Reconstructive Surgical Therapy of Peri-implantitis

February 24, 2021 updated by: Sıla Çağrı İşler, Gazi University

Reconstructive Surgical Therapy of Peri-implantitis: 3-year Results of a Randomized Clinical Trial

Various treatment protocols of peri-implantitis involving surgical therapies with open flap debridement procedures, resective or reconstructive modalities have been documented to achieve variable success. Surgical non-reconstructive approaches have been suggested to have limited effectiveness in terms of the resolution of inflammation in the long term. Therefore, much more interest has been intensified regarding the efficacy of biomaterials used in reconstructive approaches. The aim of this study was to investigate the 3-year clinical/radiographic outcomes of reconstructive surgical therapy of peri-implantitis using a bone substitute combined with two different bioresorbable barrier membranes, either collagen membrane (CM) or concentrated growth factor (CGF). A total of 52 patients who had at least one implant diagnosed with peri-implantitis and needed to be scheduled for reconstructive therapy of a peri-implant infrabony defect were included. Peri-implantitis case was defined as increased probing depth (PD) compared to previous examinations with bleeding on probing (BOP) and/or suppuration and radiographic evidence of peri-implant bone loss beyond crestal bone level changes resulting from initial bone remodeling. The patients were randomly assigned to receive a bone substitute filling in combination with either CM or CGF. Intrabony components were filled with a bone substitute (BioOss spongiosa granules; Geistlich, Wolhusen, Switzerland) and covered with a CM (Bio-Guide, Geistlich Biomaterials) or CGF membrane. The plaque index (PI), gingival index (GI), BOP, PD, clinical attachment level (CAL), mucosal recession (MR) and radiographic vertical defect depth (VDD) values were evaluated at 1 and 3 years postoperatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Peri-implantitis is a plaque-associated pathological disease affecting the soft and/or hard tissues surrounding a dental implant and clinically characterized by bleeding on probing (BOP) and/or suppuration (Supp), increased probing depths (PDs) and/or mucosal marginal recessions (MRs) in addition to radiographic marginal bone loss (MBL) compared to previous examinations. Considering the increasing numbers of patients undergoing restorative treatment through dental implants and the corresponding increase in the prevalence of peri-implantitis, it is imperative to perform effective treatment methods for the management of these conditions. On the basis of evidence, the most reliable and predictable treatment of peri-implantitis has not yet been described, moreover, if the disease is left untreated, it progresses in a non-linear accelerating manner. Hence, peri-implantitis has been considered to be a major, unpredictable and growing problem for clinicians.

Various treatment protocols of this challenging problem involving non-surgical approaches and surgical therapies with open flap debridement procedures, resective surgeries, or reconstructive modalities, which include the use of bone substitutes with or without a membrane, decontamination methods of implant surfaces, antimicrobial prescriptions whether to use submerged or non-submerged techniques, have been proposed. Although non-surgical interventions have been reported to be effective in reducing BOP and PDs in peri-implantitis sites, these therapies have appeared to be unpredictable for the management of peri-implantitis, especially in most severe cases. As another treatment option, surgical non-reconstructive approaches, i.e. open flap debridement and surface decontamination alone, have been suggested to have limited effectiveness in terms of the resolution of inflammation for the long-term outcomes. Therefore, much more interest has been intensified regarding the efficacy of biomaterials used in reconstructive approaches. Several surgical augmentative therapy studies, including the use of bone substitutes with or without barrier membranes have demonstrated significant clinical and radiographic improvements for at least 3 years, especially in well-contained (three- or four-wall) intrabony defects. A systematic review evaluating long-term outcomes of reconstructive therapy for the management of peri-implantitis showed a mean PD reduction of 3 mm and a radiographic gain of 2.4 mm in bone level. However, as indicated by the last EFP Workshop, no evidence to support the superiority of a specific material, product or membrane in terms of long-term clinical outcomes of a reconstructive approach has been found. It has been strictly recommended that identification of peri-implantitis therapy success and disease resolution in the long-term management are required to allow adequate assessment of stable treatment outcomes.

