SURGICAL PROCEDURE - Phibo® · The use and application of DEFCON Tissue Care® dental implant...

SURGICAL PROCEDURE

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SURGICAL PROCEDURE

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TECHNICAL INFORMATION

The information detailed below is insufficient for proper use of DEFCON Tissue Care® dental implants. The person using them should have sufficient training and information on the dental implantological

technique for the use of DEFCON Tissue Care® dental implants.

See the information detailed in the implant information leaflet prior to use. Ins-tructions for use and maintenance of DEFCON Tissue Care® products are inclu-ded in the documents and procedure manuals of the DEFCON Tissue Care® implant system.

The DEFCON Tissue Care® implant system adds to its innovative and registered de-sign, state-of-the-art technological features, developed exclusively for professionals that deem technology an advantage and design as a benefit.

DEFCON Tissue Care® meets all requirements established by European laws and guidelines regarding the manufacture and distribution of the medical-healthcare pro-ducts.

The healthcare products associated with this document are CE certified. The label of each individual product includes the identification number corresponding to the authorities notified. Impladent, S.L., meets the most rigorous international quality standards for healthcare products, ensuring perfect quality in their products and with ongoing increase in customer satisfaction as its only goal.

The use of components or products not manufactured by Impladent, S.L,.that come into contact with DEFCON Tissue Care® implant system original components manu-factured by Impladent, S.L., under original design specifications, may cause severe injury to the patient, since those non-original components were not considered for use with the ones mentioned in the documents provided by the manufacturer.

The use of non-original components or instruments indicated in this procedure that come into contact with the mentioned components shall automatically render any warranty on Impladent-manufactured products invalid.

The use and application of DEFCON Tissue Care® dental implant system is outside the manufacturer’s control, and the user shall be responsible for any damage or harm the user may cause as a result of product use. Impladent S.L disclaims any responsibility for damages derived from inappropriate handling or use.

Re-use of disposable products may damage their technical specifications, and also carries the risk of tissue infection, surgical failure, prosthodontic failure and/or injury to the patient’s health.

DEFCON Tissue Care® implant system documents are periodically updated in ac-cordance with the status of science and technology. Users of DEFCON Tissue Care® products should periodically request information and should also attend regularly-held training courses on the product and technique. The use and placement of DE-FCON Tissue Care® implants in unsuitable areas and the use of surgical instruments or prosthetic components not included in this procedure may cause severe injury to patients and total loss of the product warranty. DEFCON Tissue Care® implant system is designed to perform tooth rehabilitation on a single or multiple basis ac-cording to the traditional clinical processes included in this document. Cases with insufficient bone for implant fixation, at risk- clinical cases, such as sinus elevations, fillings, advanced surgical techniques, cases with non-parallelism between severe or unsuitable implants, among others, shall be excluded from warranty coverage.

DEFCON Tissue Care® implant system is internationally distributed in various coun-tries with different technical and sanitary regulations and laws, so differences in the procedure content may vary among countries.

Contact an exclusive DEFCON Tissue Care® distributor in your country and request product documents and availability.

Impladent, S.L. Reserves the right to modify and further develop the products inclu-ded in this procedure without prior notice.

All rights reserved. Written authorization by DEFCON Tissue Care® & Impladent, S.L. is required to reprint or process the content of this publication in any format.

DEFCON® Implants, Tissue Care®, TSA® Advance, BNT®, TSH®, Avantblast®, ProUnic®, ProUnic Plus®, Duplit, Softissue, International DEFCON Group®, Ific, VK, Bonetech, Genoral, Esthetic Tissue, DEFCON Esthetics, DEFCON® Surglcal, DEFCON® Prostodontics, DEFCON® Scientific, are registered and/or commercial brands of Impladent, S.L. DEFCON® implants are protected by international patent. Other products and accessories are protected by patents or have patent pending.

Illustrations for this procedure are not scaled.

PROCEDURES BEFORE USING DEFCON®

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04 INTRODUCCIÓN

· DISEÑO

· MICRODISEÑO

· MACRODISEÑO

05 FINALIDAD DE LOS IMPLANTES

· DIÁMETRO

· CONEXIÓN

· PERFIL AUTORROSCANTE

· MICROESPIRAS

06 ESPECIFICACIONES DE INSERCIÓN

· ALTURA DE INSERCIÓN

· CARACTERÍSTICAS DEL IMPLANTE BNT ®

· INDICACIONES CLÍNICAS

· SECTORES DE INSERCIÓN

· DISTANCIA MÍNIMA ACONSEJADA ENTRE DIENTES E IMPLANTES DE

DIFERENTA SERIE

· OPCIONES DE ADITAMENTOS SEGÚN REHABILITACIÓN

PROSTODÓNTICA

09 PLANIFICACIÓN DEL TRATAMIENTO

· HISTORIA CLÍNICA, DIAGNÓSTICO CLÍNICO Y EXPLORACIÓN

· MODELOS DE ESTUDIO

11 INSTRUMENTAL Y CAJA QUIRÚRGICA

12 PREPARACIÓN DEL CAMPO QUIRÚRGICO

12 PROCESO ESTÁNDAR DE LIMPIEZA, DESINFECCIÓN Y ESTERILIZACIÓN DEL INSTRUMENTAL DEFCON®

· LIMPIEZA MANUAL

· LIMPIEZA MECÁNICA

· DESINFECCIÓN

· ESTERILIZACIÓN

14 SECUENCIAS QUIRÚRGICAS DE INSERCIÓN

· INCISIÓN

· PREPARACIÓN DEL LECHO ÓSEO

· SECUENCIA DEL FRESADO

· SECUENCIA QUIRÚRGICA INICIAL

· SECUENCIA QUIRÚRGICA FINAL BNT® SERIE 2




20 ENVASE Y ETIQUETADO IMPLANTE DEFCON®

21 APERTURA DEL ENVASE

22 EXTRACCIÓN DEL IMPLANTE DEL BLISTER

23 INSERCIÓN DEL IMPLANTE

24 DESMONTAJE DEL PORTAIMPLANTE

25 PROCEDIMIENTOS CON DEFCON TISSUE CARE ®

ÍNDICE:

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INTRODUCTION

CORTE HISTOLÓGICO DE HUESO E IMPLANTE SUPERFICIE AVANTBLAST®

DESIGN

DEFCON Tissue Care® implant system is designed to simplify and reduce clinical processes and rehabilitation time, while providing greater esthetics and patient comfort from the very beginning. Tissue care and maintenance are its goals.

