Collagen Membrane and Allograft in Peri-Implantitis Surgery (CMAPI)

March 17, 2026 updated by: Merve Topçu, Ondokuz Mayıs University

Comparison of the Use of Collagen Membrane Combined With Allograft Versus Allograft Alone in the Surgical Treatment of Peri-Implantitis

Peri-implantitis is an inflammatory condition characterized by inflammation of the peri-implant tissues and progressive loss of supporting bone around dental implants. Surgical treatment is often required in advanced cases to decontaminate implant surfaces and manage peri-implant bone defects. Regenerative approaches frequently include the use of bone graft materials and barrier membranes to promote bone regeneration and improve healing outcomes.

The aim of this randomized clinical trial is to evaluate whether the adjunctive use of a resorbable collagen membrane provides additional benefits when combined with an allograft in the surgical treatment of peri-implantitis. A total of 44 patients diagnosed with peri-implantitis associated with circumferential intrabony defects are randomly allocated into two groups: one treated with allograft combined with a collagen membrane and the other treated with allograft alone.

Clinical parameters including probing depth, bleeding on probing, and suppuration are recorded at baseline and during follow-up. Radiographic marginal bone levels are assessed using standardized periapical radiographs. In addition, peri-implant crevicular fluid samples are collected to measure platelet-derived growth factor (PDGF) and vascular endothelial growth factor (VEGF) levels as biochemical indicators of healing. The outcomes of the two treatment approaches are compared to determine whether the use of a collagen membrane provides additional clinical, radiographic, or biochemical benefits in peri-implantitis surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Peri-implantitis is a plaque-associated pathological condition characterized by inflammation of the peri-implant mucosa and progressive loss of supporting bone around dental implants. Due to the structural differences between periodontal and peri-implant tissues, peri-implantitis lesions often show rapid progression and may require surgical intervention in advanced cases. Surgical therapy aims to eliminate the inflammatory lesion, decontaminate the implant surface, and manage peri-implant bone defects.

Regenerative surgical approaches have been proposed to reconstruct peri-implant bone defects and improve treatment outcomes. Bone graft materials are commonly used to provide an osteoconductive scaffold and promote new bone formation. In addition, barrier membranes may be used to stabilize the grafted area and prevent the migration of epithelial and connective tissue cells into the defect site. Resorbable collagen membranes are widely used because of their biocompatibility, resorbability, and ability to support wound stabilization during the healing process.

However, the adjunctive benefit of using a collagen membrane together with a bone graft in the surgical treatment of peri-implantitis remains controversial. Furthermore, limited data are available regarding the biological response associated with these regenerative procedures.

The present randomized clinical trial aims to evaluate the adjunctive effect of a resorbable collagen membrane used in combination with an allograft in the surgical treatment of peri-implantitis. A total of 44 patients diagnosed with peri-implantitis associated with circumferential intrabony defects are randomly assigned to one of two treatment groups: (1) allograft combined with a resorbable collagen membrane (test group) and (2) allograft alone (control group).

Clinical parameters including probing depth, bleeding on probing, and suppuration are recorded at baseline and during follow-up examinations. Radiographic marginal bone levels are evaluated using standardized periapical radiographs. In addition, peri-implant crevicular fluid samples are collected at baseline, 1 month, and 3 months to determine platelet-derived growth factor (PDGF) and vascular endothelial growth factor (VEGF) levels using ELISA. These biochemical markers are analyzed to evaluate the biological healing response following surgical treatment.

The outcomes of the two treatment approaches are compared in terms of clinical, radiographic, and biochemical parameters in order to determine whether the use of a collagen membrane provides additional benefit in the reconstructive surgical treatment of peri-implantitis.

Study Type

Interventional

Enrollment (Actual)

44

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

  • Turkey (Türkiye)
    • Atakum
      • Samsun, Atakum, Turkey (Türkiye), 55200
        • Ondokuz Mayıs 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with peri-implantitis characterized by bleeding and/or suppuration on probing and increased probing depth around dental implants.
  • Presence of circumferential intrabony peri-implant defects requiring reconstructive surgical treatment.
  • Patients aged 18 years or older.
  • Presence of functioning dental implants in the oral cavity.
  • Patients who are able and willing to attend follow-up visits and provide informed consent.

Exclusion Criteria:

  • Patients with uncontrolled systemic diseases that could affect wound healing.
  • Use of antibiotics or anti-inflammatory drugs within the last 3 months.
  • Pregnancy or lactation.
  • Heavy smoking habits.
  • Poor oral hygiene or lack of compliance with periodontal maintenance therapy.
  • Previous surgical treatment for peri-implantitis at the study site.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allograft + Collagen Membrane
Participants receive reconstructive surgical treatment for peri-implantitis using a particulate allograft alone without the use of a collagen membrane following implant surface decontamination and defect debridement.
Procedure: Collagen Membrane + Allograft
Reconstructive surgical treatment of peri-implantitis in which peri-implant bone defects are filled with particulate allograft and covered with a resorbable collagen membrane following implant surface decontamination and defect debridement.
Other Names:
  • Bone Allograft
  • Particulate Allograft
Active Comparator: Allograft Alone
Participants receive reconstructive surgical treatment for peri-implantitis using particulate allograft alone following implant surface decontamination and defect debridement. No collagen membrane is applied in this group.
Procedure: Allograft
Reconstructive surgical treatment of peri-implantitis in which peri-implant bone defects are filled with particulate allograft alone following implant surface decontamination and defect debridement, without the use of a collagen membrane.
Other Names:
  • Bone Allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing Depth (PD)
Time Frame: Baseline to 6 months after surgery
Change in peri-implant probing depth measured with a periodontal probe to evaluate the clinical effectiveness of reconstructive surgical treatment of peri-implantitis using allograft with or without a resorbable collagen membrane.
Baseline to 6 months after surgery
Change in Bleeding on Probing (BoP)
Time Frame: Baseline to 6 months after surgery
Change in bleeding on probing around dental implants used to evaluate peri-implant tissue inflammation following reconstructive surgical treatment.
Baseline to 6 months after surgery
Change in Suppuration on Probing
Time Frame: Baseline to 6 months after surgery
Change in the presence of suppuration around implants as an indicator of infection resolution after surgical treatment of peri-implantitis.
Baseline to 6 months after surgery
Change in Radiographic Marginal Bone Level
Time Frame: Baseline to 6 months after surgery
Radiographic evaluation of marginal bone levels around implants using standardized periapical radiographs to assess bone regeneration after reconstructive surgery.
Baseline to 6 months after surgery
Change in PDGF Levels in Peri-implant Crevicular Fluid
Time Frame: Baseline to 6 months after surgery
Evaluation of platelet-derived growth factor (PDGF) levels in peri-implant crevicular fluid to assess the biological healing response following treatment.
Baseline to 6 months after surgery
Change in VEGF Levels in Peri-implant Crevicular Fluid
Time Frame: Baseline to 6 months after surgery
Evaluation of vascular endothelial growth factor (VEGF) levels in peri-implant crevicular fluid as a biomarker of angiogenesis and tissue healing after peri-implantitis surgery.
Baseline to 6 months after surgery

Collaborators and Investigators

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

Sponsor

Ondokuz Mayıs University

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)

December 12, 2024

Primary Completion (Actual)

June 15, 2025

Study Completion (Actual)

October 15, 2025

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMU-KAEK-2024/21
  • BAP04-B-2024-5660 (Other Grant/Funding Number: Ondokuz Mayıs University Scientific Research Projects Commission (BAP))

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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