For Peer ReviewImplant-retained mandibular overdenture with 3 Bränemark MKIII

implants : a clinical comparative study between delayed and immediate loading

Journal: Journal of Clinical Periodontology

Manuscript ID: draft

Manuscript Type: Original Article Implant Dentistry

Date Submitted by the Author:

n/a

Complete List of Authors: GREGORY, STEPHAN; Clinique Gaston Berger, Implantology paul, mariani; Clinique Gaston Berger, Implantology Noharet, renaud; Clinique Gaston Berger, Implantology VIDOT, fabien; Clinique Gaston Berger, Implantology

Topic: Implantology

Keywords: immediate loading

Main Methodology: Clinical Trial

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Implant-retained mandibular overdenture with 3

Bränemark MKIII implants : a clinical comparative

study between delayed and immediate loading

STEPHAN G*., VIDOT F.**, NOHARET R. **, MARIANI P.***

Meshs : loading, immediate, implant

Abstract

The purpose of this clinical study was to compare the immediate loading and the classical

delayed loading procedures ob three Nobel MKIII implants under mandible overdenture.

Twenty-six patients received each three in the symphiseal area splinted with an gold bar. In

the test group (n=17), the three splinted implant were loaded two days after surgery ; in the

control group (n=9), the 3 implant were loaded 3 months after surgery with the classical two-

stage procedure. Visits were sheduled every 3 months during 2 years and the clinicals

parameters tested were as follow : health of peri-implant soft tissues was evaluated with

Modified Bleeding index (MBI), Modified plaque index (MPI), and pocket probing depth

(PPD), the peri-implant bone resorption measured with panoramics radiographs, implant

stability with RFA and patient’s satisfaction with a questionaire. After 2 years, no implant

failed in the both groups. No significant difference was found between the two groups at 24

months. Only a greater mean values of bone loss and pocket probing depth was found at 12

months in the control group. Questionnaire showed an increase of functionnal and

psychologic comfort with the implant-retained overdenture treatment.

The immediate loading of three connecting implants under a mandible overdenture shortens

the waiting period before prosthese placement apparently with comparable results as the

delayed procedure. Three implants reduce the cost of treatment and could interrest more

patients. But extended follow-up and inclusions observations will be necessary before this

protocol will being the standart procedure for edentulous people.

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The two implants-retained overdenture’s solution in mandible is actually considered as the

minimum treatment of edentulism because the high success, low cost and predictable

results27.

During 30 years, the two-stage protocol using unloaded and submerged implant have been

described to be necessary to obtain osseointegration1,2,3,9,11,12. The classical healing period of

submerged implant and without loading described initially within 3 to 6 months, was

empirical9,11,12.

Comparable results have been showed between two or single-stage procedure, for

osseointegration, bone resorption and success rate15,25,26,35,67,68,69. Futhermore, the waiting

period may cause some functional and psychologic disconfort to the patients due to the

instability of the conventional prosthese. Next step was to reduce waiting period between

surgery and prosthetic placement. But mechanical stress on implant during healing period

may cause fibrous tissues interposition between bone and implant surface if micromotions are

up to 150 microns13,14,71. Clinicals studies and case report showed that osseointegration

occured normally when implants were splinted by the mean of rigid connection. Framework

was like an orthopedic external fixator and permit to reduce motion32,33,34,35,40,57,64,65. Actually,

edentulous patients was successfully rehabilited with immediate or early-loading fixe or

removal prostheses.

Overdenture is an interesting solution for old patients because the low cost and the easy

clining. Four implants, splinted with a U-shaped Dolder bar, are usually used to stabilise

mandible overdenture in immediate loading studies16,17,18,30,31,59.

Malo and cowokers described the All-on-four method consisting in a fixed acrilic resin

prosthese without cantilever supported by 4 implants45. Cumulative success rate after 3 years

were 96,7% for implant and 100% for prosthese. Except Novum procedure10,24,36, 4 implants

seems to be the minimal implants number for fixed full-arch rehabilitation45.

Three implants under overdenture may presents some advantages : well for all bone crestal

form, low cost interesting more patients, and can be splinted with a gold bar to obtain tripod

configuration.