This concept, together with the BNT® implant connection standardization, offers not only rewarding results to patients from the very beginning, but it also assumes obtaining greater profits for the dental clinic, as it reduces processes, times and components, apart from obtaining excellent clinical results in the short, medium and long term.

NANODIMENSION – MICRODESIGN.

AVANTBLAST® is the DEFCON Tissue Care® implant system surface. Following the research line for implant surface treatment based on chemical attack, AVANT-BLAST®, is progress and optimization in biological responses, improving results on surfaces obtained with acid etching and later passivation.

The AVANTBLAST® surface, made with a double chemical attack, combines key factors to facilitate the biological response: optimal roughness, increasing the ac-tual implant surface; exclusive, outstanding porosity with a morphology very similar to that of bone tissue, greatly moisturized according to the surface tension of the various biological repair stages; controlled thickness increase of the superficial titanium oxide layer, achieving three times the thickness of the natural layer; and ceramic stoichiometric configuration, resulting in decreased metallic ion release into the environment.

All these factors achieve a better implant-bone bond, with greater retention strength and greater stability, optimizing the osseointegration process and attaining clinical success and rehabilitation survival.

MACRODESIGN

The BNT® implant system is designed to simplify clinical and laboratory processes by means of its standardized connection. This concept of simplification, together with the research and development of the AVANTBLAST® surface combined with the implant’s self-tapping aims to:

Make implant insertion easier.

Achieve greater contact surface.

Create constant biomechanical stimulus.

Achieve the maximum primary stability possible as of insertion.

Reduce temperature generated during implant insertion.

Provide maximum prosthesis versatility.

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PURPOSE OF THE IMPLANTS

The goal of BNT® implants is the recovery of masticatory, esthetic and phonation functions, replacing lost teeth in the mandible or maxilla through the surgical implantation of dental implants in the remaining bone tissue, and the rehabilitation of the various functions through suitable prostheses.

IMPLANT DIAMETER

BNT® implant system consists of four self-tapping implants manufactured in pure Titanium Grade 2.

IMPLANT SERIES 2: Body diameter 3.3mm, internal metric 1.8mm, available in various lengths.IMPLANT SERIES 3: Body diameter 3.6mm, internal metric 2.0mm, available in various lengths.IMPLANT SERIES 4: Body diameter 4.2mm, internal metric 2.0mm, available in various lengths.IMPLANT SERIES 5: Body diameter 4.8mm, internal metric 2.0mm, available in various lengths.

STANDARDIZED IMPLANT CONNECTION

The BNT® implant has various shoulder diameters with external hexagon that pro-vide the anti-tapping characteristic of the prosthetic elements fixed to the implant via retention of the prosthesis’ definite screw. Hexagon platforms and heights for each series are:

IMPLANT SERIES 2:Shoulder diameter 3.3mm, hexagon height 1.0mm.IMPLANT SERIES 3:Shoulder diameter 4.0mm, hexagon height 0.7mm.IMPLANT SERIES 4:Shoulder diameter 4.0mm, hexagon height 0.7mm.IMPLANT SERIES 5: Shoulder diameter 5.0mm, hexagon height 1.0mm.

SELF-TAPPING PROFILE

The BNT® implant is self-tapping. The main advantages of the outer thread design are: minimally invasive and directional to facilitate implant insertion and shorten surgical times; reduced bone temperature increase during implant insertion, biomechanical stimulus of the bone tissue and maximum implant stability after its insertion.

The contra-angle bone tap and apical zone design, with the progressive nucleus of the implant shoulder, offers the great implant primary stability necessary for treatment success as a result.

The excellent chewing load distribution makes stimulating bone repair and subse-quent maintenance easier.

MICROTHREADS

The design of the implant neck includes a series of microthreads that distribute the forces in the implant insertion phase.

The critical point of the bone-implant interface is located in cortical bone, where the highest stress values are observed. The microthreads reduce this stress, favo-ring implant insertion and improving primary stability.

The implant is equipped with 2.5 mm of processed microthreads that extend to its most coronal portion, corresponding to the point of contact with the bone crest. In the 6 and 7 mm implants the thread height is 1.66 mm.

These microthreads:

Facilitate implant insertion

Reduce cortical stress at the time of insertion

Increase the bone / implant contact surface

Ensure less marginal bone loss over the long term

HEXÁGONO EXTERNO HOMBRO

3.3 mm

3.3 mm 3.6 mm 4.2 mm 4.8 mm

4.0 mm 4.0 mm 5.0 mm

PLATFORM PLATFORM PLATFORM PLATFORM

BODYBODYBODYBODY

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CONTRAINDICATIONS:

· 10.0mm long implants are contraindicated in bone with bone quality type III or IV for bearing a unitary crown.

SPECIFIC INDICATIONS WITH PROPER WIDTH, HEIGHT AND BONE QUALITIES:

· Indicated in fixed unitary and multiple rehabilitations by the replacement of natural roots and support of crown of the lateral superior incisors, inferior premolars and second superior premolars.

