pathway that defines the relationship of the three questions (Figure 1

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    ). The diagnosis of carious lesions is, in reality, an exhaustive search for signs of

    disease on all surfaces of all teeth, using a variety of search techniques. The results of

    the search will drive subsequent treatment decisions. Information from the search will

    include the presence or absence of carious lesions and their pattern of occurrence, the

    degree of penetration of each identified lesion, and whether a lesion is cavitated, i.e.,

    has lost organic material to the extent that the enamel surface has lost its contour.

    The first question examines the accuracy with which the presence or absence (i.e.,

    "any caries") and the depth of penetration (caries affecting the dentin or inner

    structure of the tooth) are identified, as well as the accuracy with which cavitation can

    be detected.

    The degree of penetration of the lesion is thought to be the principal criterion that

    most dentists use in making treatment decisions, with penetration to the dentin

    seemingly the threshold for restoration reported most often. In view of caries

    progression, whether a lesion is cavitated or not may represent a more logical

    criterion for differentiating between opportunities to arrest or reverse caries

    progression nonsurgically and the necessity for removal of the lesion and replacement

    of the lost tissue. The use of dentin penetration as the surgical intervention criterion

    may result in the treatment of noncavitated, potentially reversible lesions. The causal

    pathway reflects the lack of a cavitation criterion for nonsurgical intervention.

    For those patients found to have one or more carious lesions, in addition to surgical or

    nonsurgical treatment directed specifically at the lesion(s), there is an opportunity to

    provide treatment for the purpose of reducing the likelihood for the development of

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    further lesions. As noted, although dentists have long provided professional

    preventive procedures, linking the provision of these procedures to a patient's caries

    activity status, when it has been done, usually has been done informally, with little

    knowledge of the effectiveness of such preventive procedures in patients with high

    rates of disease. Extending this type of targeted intensified prevention to patients

    identified as being at risk for the development of carious lesions is less common.

    Caries risk assessment is a relatively recent development in dentistry; and even

    though a number of risk assessment instruments have been described, the approach

    has not been validated when applied to individual patients.

    Literature Search

    This portion ofChapter 2 documents the literature search process, specifying the

    terms used for each of the literature database searches conducted, as well as

    describing other search strategies and listing the inclusion/exclusion criteria used for

    the initial search and the review of identified studies. It also documents the steps

    taken to identify the relevant studies from among those identified in the searches to

    be included in the evidence report.

    Search Terms

    Table 3. Strategy and results of MEDLINE caries diagnosis search (more...)

    Table 3. Strategy and results of MEDLINE caries diagnosis search

    Wide search of early caries literature

    1 exp dental caries/pa,di.ra 2,846

    2 limit to human, English, 1966-75 219

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    Defining studies of caries

    3 exp tooth demineralization/pa,di,ra 2,928

    4 exp dental caries/ 21,830

    5 3 or 4 21,904

    Limiting 5 to diagnostic methods

    6 exp diagnosis/, oral diagnosis/ 2,420

    7 exp radiography/, dental radiography/, digital dental

    radiology/816

    8 exp pathology/, oral pathology/ 4

    9 1 or 6 or 7 or 8 2,539

    10 limit to human, English 1,776

    Limiting 10 to various study types

    11 controlled clinical trial 21

    12 meta analysis 4

    13 randomized controlled trial 50

    14 epidemiologic study characteristics 244

    15 epidemiologic research design 333

    16 comparative study 457

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    Combining results of 1966-75 "wide" search and searches for

    specific study types

    17 2 or 11 or 12 or 13 or 14 or 15 or 16 1,266

    Adding all root caries studies

    18 exp root caries/pa,di,ra 62

    Total 1,328

    Table 4. Strategy and results of MEDLINE caries management search (more...)

    Table 4. Strategy and results of MEDLINE caries management search

    Identifying management methods

    1 exp fluorides, topical/tu 2,061

    2 exp tooth remineralization/ 445

    3 exp pit and fissure sealants/tu 667

    4 exp health education, dental/ 4,287

    5 exp dental prophylaxis/ 3,699

    6 exp oral hygiene/ 8,624

    8 exp dental plaque/pc,dh,dt,th 3,423

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    9 exp chlorhexidine/tu 1,126

    10 exp xylitol/tu 162

    11 exp tooth demineralization/pc,dt,th 10,162

    12 exp cariostatic agents/tu 3,994

    13 fluoride supplements 60

    14 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or12 or 13

    26,902

    Identifying caries management methods

    15 exp dental caries/pc,dh,dt,th 10,064

    16 14 and 15 10,058

    17 limit to human, English 5,057

    Limiting 17 to various study types

    18 controlled clinical trial 122

    19 randomized clinical trial 177

    20 epidemiologic study characteristics 762

    21 epidemiologic research design 266

    22 comparative study 758

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    Total of 18 or 19 or 20 or 21 or 22 1,435

    Two separate literature searches were conducted for this evidence report -- one for

    the caries diagnosis question and the other for the two caries management questions.