The aim of this clinical study was to compare the results between delayed and immediate

loading of three implant-retained mandibular overdentures.

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MATERIALS AND METHODS

Patients

Twenty-six patients with complete edentulism of the mandible, 13 females and 13 males, aged

between 43 and 78 years were treated during a 3-year period (January 2003- to October

2005). All patients were complete denture wearer and need implants to stabilize it. Each

patients have received 3 Nobel Biocare MKIII implants (Nobel Biocare AB, Göteborg,

Sweden) in the symphisis area. Patients selected for this study were healthly without systemic

disorders or treatment compromising implant surgery. All participents were informed about

the study and signed an informed consent. This study was approuved by ethic comity (Comité

Consultatif de Protection des Personnes dans le cadre de la Recherche Biomédicale

CCPPRB).

Inclusion criteria were as follows :

Mandible with full edentulism

Bone crestal volume enough to received standards implants (at least 10mm long and 3,75mm

in diameter)

Bone quantity level A,B,C,D or quality type 1,2,3 (Lekholm & Zarb classification41)

Criteria used for excluding patients were as follows :

Systemic desease (severe liver or renal deseases, uncontrolled diabetes, blood deseases,

mucosal deseases...)

Chemo or radiotherapy

Inadequate crestal bone for placement of implants (at least 10mm long and 3,75mm in

diameter)

Bone quantity level E or quality type 4(Lekholm & Zarb classification41)

Drug or alcohol abuse

Insufficient oral hygiene

Patients smockers or with bruxism were not excluded from the study.

Surgical protocol

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Radiographic template of mandible complete denture with a Gutta percha in the dental

medium site, was made. Bone anatomy of symphisis area was analysed on preoperative

tomodensitometric radiograph. Before surgery, all patients received a preventive antibiotics

treatment (Amoxicillin or Macrolid 2g/day, 1 day before and 7 days after surgery).

Seventy-height (3 per patient) Branemark system MKIII TiUnit implants (Nobel Biocare AB,

Göteborg, Sweden) were placed in the symphisis area. After local anesthesia (Primacaine®,

Pierre Rolland, Merignac, France), Gutta percha of template was removed and the medium

site was transgingiva drilled. Surgery started with an intraoral crestal incision with one or two

releasing buccal incisions (Fig.1). After subperiosteal dissection of the flaps, implants sites

were prepared with standard procedure under irrigation with sterile saline (Fig.2). Three

standard implants (3,75mm in diameter and 10mm long at least), were placed in symphisis

area of each patient (Fig.3).

After implant torque, treatment was different in the immediate and delayed loading groups.

In immediate loading group (experimental group), 3 multi-unit abutment (MUA) (Nobel

Biocare AB, Göteborg, Sweden) were immediately screwed to the implants at 35N.cm-1and

protected with healing caps. Flaps were sutured with classical technic (Ethicon, Somerville,

NJ, USA) (Fig.4).

In the delayed loadind group (control group), cover screw were placed ans implants were left

to heal during 2 months. In the second-stage surgery, after new crestal incision, 3 healing

abutments were screwed on implants. One month later 3 multi-unit abutments (MUA) (Nobel

Biocare AB, Göteborg, Suède) were connected in replacement of healing abutments.

In the both groups, sutures are removed 7 days after surgery.

Prosthetic protocol

In the experimental group (n =17), prosthetic procedure started immediately after suture of the

flaps. By the mean of three transferts coping screwed on multi-unit abutments MUA, an

impression with quick plaster (Protodont®, Laboratoire Van der Smissen, Golfe-Juan, France)

was obtain (Fig.5 and 6). One day after surgery, the gold bar was connected and passive fit

was controlled by using classical tests. A final impression by filling the mandible denture with

a polyether paste (Permadyne orange®, 3MEspe, Seefeld, Germany) under occlusal pression

permit to include the clips in laboratory (Fig.7 and 8). In this group, implants were immediate

loaded with an overdenture 48 hours after theirs placement.

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In the control group (n =9), prosthetic procedure was the same as test group, after multi-unit

abutment placement. In the control group, implants were loaded with the mandible complete

denture approximatively 3 months after surgery.