· Indicated in the rehabilitation of total edentate patients by an overdenture supported by 4 or 6 implants in the antero-superior area and 4 implants in antero- inferior area, splinted by means of a rigid metallic structure.

Combining series 3 implants with series 4 implants, depending on bone area and load strength, bone quality and type of arch antagonist, is recommended.

CONTRAINDICATIONS:


BNT® IMPLANT INSERTION SPECIFICATIONS

DEFCON BNT® implants are not to be used when there are medical contraindi-cations. In general, the use of implants in the maxilla and jaw are not indicated for unitary load, when there is a discrepancy between the superficial area of the implant and the size of the crown to be replaced.Insertion specifications described in this procedure for every BNT® implant series are based on the type of dental root surface to be replaced and on the mean size, surface, and functional chewing loads of the natural crown to be borne.

INSERTION HEIGHT 1.2

We recommend final insertion of the BNT® implant at supracrestal level, the entire AVANTBLAST® surface being protected by bone, and leaving 0.7 mm of untrea-ted surface for soft tissue attachment – favoring the formation of biological space that is essential for the preservation of crest bone and the final esthetic outcome.

Implant characteristics: 1.3· AVANTBLAST® surface· External connection offering the following advantages:· Antirotary retention· Maximum prosthesis versatility

CLINICAL INDICATIONS

o Post-extraction implantation with or without regenerationo Implantation in healed socket with or without regenerationo Implantation for all types of bone and sectorso Implantation indicated for all surgical areas

HEXAGON

HEIGHT

1.0mm

PLATFORM

PLATFORM

MAXILLARY

MAXILLARY

MANDIBULAR

MANDIBULAR

HEXAGON

HEIGHT

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SPECIFIC INDICATIONS WITH

PROPER WIDTH, HEIGHT AND BONE QUALITIES:

· Indicated in fixed unitary and multiple rehabilitations by the replacement of natural roots and support of the crown of the central superior incisors, canines and premolars both in jaw and maxillary.

· Indicated in the rehabilitation of total edentate patients by an overdenture supported by 4 or 6 implants in the antero-superior area and 2 or 4 implants in antero-inferior area, splinted by means of a rigid metallic structure.

· Indicated in cases of first inferior and superior molars of reduced size, series 4 implants can be used if there is no situation that contraindicates it.

CONTRAINDICATIONS:


SPECIFIC INDICATIONS WITH PROPER WIDTH, HEIGHT AND BONE QUALITIES:

· Indicated in fixed unitary and multiple rehabilitations by the replacement of natural roots and support of molars’ crown both in jaw and maxillary.

CONTRAINDICATIONS:


Product design, performance and treatment success are based on the indica-tions set forth above. All products not complying with the described indications or clinical cases with insufficient bone, clinical cases involving advanced surgery, biomaterial incorporation, sinus elevations, bone fillings, advanced surgical techni-ques, and lack of parallelism between implants, among other factors, are not under guarantee.

IMPORTANT:

Implant insert ion outs ide the range of these speci f icat ions can cause severe harm to pat ient ’s heal th.

DISTANCIA MÍNIMA ACONSEJADA ENTRA PIEZAS DENTALES E IMPLANTES DE DIFERENTE SERIE . POR NORMA GENERAL SE ACONSEJA UNA DIS-TANCIA MÍNIMA DE 3 MM ENTRE DOS IMPLANTES ADYACENTES Y 1.5 MM ENTRE UN IMPLANTE Y UNA PIEZA DENTAL CON EL FIN DE PRESERVAR LA VASCULARIZACIÓN ÓSEA

HEXAGON

HEIGHT

PLATFORM

MAXILLARY

MANDIBULAR

MAXILLARY

MANDIBULAR

HEXAGON

HEIGHT

PLATFORM

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ACCESSORY OPTIONS ACCORDING TO PROSTHODONTIC REHABILITATION

* En la se lecc ión de los p i la res se debe tener en cuenta: E l hombro de l implante/d iámetro, espac io in teroc lusa l , espac io in terdenta l , d ispara le l ismos y rehabi l i tac ión prostodónt ica p lan i f icada.

SCREWED

SINGLE

MULTIPLE

OVERDENTURES

UCLA HEXED CASTING CYLINDER

HEXED ABUTMENT POST

INVERTED TAPER ABUTMENT

CEMENTED

SCREWED

SCREWED

ANGLED ABUTMENTS 15º 25º WITH SCREW

UCLA NON-HEXED CASTING CYLINDER

UCLA NON-HEXED CASTING CYLINDER

BALL ABUTMENT

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TREATMENT PLANNING

The purpose of dental implant treatments is to restore the functionality of lost natural teeth.

The cornerstone for achieving the treatment goals is treatment planning by means of prosthodontic rehabilitation. For this purpose it is necessary to use the clinical history, clinical-radiological diagnosis, examination, and study models, among other things, according to general regulations and protocols applicable to implantology.

Surgical technique

Defcon Tissue Care® recommends a three-dimensional study (CAT) and the use of surgical splints to ensure correct positioning of the implants in all three spatial dimensions (apico-coronal, mesio-distal or vestibulo-lingual or palatine).

The CAT scan also allows us to establish bone quality – this being an important factor for the drilling technique.

The following general information should be obtained in order to carry out the treatment:

· Clinical history, Overall: Personal and family medical history, Overall health status Specific: Health status of mouth and teeth.· Clinical and radiological examination.· Registering of the anatomical status through study models.· Diagnosis and treatment plan.· Patient’s expectations.· Possible contraindications.

