Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06957652

Reconstructive Treatment of Peri-implantitis With Combined Defects

Led by Gazi University · Updated on 2025-05-04

60

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Reconstructive Treatment of Peri-implantitis With Combined Defects

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Peri-implantitis with probing pocket depth of 6 mm or more, bleeding and/or pus on probing, and bone loss of 3 mm or more on X-rays
  • Combined defect types with an intrabony part of 3 mm or more
  • At least 2 mm of keratinized gum tissue on the cheek side of the implant
  • Implants placed properly inside the bone
  • Implant-supported prosthesis allowing good oral hygiene and probing
Not Eligible

You will not qualify if you...

  • Full-mouth plaque score less than 25%
  • Full-mouth bleeding score less than 25%
  • Smoking 10 or more cigarettes per day
  • Active periodontal disease diagnosis
  • Acute or chronic medical conditions or medications like intravenous amino-bisphosphonates, immunosuppressants, or chemotherapy that may affect treatment
  • Antibiotic use within the last 3 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

Gazi University Faculty of Dentistry

Ankara, Turkey, Turkey (Türkiye), 06490

Actively Recruiting

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Research Team

S

Sila Cagri Isler, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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