Reconstructive Treatment of Peri-implantitis With Combined Defects

Recruiting now · Not applicable

Conditions studied: Peri-implantitis

In brief

The aim of this randomized clinical study is to assess the additional clinical benefit of incorporating a resorbable collagen membrane (CM) alongside a xenogeneic bone graft-specifically, deproteinized bovine bone mineral with 10% collagen (DBBM-C)-in the reconstructive surgical treatment of peri-implantitis involving combined (i.e., contained and non-contained) defect configurations. Accordingly, the study addresses the following research questions: * Does the adjunctive use of a CM in combination with DBBM-C improve treatment success compared to DBBM-C alone in the management of combined peri-implantitis-related defects? * Does the combined use of a CM and DBBM-C lead to superior patient-reported outcomes (PROs) compared to the use of DBBM-C alone in the reconstructive treatment of such defects? A total of 60 patients who have been referred to the Gazi University Department of Periodontology will be randomly assigned to receive test (DBMM-C +CM) or control group (DBMM-C) treatments. Clinical parameters will be assessed at baseline (i.e., prior to surgery), and at the 6-, and 12-month post-operatively. Radiographic examinations will be carried out at baseline and 12 months post-operatively. Patient oral health related to the treatment procedures will be evaluated using a written questionnaire \[Oral Health Impact Profile (OHIP-14)\] prior to treatment and after 2 weeks, 1, and 12 months following surgical therapy. Regarding post-treatment pain and overall patient satisfaction with treatment modalities, responses will be scored on a visual analog scale (VAS, 100 mm).

Key facts

Study ID: NCT06957652
Run by: Gazi University
People needed: 60
Starts: 2025-04-01
Expected to finish: 2026-12-01
Last updated by the study team: 2025-05-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Peri-implantitis defined as the presence of a peri-implant probing pocket depth (PPD) ≥6 mm with bleeding and/or suppuration on probing (BoP/SoP) and radiographic marginal bone loss (MBL) ≥3 mm.
Presence of combined defect configuration Class [Ib, Ic, Ie with horizontal components (i.e. Class II) (Schwarz et al., 2010)] with an intrabony compartment of ≥3 mm.
Presence of a minimum width of 2 mm of keratinized peri-implant mucosa on the buccal aspect of the implant.
Implants placed in proper position (inside the bony housing)
Having an implant-supported prosthesis that allows for adequate oral hygiene procedures and peri-implant probing.

You may not qualify if…

Full-mouth plaque score (FMPS) < 25%
Full-mouth bleeding score (FMBS) < 25%
Cigarette smoking < 10 cig./day,
Diagnosed with active periodontal disease,
Having acute or chronic medical conditions or undergoing medications, such as intravenous amino-bisphosphonates, immunosuppressive drugs, and chemotherapy, that could interfere with the treatment outcome,
Receiving antibiotic treatment in the previous 3 months.

Where it is running

Gazi University Faculty of Dentistry — Ankara, Turkey, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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