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

Ondokuz Mayıs University1 个研究点分布在 1 个国家目标入组 44 人开始时间: 2024年12月12日最近更新: 2026年3月19日

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 44
试验地点: 1
主要终点: Change in Probing Depth (PD)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.

研究组 & 干预措施

Allograft + Collagen Membrane

Experimental

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.

干预措施: Collagen Membrane + Allograft (Procedure)

Allograft Alone

Active Comparator

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.

干预措施: Allograft (Procedure)