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

Ondokuz Mayıs University

Status: Completed

Conditions: Biochemical Markers; Peri-implantitis; Guided Bone Regeneration

Treatments: Procedure: Collagen Membrane + Allograft; Procedure: Allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT07478978

BAP04-B-2024-5660 (Other Grant/Funding Number)

OMU-KAEK-2024/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Allograft + Collagen Membrane

Experimental group

Description:

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.

Treatment:

Procedure: Collagen Membrane + Allograft

Allograft Alone

Active Comparator group

Description:

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.

Treatment:

Procedure: Allograft