GENERIC CONTRAINDICATIONS:

RELATIVE:

Age, stress, smoking, pregnancy, bone deficiency, alcoholism, drug abuse, lack of oral hygiene, periodontal diseases, and addictions in general, among others.

ABSOLUTE:

Endocrine (decompensated diabetes mellitus, hyperparathyroidism), blood dyscra-sias for which surgical therapies are contraindicated, cardiovascular and/or end-stage conditions, infectious diseases, radiation therapy, corticotherapy and anticoa-gulant therapy, epilepsy and psychological factors.

Data collected jointly with clinical examinations permit making a clinical

diagnosis and the designing of the prosthodontic rehabilitation.

To confirm the initial diagnosis, impressions are made to obtain study models by mounting them in a semi-adjustable articulator guided by the bite record. This allows for the determination of edentate areas and the dimensions of the available space, patient’s occlusion, type of arch antagonist to the area to be rehabilitated.

DEFCON® BNT ®. RADIOLOGICAL TEMPLATE SCALES 1:1 - 1.25:1-1.30:1

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Reconstruction waxing is made establishing the dimensions and design of the future prosthesis. The wax-up allows for making a temporary repair and constructing sur-gical guides to locate implants and prosthodontic rehabilitations necessary for their insertion. DEFCON Tissue Care® system

includes Open Guide® guides for surgical splint insertion.

An advantage of the titanium guide design is the vestibular opening, facilitating the access of the initial surgical drills and osteotomy visualization. (Fig.2).

Clinical, radiological and model examinations are basic tools for defining the type of rehabilitation needed for patients to recover their anatomical structures, chewing function and esthetics. A treatment plan is drawn up including rehabilitation plan-ning over time, type of prosthesis, number of necessary implants as support of the prosthesis type, and implant position level in relation to bone crest and soft tissue, among other things.

Treatment planning is paramount to safeguard biological structures. The goals of this are: foreseeing the load along the implant transversal axis, avoiding extension elements, management of transversal loads, stability control, occlusion and control of hygiene and parafunctions stimulating bone anchoring with the incorporation of a number of implants of length and diameter that fit the anatomical situation, permit-ting a counterbalance of forces acting on different levels.

FIG. 2 OPEN GUIDE® GUIDE AND SURGICAL SPLINT

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INSTRUMENTS AND SURGICAL TRAY

The surgical tray is supplied unsterilized.

The surgical tray design offers solid ergonomics in the surgical field. It consists of a base, a tray where the surgical instruments are placed, and a cover.

Before surgery it is necessary to clean each and every one of the components of the tray separately, paying close attention to

hard-to-reach areas.

The detergents used as chemical cleaners on their own cannot eliminate all the dirt and/or waste, therefore it is essential to clean carefully by hand with an sponge or a soft cloth to remove most of the material adhered following surgeries.

A clean soft bristle brush is recommended for hard-to-reach areas. Solvents, abrasi-ve cleaners, metalic brushes or abrasive pads should not be used.

A soft, neutral pH, enzymatic detergent is recommended.

Additionally, surgical trays may be mechanically cleaned in an ultrasonic cleaner.

Prior to use, check that all surgical tray components are clean and free of damage.

Do not introduce any instrument other than the one indicated so as to avoid over-loads or the inappropriate entry of water vapor through the holes.

It is important to make clear that surgical drills are indicated for a maximum of ten (10) uses. Their maintenance, accurate disinfection and cleaning, protection from strikes, and lack of residue deposits thereon favor maintenance and cutting speci-fications. Poor cleaning and maintenance decrease drill use and cuts and may lead to the failure of the implant treatment.

DUAL FUNCTION TORQUE WRENCH

DEFCON Tissue Care® system torque wrench has a dual function as torque control and as torque wrench proper (Fig. 1).

The torque wrench is supplied unsterilized. It is important to disinfect and clean torque wrenches prior to their use. At the lower part of the torque wrench it is pos-sible to regulate the recommended torque for implant insertion or positioning and fastening of definitive prostheses (Fig.2).

The torque to be used is set on the torque wrench. When the torque wrench exerts forces in relation to the established torque, it bends on the upper part or head, indi-cating that the established force has been reached (Fig 3).

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PREPARING THE SURGICAL FIELD

The preparation of the surgical field, as well as cleaning, disinfection and sterilization processes in implantology instruments, components and equipment is based on hygiene and patient safety procedures as found in general regulations and protocols applied in dentistry practices.

Below we provide a summary detailing part of these standard protocols with the specific indications for the DEFCON Tissue Care® implant system.

The surgical field should be under aseptic conditions before and during the surgical intervention.

General aspects of surgical field preparation involve such things as:

· The patient’s clinical record, technical information and treatment plan.

· Sterilized DEFCON Tissue Care® implant system instruments.

· Sterilized instruments, components and generic equipment for surgery.

· Surgical table protected by sterile drapes.

· Positioning all instruments visibly and in the order of use on the surgical table, bearing in mind surgical procedures.

· Protection of operating room equipment and components with sterile towels.

· Surgical engine with new irrigation hoses.

· Patient preparation for surgery. Mouthwash, cleaning and disinfection of the sur-gical area.

· The staff should be equipped with the specific surgical apparel for this purpose, such as surgical gown, mask, sterile disposable gloves, protective plastic goggles and suitable shoes, among other things. In addition they are to wash and disinfect their arms and hands according to the standard protocol.

It is important to mention that during the surgery a sterile package with normal saline should be available for the placement of the instruments used, such as surgical drills, scalpel blades, torque wrenches, adapters, etc., in order to avoid strikes and deposits on the instrument surface.

