Using a bone substitute material to treat furcation defects in molars
The Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects - a Multi-center Randomized Controlled Trial
NA · Göteborg University · NCT06270303
This study is testing if adding a special bone material during surgery can help people with gum issues in their molars heal better than just the standard treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Göteborg University (other) |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT06270303 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a bone substitute material in the surgical treatment of degree II furcation defects in molars. It involves 200 patients who will be randomly assigned to receive either standard open-flap debridement or the same procedure with the addition of a bone substitute material. The primary outcome is the closure of the furcation defect, while secondary outcomes include various clinical measurements and patient-reported outcomes. The study will follow participants for up to 10 years to assess long-term effects.
Who should consider this trial
Good fit: Ideal candidates are patients with at least one molar exhibiting a degree II furcation defect and meeting specific periodontal health criteria.
Not a fit: Patients with multiple deep furcation defects or significant vertical attachment loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes for patients with furcation defects, potentially leading to better tooth retention and periodontal health.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients should present with at least one surgically accessible molar (in tooth position 6 or 7) diagnosed with a single furcation defect degree II (at any aspect). Following initial periodontal therapy, teeth to be included should present with one site with furcation defect degree II in combination with: * Bleeding on probing * Probing pocket depth of ≥6 mm * Soft tissue coverage of the furcation entrance Patients should present with a full mouth plaque score ≤25%. Exclusion Criteria: * Multiple deep furcation defects (degree II - III) at the same tooth * Vertical attachment loss \>50% at aspects not facing the furcation defect * Defects presenting with apico-marginal communication * Intake of systemic antibiotics within 6 months * Systemic conditions/medication impeding surgical intervention (e.g. uncontrolled diabetes, immunosuppressive medication)
Where this trial is running
Gothenburg
- Department of Periodontology, Institute of Odontology — Gothenburg, Sweden (RECRUITING)
Study contacts
- Study coordinator: Jan Derks, PhD
- Email: jan.derks@odontologi.gu.se
- Phone: +46766183124
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.
Conditions: Periodontitis, Furcation Defects, Surgical therapy, Reconstructive, Randomized controlled trial