In the both groups, implant stability with RFA (OsstelTM, Integration Diagnostic Co,

Sweden) was mesured after fixture torque (Fig.7). No special diet was recommended for the

patients. Usually, balancal occlusion was used to optimize dental contacts. Standards oral

hygiene instructions were given.

Follow-up started 3 months later after surgery. During visits, scheduled at 3, 6, 12, 18, and 24

months, the gold bar was removed to recorded following parameters : modified Bleeding

Index (MBI, score 0-3)50, modified Plaque Index (MPI, score 0-3)50, peri-implant probing

depth (PIPD)50, were measured with a graduate explorer at 4 sites (mesiodistal, mesiobuccal,

distolingual and distobuccal) at 0, 6, 12, 18 and 24 months. Implant stability was evaluated for

each fixture at 0, 3, 6, 12, 18 and 24 months with RFA (OsstelTM, Integration Diagnostic Co,

Sweden). Peri-implant bone loss was evaluated at 0,12 and 24 months, on panoramic

radiographs. Distorsion of radiograph was corrected to compare real size of fixture and size

on radiographs. The mesial and distal bone level measured was computed with the

magnifiction coefficient obtain. Moreover patient’s opinion was investigated with a

questionnaire at 3 months. Six questions was asked to patients for comparison situations

before and after implant-retained overdenture : 1- general comfort (better, egal, worst); 2-

better eating (yes-no); 3- better speaking (yes-no); 4- better self-confiance (yes-no); 5- would

you do this treatment again (yes-no) ; 6- would you recommended this treatment to your

family or friends. The Chi-2 test serve to compare answers in the boths groups.

Data were analysed with SPSS version 10.1.3 (SPSS, Chicago, IL, USA). The U-test (Mann-

Withney) served to compare BI, PI, PIPD and ISQ between the two goups. The Student test

served to compare the peri-implant bone loss between the two groups.

RESULTS

Follow-up period was ranged between 6 and 40 months. A total of 78 implants in 26 patients

(13 females and 13 males) were loaded. No per or postsurgical complications were encounted.

Only 4 clip’s failure and 2 prostheses base failure occured and were easy repared. None

implant failed into the two groups. The cumulative success rate of implants in the both groups

after 2 years was 100%.

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After 2 years, all implants in the two groups presented a clinical stability. ISQ recorded were,

respectively for test and control groups, between 73,44 and 74,43 at the surgical day, 73,29

and 71,92 at 3 months, 72,35 and 72,92 at 6 months. Others values were detailled in table 1.

No statistical difference was found between the both groups at 0, 3, 6, 12, 18 or 24 months (p

>5%).

Modified Plaque index (MPI) and Modified Bleeding index (MBI) were recorded every 3

months during 2 years50. Medians and ranges of this boths clinical parameters were resumed

in Table 2 and 3. No statistical difference was found between the two groups at 0, 3, 6, 12, 18

or 24 months (p >5%). Means of Peri-implant probing depth index (PPDI) showed a

significant statistical difference between the two groups at 12 months (p >5%). Peri-implant

probing was greater in the delayed-loading group. But, no difference was found at 24 months

between the both groups (p >5%).

In the boths groups, bone loss means were conform to the limits described by Albrektsson et

al. The student test confirmed a significant difference of mean marginal bone resorption

between the immediate and delayed groups at 12 months (p >5%). Peri-implant bone loss

was greater in the reference group (Table 4 and 5). After 2 years, no difference was found

between the both groups (p >5%).

Patient satisfaction evaluated with a questionnaire demonstrated an improved of the life’s

quality (questions 1,4,5,6). All patients filled a significant improvement of chewing ability but

not for speaking (questions 2,3). The Chi-2 test wich served to compare responses, did’nt find

any significant difference between the two groups. Details are presented in Table 6.