STANDARD PROCESS FOR CLEANING, DISINFECTING AND STERILIZING DEFCON® INSTRUMENTS

Cleaning, disinfection and sterilization processes, as well as surgical field prepara-tion, are based on the hygiene and patient safety procedures set forth in general standards and protocols applied in dentistry practices.

Below we provide a summary detailing part of these standard protocols with the specific indications applicable to them from the DEFCON Tissue Care® implant sys-tem.

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The usual cleaning, disinfection and sterilization process begins by removing the instruments from the package with normal saline used during the surgery.

MANUAL CLEANING

Following that, instruments should be carefully cleaned of any organic remains prior to their disinfection and sterilization. Cleaning is preferably done with a white bristle brush and plenty of water throughout the process in order to eliminate any organic remains deposited on the instrument surface.

MECHANICAL CLEANING

Once manual cleaning is complete, mechanical cleaning will be carried out with ultrasonic cleaner for the detachment of hard-to-see or hard-to-reach particles.

It is important to use descaling products or detergents specific for this process, strictly following the manufacturer’s instructions for use with respect to time, tempe-rature and concentrations.

DISINFECTION

Disinfection should be cold disinfection, in a container with specific products for said purpose.

Do not use peroxide, strong acids or products with high chlorine content; only pro-ducts whose pH is between 5 and 9 are appropriate. Manufacturer’s instructions for use with respect to time, temperature and concentrations should be strictly fo-llowed.

IMPORTANT:

Failure to comply with the indications given by manufacturers of the products used in the procedures described above can lead to serious damage to material, such as instrument rusting, loss of surgical drill sharpness and life-span; in addition, there are complications in the subsequent surgery, producing bone overheating/necrosis and lack of implant osteointegration.

STERILIZATION

Sterilization is carried out by autoclave in an ordinary sterilization cycle at a maximum of 135º C for a minimum of 6 minutes. Dry heat sterilizers should not be used since they would directly affect sharpness and other features of surgical instruments. Do not remove the material from the autoclave before the drying cycle is complete.

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IMPLANT INSERTION

INCISION

Implants can be placed with mucoperiosteal incision and flap raising to allow direct visualization of the bone; alternatively, they can be placed without a mucoperiosteal incision, using a circular scalpel. Use of the circular scalpel requires the existence of adequate keratinized gingival tissue and prior three-di-mensional planning of the treatment, to precisely determine the amount of bone. IMPORTANT, PRIOR TO INSERTION.

The preparation of the bone bed requires the use of special, sharp instruments under constant irrigation, with completion of the specific surgical sequence for the insertion of each implant indicated in that surgical procedure and with the speeds recommended therein. Failure to do so may result in the use of excessive force in implant insertion (greater than 50Ncm), exceeding bone resistance, causing dama-ge to the implant and its connection, cold welding of the implant with the mount, implant fracture, necrosis and bone fracture,among other things.

PREPARACIÓN DEL LECHO ÓSEO

BNT® implant is designed to be placed at bone crest level. Implant length is defined as the distance from the maximum shoulder diameter to the implant apex or base (Fig. 1).

Bone bed preparation is carried out with an initial surgical sequence common to all series and a final surgical sequence specific for each implant series.

During surgical preparation of the implant bone bed, the following should be kept in mind:

· Use plenty of external refrigeration with sterile water solution or NaCl solution, pre-cooled at 5º C.

· Apply soft and intermittent pressure to the bone.

CONSIDERATIONS

During the preparation of full length bone beds in all implant diameters, apply mini-mum pressure at the end of the preparation, increasing the intervals between these and removing the bit from within the duct being prepared in order to allow for blee-ding, decrease of local pressure and cooling, thus avoiding bone overheating and necrosis.

It is important to remove drilling residues by means of irrigation with syringe and sterile solution at the end of the surgical sequence.

Surgical drills are indicated for a maximum of 10 uses. Exceeding the number of indicated uses affects the success of the implantological treatment.

Recommended turning speeds for drilling, depending on drill diameter, are specified in the attached chart.

13.75 mm

12.25 mm

10.75 mm

7.75 mm

9.25 mm

5.25 mm

6.25 mm

DESCRIPTIONDIAMETER

CIRCULAR SCALPEL

ROUND MARKING BURS

ROUND MARKING BURS

PRECISION DRILL

INITIAL HELICAL DRILL

BNT® SERIES 2 FINAL HELICAL DRILL


BNT® SERIE 4 INTERMEDIATE HELICAL DRILL


CONTRA-ANGLE BONE TAP

RECOMMENDED TURNING SPEEDS

CRESTAL INSERTION

IMPLANT LENGHT

BONE CREST LEVEL

CRESTAL INSERTION

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INITIAL SURGICAL SEQUENCE SIN INSICIÓN DE COLGAJO

Once the incision is made, the flap lifted and the bone crest uncovered, the surgical splint is positioned with the Open Guide® guides already incorporated to the splint, making the drilling and the direction of the vestibulo - palatino/lingual axis easier. In the cases of narrow bone crests, their regularization is recommended to increase the vestibulo-lingual/palatine width, leaving enough bone margin following placement of the implant.

INITIAL SURGICAL SEQUENCE / ROUND MARKING BUR.

The initial sequence begins with a Ø1.8mm round marking bur, with a turning speed of 850rpm, inserting through the surgical splint guide and marking the bone crest (Fig.1).

After marking with the Ø1.8mm round marking bur, a Ø2.3mm round marking bur at a turning speed of 850 rpm is used to mark and increase the diameter in the bone crest, centralizing the axis for the next osteotomy (Fig.2).

It is deepened with the Ø2.3mm round marking bur, piercing the cortical bone.

INITIAL SURGICAL SEQUENCE / PRECISION DRILL.

