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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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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