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Reconstructive Treatment of Peri-implantitis With Combined Defects

NCT06957652 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-04

No results posted yet for this study

Summary

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).

Conditions

  • Peri-implantitis

Interventions

DEVICE

DBMM-C plus Resorbable collagen membrane

A trapezoidal flap design will be employed, including a sulcular incision and vertical releasing incisions extending approximately 2-3 mm beyond the mucogingival junction. Flap advancement will be facilitated through a periosteal-releasing incision at the flap base. Granulation tissue will be removed using a titanium curette, and implant surface decontamination will be performed with a titanium brush. The graft material will be placed in both supra- and intrabony defect components, followed by coverage with a resorbable collagen membrane. The flaps will then be coronally advanced and stabilized over the biomaterials.

DEVICE

DBMM-C

A trapezoidal flap design will be employed, including a sulcular incision and vertical releasing incisions extending approximately 2-3 mm beyond the mucogingival junction. Flap advancement will be facilitated through a periosteal-releasing incision at the flap base. Granulation tissue will be removed using a titanium curette, and implant surface decontamination will be performed with a titanium brush. The graft material will be placed in both supra- and intrabony defect components, and then the flaps will be coronally advanced and stabilized over the graft material.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-10-01
Completion
2026-12-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06957652 on ClinicalTrials.gov