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Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects

RecruitingNAAges 18 Years - anyAllGöteborg University
NCT06270303 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 trial is to evaluate the potential benefit of the use of a bone substitute material in the treatment of furcation degree II-involved molars. The main question it aims to answer is: What is the benefit of the adjunctive use of a bone substitute material in the surgical treatment of furcation degree II-involved molars when compared to open-flap debridement alone? 200 patients with ≥1 molar presenting with a furcation defect degree II will be included and randomized to either control (open-flap debridement) or test treatment (open-flap debridement + bone substitute material). The primary outcome of the study is furcation closure defined as absence of clinically detectable furcation involvement degree \>I. Secondary outcomes include changes in bleeding on probing, probing depth, vertical and horizontal attachment levels, soft tissue level, marginal bone l

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📋 Eligibility rules (as published)
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)
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What it tests

  • Access flap & surgical debridement
  • Application of bone substitute material (BioOss Collagen)
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Where

1 site
Department of Periodontology, Institute of Odontology
Gothenburg, Sweden
🤝 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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