Ondokuz Mayıs University Faculty of Dentistry
Samsun, Atakum, 55200, Turkey (Türkiye)
NCT Number: NCT07478978
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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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Samsun, Atakum, 55200, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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.
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.
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.
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.
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.
Ondokuz Mayıs University
Other
Comparison of the Use of Collagen Membrane Combined With Allograft Versus Allograft Alone in the Surgical Treatment of Peri-Implantitis
Acronym: CMAPI
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