Peri-implantitis - Reconstructive Surgical Therapy

October 10, 2024 updated by: Göteborg University

Reconstructive Surgical Therapy of Peri-implantitis-related Osseous Defects. A Multicenter Randomized Controlled Clinical Trial

The project will evaluate the potential benefit of the use of bone replacement graft as an adjunct to surgical therapy of peri-implantitis. The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in 7 clinical centers. 140 systemically healthy patients diagnosed with peri-implantitis will randomly assigned to be treated with or without bone replacement graft. Outcome measures include assessments of inflammation, probing depth, recession, radiological parameters and PROMs.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective The overall objective of the project is to evaluate the clinical efficacy of the use of a bone substitute material in reconstructive surgical therapy of peri-implantitis-associated osseous defects.

Hypothesis: The use of a bone substitute material in reconstructive therapy of peri-implantitis increases the likelihood to achieve treatment success.

Relevance for clinical practice The project will provide significant contribution to the understanding of outcomes using reconstructive procedures in treatment of peri-implantitis.

Study population, design and treatment procedures The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in 7 clinical centers. 140 systemically healthy patients with implants ≥1 year in function and diagnosed with advanced peri-implantitis at ≥1 implants will be enrolled.

Inclusion criteria Age ≥ 18 years

≥1 implant (≥1 year of function) presenting with PPD ≥7 mm and BoP/Pus. Confirmed bone loss ≥3 mm at same implant(s)

Exclusion criteria Treated for peri-implantitis during previous 6 months Intake of systemic or local antibiotics during previous 6 months Systemic conditions affecting peri-implant tissues Systemic conditions impeding surgical intervention

Surgical procedures Surgical procedures will be performed one month after a baseline examination and initiation of plaque control. Three days before surgery a 10-day systemic antibiotic regimen will be initiated. Full thickness flaps will be elevated and inflamed tissues will be removed. The implant surfaces will be cleaned with mini-gauze soaked in saline. The osseous defect should be ≤4 mm wide and >3 mm deep. The defect should in addition to the mesial and distal bone walls preferably exhibit at least a lingual or a buccal bone wall. The randomly assigned treatment strategy, stratified for smoking, will be revealed after debridement. Test procedure: The defect will be filled with Bio-Oss Collagen® and the flaps will be sutured to their previous position. Control procedure: Flaps will be sutured to their previous position. Sutures will be removed 2 weeks after treatment, followed by a 6-week control. Clinical examinations will be performed at 6, 12, 24, 36, 48 and 60 months after therapy. Maintenance therapy will be provided based on individual needs.

Clinical assessments One calibrated examiner in each clinical center will perform the assessments. The following variables will be assessed at four sites around the implant: Plaque, probing pocket depth (PPD), bleeding on probing (BoP), probing attachment level (PAL) and recession (REC).

Treatment success Treatment success will be defined as the absence of BoP/Pus, PPD ≤5 mm and ≤1 mm recession. Peri-implant sites showing BoP and PPD ≥6 mm at re-examination will be scheduled for further treatment. Patient-related outcome variables will be assessed at baseline and follow-up and include esthetic and functional appreciation, pain or discomfort.

Radiographic assessments Intra-oral radiographs will be obtained prior to surgery (baseline) and at 1-, 3- and 5-year re-examinations. Analysis of radiographs will be performed by specialists in oral-maxillofacial radiology. The examiners will be blinded to treatment procedures. The assessment will include defect fill and crestal bone support.

Power calculation A total of 122 patients (61 per group) will provide a power of 80% with alpha set at 0.05 to detect a difference of 1 mm in mean PPD change between groups, given a SD of 1.97 (Carcuac et al., 2016). 140 individuals will be included to compensate for drop-out.

Data analysis Mean changes for the various variables and the proportion of sites fulfilling the criteria for treatment success will be calculated. A multilevel model with the clinical center as the highest level and the implant as the lowest will be built to test the influence of measured factors on the outcomes and to compensate for potential clustering of data. Data analysis including multilevel modeling will be conducted in collaboration with a biostatistician.

Schedule of investigational events

  1. Screening and identification of subjects.
  2. Baseline clinical examination of implants selected for the study. Case presentation and reinforcement of self-performed plaque control. Assessment of PROM. Professional mechanical infection control.
  3. Radiographic examination prior to surgical therapy (within 4 weeks).
  4. Surgical therapy including test and control treatment procedures at study sites.
  5. 2 weeks - suture removal. Assessment of PROM.
  6. 6 weeks - professional supra-mucosal cleaning and reinforcement of oral hygiene.
  7. 6 months - clinical examination.
  8. 12 months - clinical and radiological examination. Assessment of PROM.
  9. 24 months - clinical examination.
  10. 36 months - clinical and radiological examination. Assessment of PROM.
  11. 48 months - clinical examination.
  12. 60 months - clinical and radiological examination. Assessment of PROM.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

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

  • Sweden
      • Göteborg, Sweden, 40530
        • Department of Periodontology, Institute of Odontology

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • ≥1 implant (≥1 year of function) presenting with PPD ≥7 mm and BoP/Pus.
  • Confirmed bone loss ≥3 mm at same implant(s)

Exclusion Criteria:

  • Treated for peri-implantitis during previous 6 months
  • Intake of systemic or local antibiotics during previous 6 months
  • Systemic conditions affecting peri-implant tissues
  • Systemic conditions impeding surgical intervention

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control - Open flap debridement
The surgical procedure includes flap elevation, debridement of the peri-implant defect and decontamination of the implant surfaces using saline for irrigation. Flaps are replaced in their original position and carefully sutured. Patients are provided with post-surgical information and thereafter called in for regular follow-up visits.
Procedure: Open flap debridement
Open flap debridement using saline as irrigation
Experimental: Test - Bone replacement graft
The surgical procedure is identical to the control procedure with the exception of the application of the bone replacement graft. Following decontamination, Bio-Oss Collagen® is placed into the peri-implant bony defect. Flaps are carefully sutured and patients are provided with the same information and follow-up as patients in the control group.
Procedure: Open flap debridement
Open flap debridement using saline as irrigation
Device: Bone replacement graft
Open flap debridement using saline as irrigation including a grafting procedure withBio-Oss Collagen®.
Other Names:
  • Bio-Oss Collagen®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success (year 1)
Time Frame: Assessed at year 1
Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm recession of mucosal margin
Assessed at year 1
Treatment success (year 3)
Time Frame: Assessed at year 3
Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm recession of mucosal margin
Assessed at year 3
Treatment success (year 5)
Time Frame: Assessed at year 5
Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm
Assessed at year 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic outcomes
Time Frame: Assessed at 1, 3 and 5 years
Defect fill and crestal bone support
Assessed at 1, 3 and 5 years
Patient-reported outcomes
Time Frame: Prior to intervention and at 1, 3 and 5 years
Patient-reported outcomes assessed by questionnaire and in relation to baseline
Prior to intervention and at 1, 3 and 5 years

Collaborators and Investigators

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

Sponsor

Göteborg University

Collaborators

Osteology Foundation

Investigators

  • Principal Investigator: Tord Berglundh, Professor, Göteborg 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)

April 1, 2017

Primary Completion (Actual)

March 14, 2022

Study Completion (Estimated)

March 14, 2026

Study Registration Dates

First Submitted

February 24, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1192-16

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

product manufactured in and exported from the U.S.

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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