DISCUSSION

In this study, our aim was to compare the short terms results of osseointegration and survival

of implants between immediate loading of 3 splinted Branemark TiUnit implant supporting an

mandible overdenture in comparison with the delayed method. Fixed or removal prostheses

supported by implants placed in the symphisis area with a two-stage procedure is well

documented. Linquist et al 1996 reported a cumulative survival rate (CSR) of 99% for

individual endosseous implant in the symphisis area, after a 15-years observation43. Only nine

patients were inclued in the control group, because results with the delayed procedure are

predictable5.

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In this study, no implant failed after 2 years and the cumulative survival rate was 100% in the

both groups. Mostly of comparative studies showed no significant difference between

immediate and delayed procedure16,17,18,28,30,31,37,59,72 in studies on 4 splinted implants under

overdenture, did’nt showed any difference between the delayed and immediate loading

procedure. The CSR of implant was within 97,5% to 96% after a minimal follow-up period of

2 years. Except the Novum method10,24,36, the all-on-four concept seems show that 4 implants

in the symphisis area appear to be sufficient for a full-arch rehabilitation45.

The main conclusion of the Mc Gill consensus statement affirmed that the minimal treatment

of mandible edentulism was now a two implant-retained overdenture27. Overdenture studies

with only 2 implants used in fact early-fonctionnal procedure55,56,61,70 in accordance with the

immediate loading definition19,20,21. Mostly of overdenture articles using an immediate

loading protocol (prosthese connection 1 or 2 days after surgery) described 4 splinted

implants under complete denture4,5,6,16,17,30,31,44,46,59,62,73. Three implants with a tripod

configuration is the minimal geometric configuration to reduce micromotion13,14,71.

Furthermore, this approach can adapt all crestal bone form.

Resonnance frequency analysis (RFA) was choosen in this study to evaluate implant stability

because it was more predictable than other system47,48. The mean RFA values did’nt differ

between the both groups during the 2-years follow-up. This values decreased during the first

12 months, then increased as described in others studies using RFA7,23,28,29,53,60,63.

Health of peri-implant soft tissues was evaluated with MPI, MBI and PIPD. Despite they are

rather imprecise, this parameters are currently use in clinicals studies8,16,17,30,31,42,,49,51,52,54,59,70.

In this our study, MBI and MPI’s results did’nt show difference between the two groups. The

only small difference, found at 1 year in the control group, seems show a greater bone

loss39,58,68.

The peri-implant loss was evaluated on panoramics radiographs because intraoral film were

difficult to use expecially in patient with advanced mandible crestal

resorption16,17,18,30,31,49,59,74,75. This method is criticizable because it be rather imprecise.

Despite this, the mean crestal bone resorption found at 1 year ( 0,05-0,42mm ) was in

accordance with the conventionnal values (0,2mm/year according to Albrektsson criteria3).

The greater bone loss in the delayed procedure group was probably due to the two surgical

stages. The only one-stage surgery seems cause less peri-implant bone resorption during the

first year. After two years, no difference was found between the both method. This results

differ of litterature results 16,17,30,31,59,70 wich showed no difference between the both protocols.

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In this study, the small number of inclusions wich limited the power of the statistical analysis

could explain the difference.

Questionnaire showed an improvement of functionnal and psychologic comfort with the

implant-retained overdenture treatment without difference between the two procedure. Fixed

prostheses are less mobile at mandible and showed better satisfaction score for eating hard

food. But no difference were found between fixed or removal prostheses wearing for speaking

or estheatic and almost 50% of patients prefered the implant-retained overdenture because it

was easier for oral hygiene22. In our study, chewing ability and general comfort increased in

accordance with litterature22,38,52,74.

CONCLUSION

Preliminary results of this prospective study seems show that 3 endosseous implants splinted

with a gold bar and supporting mandibular overdenture can be safely immediately loaded. No

difference was found between the immediate and the delayed standart protocols at 2 years.

Three implants reduce the cost of treatment and could interrest more patients. But extended

follow-up and inclusions observations will be necessary befoe this protocol will being the

standart procedure for edentulous people.

