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Completed

NCT Number: NCT07478978

Collagen Membrane and Allograft in Peri-Implantitis Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University Faculty of Dentistry

Samsun, Atakum, 55200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collagen Membrane + Allograft

Procedure

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

Allograft

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Acronym: CMAPI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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