Reconstructive treatment for gum disease around dental implants
Reconstructive Treatment of Combined Peri-implantitis-related Defects With or Without Collagen Membrane: A Randomized Clinical Study
This study is testing if adding a special membrane to a bone graft can help people with gum disease around dental implants heal better than just using the bone graft alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Gazi University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ankara, Turkey) |
| Trial ID | NCT06957652 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the effectiveness of using a resorbable collagen membrane in conjunction with a xenogeneic bone graft for treating peri-implantitis with complex defect configurations. A total of 60 patients will be randomly assigned to receive either the combination treatment or the bone graft alone. The study will assess both clinical outcomes and patient-reported outcomes to determine if the addition of the membrane provides significant benefits over the standard treatment. The focus is on understanding how different defect types may respond to these treatments.
Who should consider this trial
Good fit: Ideal candidates are individuals with peri-implantitis characterized by specific defect configurations and adequate oral hygiene.
Not a fit: Patients with low plaque and bleeding scores, active periodontal disease, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients suffering from peri-implantitis.
How similar studies have performed: While some studies have shown mixed results regarding the use of barrier membranes in similar contexts, this specific approach targeting combined defects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ankara, Turkey
- Gazi University Faculty of Dentistry — Ankara, Turkey, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Sila Cagri Isler, PhD
- Email: silaisler@gazi.edu.tr
- Phone: +905069966074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.