    Tables 3 and 4 show the MeSH terms used for searching MEDLINE, the principal

    database for each of these two searches, as well as the results of the searches. The

    searches were run in October 1999. Although detailed sets of inclusion and exclusion

    criteria had been developed prior to the searches (see following section), few of the

    criteria are evident in the search strategies. Indexing for the dental literature is

    sketchy and unreliable in the first 10 years covered by MEDLINE, and problems exist

    well into the 1980s for some terms of interest in these searches (e.g.,

    demineralization and remineralization). Thus, the search strategies tended to be

    inclusive rather than exclusive. Only at the broadest level could either search be

    limited to human studies, reports in English (because resource constraints), and a

    rather wide variety of study types listed in the tables.

    In the absence of effective exclusion criteria available in MEDLINE, it still might have

    been possible to design relatively "tight" search strategies if certain critical keywords

    were available to narrow the search focus. Unfortunately, this was not the case for

    either search. The diagnosis search returned a large number of potentially eligible

    studies (1,328) because preliminary searches had demonstrated that a key term,

    "sensitivity and specificity," could not be assumed to identify accurately all eligible

    studies.

    In the management search, two critical features of eligible studies could not be

    isolated through use of indexing terms. Neither noncavitated lesions nor caries-active

    or "at-risk" patients are identifiable through the keyword structure. Thus, the

    management search had to be designed to identify all possible evaluations of the

    eligible preventive methods, with subsequent inspection of the abstract or full paper

    required for a final determination of eligibility for either of the systematic reviews

    based on patient sample or type of lesion included. The result was the identification of

    1,435 citations.

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    Additional Searching

    Table 5. Strategy and results for EMBASE caries diagnosis search (more...)

    Table 5. Strategy and results for EMBASE caries diagnosis search

    1. dental adjacent to caries 1,554

    2. diagnosis 248,652

    3. dental radiography 121

    4. 2 and 3 248,677

    5. 1 and 4 87

    6. New citations added (not duplicates with MEDLINE) 79

    Table 6. Strategy and results for EMBASE caries management search (more...)

    Table 6. Strategy and results for EMBASE caries management search

    1. dental adjacent to caries 1,554

    2. topical fluorides 6

    3. remineralizaion 79

    4. dental sealants 13

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    5. sealants 96

    6. chlorhexidine 0

    7. cariostatic agents 0

    8. 2 or 3 or 4 or 5 or 6 or 7 181

    9. 1 and 8 48

    10. New citations added (not duplicates with MEDLINE) 43Subsequent to the principal literature searches in MEDLINE, the team completed

    followup searches in EMBASE and the Cochrane Controlled Trials Register. The search

    terms and results for the EMBASE searches are shown in Tables 5 and 6. The studies

    not duplicated in the MEDLINE searches were added to the two groups of studies

    included in the review. No new studies were found in the Cochrane Library.

    A valuable supplemental search strategy was perusal of the reference sections of

    papers identified in the searches. Again, the reason for the seeming inefficiency of the

    MEDLINE searches is in large measure the imprecise indexing characteristics of dental

    studies in the 1970s and 1980s. Not only are descriptors of study design

    characteristics inexact or missing, but descriptors related to the condition or process

    of interest are also often tangential in nature. This forces the search to be less

    exclusive and at the same time increases the likelihood that some studies will be

    missed, even with a fairly broad search strategy such as the one employed.

    The team had elected at the outset not to complete a detailed search of the gray

    literature. This is information not appearing in the periodic scientific literature, such as

    dissertations, theses, industry reports, unpublished studies, abstracts, and other

    nontraditional sources. The team made this decision because of both limited resources

    and the prevailing experience opinion among RTI-UNC EPC staff that in the absence of

    known sources for such literature, searches were unlikely to yield useful information.

    The team did query NIDCR to identify any in-progress studies that might have

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    recently reported relevant data. The team did not identify other po