The initial sequence begins with an Ø2.3mm precision drill, with a turning speed of 850 rpm, inserting it through the surgical splint guide surpassing the cortical bone and centralizing the axis for the next osteotomy. (Fig.3).

After that, the Ø2.3mm helical drill is used at a turning speed of 850 rpm until the programmed length is attained, exerting mild and intermittent pressure.

The use of a precision drill is recommended in clinical cases where the diagnosis permits surgery without lifting the soft tissue flap.

DRILLING LENGTH

Once the cortical bone is passed, the initial Ø2.3mm helical drill is used at a turning speed of 850 rpm until the programmed length is attained, exerting a mild and inter-mittent pressure, with the purpose of avoiding bone overheating (Fig.4).

Following that, the depth indicator drill/parallelizer is inserted to check drilling length and parallelism; at this point corrections may be made for the next.(Fig.5).

IMPORTANT:

Abundant irrigation is necessary in all osteotomies and procedures until implant in-sertion.

ROUND MARKING BURS

PRECISION DRILL

*All helical drills in the DEFCON Tissue Care® system are available in two measu-res, short and long, depending on the available space and insertion areas, except for helical drills in Series 5, designed in one length only.

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TSH® SERIE 2 FINAL SURGICAL SEQUENCE

Once the initial sequence is completed for all series, the final osteotomy sequence begins for the BNT® Series 2 implant. The diameters of the shoulder, body and the remaining BNT® implant specifications are described at the beginning of this procedure.

The final osteotomy for BNT® Series 2 implant is made with Ø2.8mm helical drill at a turning speed of 750 rpm until the programmed length, exerting mild and in-termittent pressure (Fig6). The Series 2 Ø2.8mm depth indicator drill is inserted to check whether the total length drilled corresponds to the programmed drilling length (Fig.7). Passing dental floss through the depth indicator orifice is recommended to avoid that the indicator is swallowed by the patient.

In case of bone quality type I or II, in thick cortical and anterior maxillary and man-dibular regions, tap threading of the implant in the bone bed is carried out with the Series 2 contra-angle bone tap at a turning speed of 15 rpm in the case of contra-angle (Fig. 8).

IMPORTANT:

Abundant irrigation is necessary in all osteotomies and procedures until implant in-sertion is achieved.

FIG.10

* The helicoidal drills of the DEFCON Tissue Care® system are available in two lengths, short and long, depending on the available space and insertion areas, except the helicoidal drills for Series 5, designed in only one length.

DENTAL FLOSS

CONTRA-ANGLE BONE TAP BONE QUALITY TYPE I AND II

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TSH® SERIE 3 FINAL SURGICAL SEQUENCE

Once the final surgical sequence of Series 2 is completed, the final surgical sequen-ce for Series 3 BNT® implant is started. Shoulder diameters, body and other BNT® implant specifications are determined at the beginning of this procedure.

The final osteotomy for BNT® Series 3 implant is made with Ø3.0mm helical drill at a turning speed of 750 rpm until the programmed length, exerting mild and in-termittent pressure (Fig.9). The Series 3 Ø3.0mm depth indicator drill is inserted to check whether the total length drilled corresponds to the programmed drilling length (Fig.10). Passing dental floss through the depth indicator orifice is recommended to avoid that the indicator is swallowed by the patient.

In case of bone quality type I or II, in thick cortical and anterior maxillary and man-dibular regions, tap threading of the implant in the bone bed is carried out with the Series 3 contra-angle bone tap at a turning speed of 15 rpm in the case of contra-angle (Fig. 11).

IMPORTANT:

Abundant irrigation is necessary in all osteotomies and procedures until implant in-sertion is achieved.

FIG.11

FIG.12

FIG.13

* The helicoidal drills of the DEFCON Tissue Care® system are available in two lengths, short and long, depending on the available space and insertion areas, except the helicoidal drills for Series 5, designed in only one length.


DENTAL FLOSS

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TSH® SERIES 4 FINAL SURGICAL SEQUENCE

Once the final surgical sequence of Series 3 is completed, the final surgical se-quence for Series 4 BNT® implant is started. Shoulder diameters, body and other BNT®implant specifications are determined at the beginning of this procedure.

The final osteotomy for BNT® Series 4 implant is made with Ø3.6mm helical drill at a turning speed of 650 rpm to the programmed length, exerting mild and intermittent pressure (Fig.12). The Series 4 Ø3.6mm depth indicator drill is inserted to check whether the total length drilled corresponds to the programmed drilling length (Fig. 13). Passing dental floss through the depth indicator orifice is recommended to avoid that the indicator is swallowed by the patient.

In case of bone quality type I or II, in thick cortical, maxillary and mandibular regions, tap threading of the implant in the bone bed is carried out with the contra-angle bone tap of Series 4 at a turning speed of 15 rpm in the case of contra-angle use (Fig 14).

IMPORTANT:


* Every helicoidal drill of the DEFCON Tissue Care® system is available in two leng-ths, short and long, depending on the available space and insertion areas, except for the helicoidal drills for Series 5, designed in only one length.

FIG.11

FIG.12

FIG.13

DENTAL FLOSS


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TSH® SERIES 5 FINAL SURGICAL SEQUENCE

Once the final surgical sequence of Series 4 is completed, the final surgical sequen-ce for BNT® implant of Series 5 is begun. Shoulder diameters, body and other BNT® implant specifications are determined at the outset of this procedure.

The final osteotomy for BNT® Series 5 implant is made with Ø4.1 mm helical drill at a turning speed of 550 rpm to the programmed length, exerting mild and intermittent pressure. (Fig. 15). The Series 5 Ø4.1 mm depth indicator drill is inserted to check whether the total length drilled corresponds to the programmed drilling length (Fig. 16). Passing dental floss through the depth indicator orifice is recommended to avoid that the indicator is swallowed by the patient.

