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Reconstructive Treatment of Peri-implantitis With Combined Defects

RecruitingNAAges 18 Years - 75 YearsAllGazi University
NCT06957652 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 Period

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • DBMM-C plus Resorbable collagen membrane
  • DBMM-C
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Where

1 site
Gazi University Faculty of Dentistry
Ankara, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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