STEPHAN G.* : DDS, MCU-PH

Correspondence : Dr Grégory STEPHAN ; 33 bis Bd de la république -13100 Aix-en-

Provence - France

VIDOT F.** : DDS

NOHARET R.** : DDS

MARIANI P.**** : DDS, Professor

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73,61+/- 2,98

72,04+/- 4,32

72,92+/- 4,05

71,92+/- 4,03

73,44+/- 4,66

ControlGroup

70,22+/- 3,9

74,13+/- 3,22

71,47+/- 3,38

72,35+/- 3,87

73,29+/- 3,11

74,43+/- 2,53

TestGroup

24months

18months

12months

6months

3months

0months

ISQ mean values at 0,3,6,12,18 and 24 months after the beginning of the prosthetic load.(Mean +/- standard deviation of the mean). Student’s test did’nt show any differnece (p> 0,05)

Table 1

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0

10

20

30

40

50

60

70

80

90

100

General comfort Better chewing Better speaking Would do itagain

Self confiance Would advise it

ControlTest

Patient’s satisfaction (%) before and after implant placement : No difference was found between the delayed and immediate loading procedures (Chi-2 test)

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0,46+/- 0,46

ControlGroup

0+/- 0,0

0,05+/- 0,32

TestGroup

24months

12months

Peri-implant bone loss at 12 and 24 months after the beginning of the prosthetic load (Mean +/- standard deviation of the mean). A difference is present at 12 months(Student’s test, p> 0,05)

Table 2

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0,47+/- 0,66

0,41+/- 0,61

0,81+/- 0,8

0,78+/- 0,66

ControlGroup

1,33+/- 1,52

1,06+/- 1,14

0,91+/- 1,05

0,83+/- 1,05

0,96+/- 1,07

TestGroup

24months

18months

12months

6months

3months

Plaque index : mean values at 3,6,12,18 and 24 months after the beginningof the prosthetic load (Mean +/- standard deviation of the mean). Nostatistically difference was found (Student’s test, p> 0,05)

Table 3

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0,09+/- 0,16

0,12+/- 0,24

0,37+/- 0,45

ControlGroup

0+/- 0,0

0,13+/- 0,18

0,08+/- 0,15

0,13+/- 0,39

TestGroup

24months

18months

12months

3months

Bleeding index : mean values at 3,12,18 and 24 months after the beginning of the prosthetic load (Mean +/- standard deviation of the mean). No significant difference was found (Student’s test, p> 0,05)

Table 4

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1,83+/- 0,87

2,14+/- 0,56

2,05+/- 0,5

2,16+/- 0,66

ControlGroup

1,77+/- 0,53

1,76+/- 0,38

1,47+/- 0,32

1,57+/- 0,37

1,81+/- 0,76

TestGroup

24months

18months

12months

6months

3months

Pocket probing depth scores at 3,6,12,18 and 24 months after the beginning of the prosthetic load (Mean +/- standard deviation of the mean). Student’s test show a difference at 12 months (p> 0,05).

Table 5

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59. Romeo E, Chiapasco M, Lazza A, Casenti P, Ghisolfi M, Iorio M, Vogel G. Implant-retained mandibular overdentures with ITI implants. A comparison of 2-year results between delayed and immediate loading. Clinical Oral Implants Research 2002 ; 13 : 495-501

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74. Wismeijer D, Van Waas MA, Vermeeren JI, Mulder J, Kalk W. Patient satisfaction with implant-supported overdentures. A comparison of three

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treatment strategies with ITI-dental implants. International Journal of Oral and Maxillofacial Surgery1997 ; 26 : 153-62

75. Wismeijer D, Van Waas MA, Mulder J, Vermeeren JI, Kalk W. Clinical and radiological results of patients treated with three treatment modalities for overdentures on implants of the ITI Dental Implant System. A randomized controlled clinical trial. Clinical Oral Implants Research 1999 ; 10 : 297-306

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The aim of this clinical study was to compare the results between delayed and immediate

loading of three implant-retained mandibular overdentures. Peri-implant soft tissues, bone

resorption, implant stability (RFA) and patient’s satisfaction were evaluated. Preliminary

results of this prospective study seems show that 3 endosseous implants splinted with a gold

bar and supporting mandibular overdenture can be safely immediately loaded. No difference

was found between the immediate and the delayed standart protocols at 2 years. Three

implants reduce the cost of treatment and could interrest more patients.

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