In case of bone quality type I or II, in thick cortical, maxillary and mandibular regions, tap threading of the implant in the bone bed is carried out with the contra-angle bone tap of Series 5 at a turning speed of 15 rpm in the case of contra-angle use (Fig 17).

IMPORTANT:


* Series 5 helicoidal drills of the DEFCON Tissue Care® system are available in only one length.

FIG.11

FIG.12

FIG.13


DENTAL FLOSS

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DEFCON® IMPLANT PACKAGE AND LABEL

DOUBLE BLISTER PACKAGING

DEFCON TISSUE CARE® IMPLANTS ARE PACKAGED BY UNIT.

IMPLANT PACKAGING

IMPORTANT:

The purpose of the ID labels on each implant is to ensure the traceability and warranty of the product used in each patient. Place labels on: patient’s history and record; laboratory fact sheet related to the clinic and patient; finally, place label on any procedure that should be identified in relation with the patient’s treatment.

SYMBOLS FOR LABELLING CODES

See instructions for use.

Do not reuse.

Expiration date

Caution, see attached documents.

Product lot Nº

Radiation sterilization

Product reference

Three adhesive labels to place on the patient’s fact sheet, for maintaining traceability and guarantees.

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OPENING THE PACKAGING

Prior to opening the packaging, perform a visual check to ensure there is no dama-ge and that the pack is not broken, torn or otherwise damaged. Moreover, before opening, check that the data included in the implant’s label correspond to the pro-grammed diameter and length. The expiration date should also be checked prior to opening the container. Implants are provided sterile via use of 25Kgy Gamma radiation.

DEFCON Tissue Care® system implants are packaged by unit.

Implant packaging is characterized by:

· Outer cardboard box for each implant series.

. ID label, including a triple adhesive label for traceability and warranty preservation.

· Package insert inside the cardboard box.

· Double blister package, sealed with Tyvek, ensuring implant sterility. (Fig.1).

· Outer blister packagig. This contains the inner packaging. Upon opening, the inner packaging should be placed in the surgical field to preserve sterility. (Fig.2).

· Inner blister packaging. It contains the implant with its mount and the locking screw. (Fig. 3).

To open the outer cardboard box, press the spot labeled “Press” on the die-cutting area to release the double blister packaging and the packaging insert.

Once the external cardboard box is opened, it is important to see the indications printed on the Tyvek (Fig.1) to correctly open the external blister. When handling the outer box and opening the inner packaging, care should be taken to avoid sterile field contamination; therefore, staff outside the surgical field should handle these elements in order to maintain asepsis and sterility.

The internal container should be opened carefully, after the final osteotomy, following the indications printed on the Tyvek, and placing the container in the surgical field (Fig. 3). A quick or excessively forceful opening of the tyvek may cause the uncon-trolled release of the locking screw from the blister.

ATTENTION:

If the planned surgery is ultimately not performed due to reasons beyond your con-trol, the internal blister that carries the implant cannot be stored, kept or used for another surgery. The internal blister does not maintain implant sterility.

Implant sterility is guaranteed before the external blister is opened. The inner blister does not maintain the necessary conditions to preserve sterility.

Open the internal blister in the surgical field, immediately thereafter take the implant out of its place and, subsequently, remove the closing screw. (Figs.4 and 5).

Implant fixation in the internal blister is done by friction between the mounter and the area of the blister designed for that purpose (Fig.4). It is important to properly place the adaptors to the mounter and ensure that they are correctly fixed in order to move on to completely safe implant removal and transportation to the bone bed. If the implant is dropped and sterility is compromised, the handling, cleaning, sterilization and use of said implant on the patient is absolutely forbidden.

OPENING OUTER BLISTER

OPENING INNER BLISTER IN THE SURGICAL FIELD

INNER BLISTER CONTAINING THE IMPLANT AND THE

LOCKING SCREW.

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IMPLANT REMOVAL FROM BLISTER

IMPORTANT:

Prior to removing the implant from the blister and inserting it into the bone bed, the contra-angle torque and torque wrench should be adjusted to a maximum pair of 35 Ncm.

Manual or mechanical implant insertion should not exceed 35 Ncm torque; if this force is exceeded, it may cause significant or irreversible damage to the implant and on patient’s health.

The signs of excessive force when inserting an implant and the usual associated consequences include:

· Increased mount screw-to-mount fixation.· Excessive mount torsion leading to a cold welding between mount and implant.· Breaking of the mount screw or implant hexagon.

· Noticeable or unnoticeable damage to the implant connection, leading to short- or mid-term post-rehabilitation implant fractures or incomplete adjustment of prosthesis to implant connection.

· Damage to the inner implant tap, leading to faults in the definite prosthesis screws, screw breaking or loss of inner implant tap.

Potential causes:

· Final osteotomy sequence using a surgical drill with a diameter below indicated size.

· Final drilling sequence and implant insertion in type I and II bone quality, without performing the tap shaping process using the contra-angle bone tap, or implant shoulder shaping process in cases of crestal implant insertion.

· Defective cut of the surgical drills, among others.

IMPLANT MECHANICAL EXTRACTION FROM BLISTER

Once the mechanical adaptor is connected to the contra-angle (Fig.1), the mounter is inserted (Fig.2) until a slight friction and a click are noted when the adaptor is connected. (Fig.3).

Firmly grab the blister and set the contra-angle going at a turning speed of 15 rpm. Next, gently perform the extraction movement, separating the implant from the blis-ter. (Fig.4).