Because of many studies indicating that growth factors have provided to transiently stimulate cells locally, accelerate angiogenesis, promote proliferation, differentiation, and regeneration, the additional use of them in the management of peri-implantitis has been proposed to improve the clinical outcomes and enhance soft and hard tissue regeneration. A recent systematic review and meta-analysis has been suggested that growth factors might be associated with better outcomes with regard to PD and BOP, whereas, they did not reveal statistically significant evidence for yielding additional benefits in the treatment of peri-implantitis. A randomized clinical trial (RCT) on the reconstructive surgical treatment of peri-implantitis evaluating concentrated growth factor (CGF) used as a bioresorbable barrier membrane in combination with a bone substitute, was performed recently by our study group and demonstrated significant improvements in both clinical and radiographic assessments at 1-year follow-up. Nevertheless, there is scarce information in the literature regarding the predictability and long-term stability of autologous growth factors in peri-implantitis management.

It is, therefore, the aim of this study to investigate the 3-year clinical/radiographic outcomes of reconstructive surgical therapy of peri-implantitis using a bone substitute combined with two different bioresorbable barrier membranes, either collagen membrane (CM) or CGF, and moreover, to identify prognostic indicators influencing the long-term reconstructive surgical treatment outcome using a multilevel statistical model.

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06490
        • Gazi University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Presence of bleeding on probing (BOP) and/or suppuration (SUP) on gentle probing, and a radiographic marginal bone loss (MBL) ≥ 2 mm based on baseline radiographs taken at the time of prosthesis delivery with increased probing depth (PD) compared to previous examinations.

Description

Inclusion Criteria:

  • age > 18 years,
  • having at least one implant demonstrating two- or three-wall infrabony defect ≥3 mm, which presented a probing depth of ≥5 mm with BOP and/or suppuration,
  • no implant mobility and no evidence of occlusal overload.

Exclusion Criteria:

  • serious systemic diseases, medications or conditions that would contraindicate for periodontal surgery and compromise wound healing,
  • a history of taking systemic antibiotic during the past 3 months, and
  • placement, and prosthetic loading of implants within the past year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Concentrated growth factor (CGF) group
Reconstructive surgical therapy of peri-implantitis using a bone substitute combined with CGF
Device: bioresorbable membrane
reconstructive surgical treatment of peri-implant bone defects
Collagen membrane (CM) group
Reconstructive surgical therapy of peri-implantitis using a bone substitute combined with CM
Device: bioresorbable membrane
reconstructive surgical treatment of peri-implant bone defects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean vertical radiographic defect depth (VDD)
Time Frame: Postoperative 3 years
Radiographic vertical defect depth (VDD) was measured between the first bone-to-implant contact and the reference point at the coronal part of the implant body at both mesial and distal aspects of the implants.
Postoperative 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index
Time Frame: Baseline, postoperative 1 and 3 years
Silness & Löe plaque index (PI) marked with a score from 0 to 3 (0: absence of microbial plaque; 1: thin film of microbial plaque; 2: moderate accumulation with plaque in the sulcus; 3: large amount of plaque in sulcus or pocket along the free gingival margin)
Baseline, postoperative 1 and 3 years
Gingival index
Time Frame: Baseline, postoperative 1 and 3 years
Löe & Silness index (GI) marked with a score from 0 to 3. (0: normal gingiva; 1: mild inflammation, 2: moderate inflammation, 3: severe inflammation)
Baseline, postoperative 1 and 3 years
Bleeding on probing (percent [%]) (BOP)
Time Frame: Baseline, postoperative 1 and 3 years
BOP was assessed according to presence or absence of bleeding 30 s after gentle probing
Baseline, postoperative 1 and 3 years
Probing depth (mm) (PD)
Time Frame: Baseline, postoperative 1 and 3 years
PD was measured as the distance from the mucosal margin to the bottom of the probeable pocket
Baseline, postoperative 1 and 3 years
Clinical attachment level (mm) (CAL)
Time Frame: Baseline, postoperative 1 and 3 years
Clinical attachment level (CAL) defined as PD+ mucosal recession.
Baseline, postoperative 1 and 3 years
Mucosal recession (mm) (MR)
Time Frame: Baseline, postoperative 1 and 3 years
Mucosal recession (MR) was measured as the distance from the mucosal margin and the implant abutment interface
Baseline, postoperative 1 and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

February 12, 2021

Study Completion (Actual)

February 12, 2021

Study Registration Dates

First Submitted

February 21, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUDHKAEK.2021.01/4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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