IMPLANT MANUAL EXTRACTION FROM BLISTER

After connecting the manual adapter to the torque wrench, it is inserted in the mount until a slight friction and a click are noticed when the adapter is connected.

Gripping firmly, take the blister and gently perform the extraction movement, sepa-rating the implant from the blister.

CLICK RETENTION AREA

EXAMPLE OF MECHANICAL EXTRACTION

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IMPLANT INSERTION

GENERAL CONSIDERATIONS

With bone quality type I and II, it is necessary to make some intermittent short stops during the implant insertion, especially when inserting implants of greater length and diameter. Irrigation will continue throughout the insertion.

Once the final drilling sequence is completed, it is necessary to check that bleeding is not excessive and to check bone bed vascularization, as well as to confirm that there is no sharp bone projection that may interfere with implant insertion or with subsequent soft tissue handling.

Before inserting the implant and after the final drilling sequence, it is important to check that the length matches the planned length using a depth indicator and to confirm that the bone bed is free of any drilling debris.

PRIMARY STABILITY

Various factors such as bone charcateristics, bone quantity and quality, implant lo-cation and preparation technique, among others, will directly affect the degree of stability.

MECHANICAL AND MANUAL INSERTION

In the case of mechanical insertion, a partial implant insertion is recommended (Fig.1), and then manual completion of the insertion using the torque wrench to position the implant at the desired length for a more direct appreciation of implant primary stability. (Fig.2).

It is important to proceed with implant insertion slowly, maintaining continuous irri-gation during insertion, with a maximum insertion torque of 35 Ncm and a turning speed of 15 rpm.

During implant insertion, the recommended forces should not be exceeded; no su-dden moves should be made during insertion, and the instruments should always be aligned with the bone bed axis to avoid inappropriate force or tension on the mount and implant.

EXAMPLE OF MECHANICAL INSERTION

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* Possibilty of screw extraction with the mechanical hex driver and manual extraction with torque wrench.

MOUNT DISMOUNTING

Once the implant is inserted, it is necessary to use the open-end wrench for the mount in order to minimize implant movement and maintain maximum stability du-ring the removal of the mount retentive screw (Fig. 1).

After positioning the open-end wrench, the manual or contra-angle hex driver is inserted in the retentive screw (Fig. 2). Retentive screw removal is carried out in a counterclockwise fashion (Fig. 3).

The mounters’ retentive screws are calibrated with a specifc torque, to be removed manually or mechanically without problems. Retentive screws stay in the hex driver by friction.

In those cases where forces are superior to those indicated above, it is possible that the retentive screw is more significantly fixed to the mounter and that the mounter becomes slightly blocked with the implant because of these elements’ friction and torque. In retentive screw extraction operations and later mounter extraction opera-tions, the use of the open end wrench is recommended, making small countercloc-kwise movements in order to unblock the components (Fig.4).

Next, the mounter is removed by means of “mosquito” pliers (Fig.5).

Then, and depending on the planned treatment, surgery is completed using the chosen procedure (see next page), after cleaning the area and the implant using nor-mal saline, and removing particles and debris from the osteotomy that may interfere with the collocation of the components and accessories.

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PROCEDURES WITH DEFCON TISSUE CARE®

To complete the surgery, and depending on the planned treatment, the DEFCON Tissue Care® implant system includes different methods.

It is necessary to check the prosthodontic procedures of the DEFCON Tissue Care® system in order to have complete and updated information regarding the procedures to be applied in the planned treatment . The different options for finishing surgery are:

ONE-STAGE SURGERY

This procedure is indicated for mid-to-high bone density and quality, with com-promise of implant primary and secondary stability with respect to the type of rehabilitation planned.

The minimum recommended waiting periods and times prior to rehabilitation are 6-8 weeks. The advantages of this procedure are:

· Minimal soft tissue manipulation, preserving the epithelial adhesion structure, with no subsequent manipulation of the abutments.· Improved esthetic results for the patient during waiting periods.· Simple and quick procedures.· Reduction in the number of clinical procedures and rehabilitation time compared with two-stage surgery.

The implant shoulder stays in contact with the oral medium during bone and soft tissue repair stages by means of the healing abutment, around which the suture is made.

TWO-STAGE SURGERY. DELAYED FUNCTION.

This procedure is indicated for clinical cases in which any kind of force or load transfer to the implant must be avoided and when there is low cortical and trabe-cular bone density and quality, which compromises implant stability in terms of the planned rehabilitation type.

The minimum recommended waiting periods and times prior to rehabilitation are 12-24 weeks.

The implant shoulder and the closing screw are covered by soft tissue without co-ming into contact with the oral medium.

In a second stage, the soft tissue that surrounds the healing abutment will be mo-deled.

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PROCEDURE CONSIDERATIONS

The abovementioned procedures are recommended under optimal clinical situations and with optimal bone status.

The mean time for implant osseointegration mentioned for each procedure varies depending on factors such as insufficient bone, clinical cases requiring complica-ted surgeries and techniques, biomaterial application, sinus elevation, bone filling, lack of parallelism between implants, in addition to the implant diameter and leng-th, insertion area, planned prosthodontic rehabilitation, margin height and tissue, cortical space, interdental distance and esthetic compromise, among others. MAINTENANCE AND POST-OPERATIVE CONTROL

After the surgery, it is recommended that one administer ice bags to the patient and establish an antibiotic regimen with different agents and an oral hygiene protocol.

It is important to perform post-operative follow-up and control, with radiological as-sessment and regular check-ups based on general regulations and protocols appli-cable to implantology.

Surgical and prosthetic procedures are available from our website or your distribu-tor.

This leaflet was revised and approved in 2010-03-22.

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SURGICAL PROCEDURE - Phibo® · The use and application of DEFCON Tissue Care® dental implant...

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