Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects
Trial Parameters
Brief Summary
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 level, need for surgical retreatment, tooth loss, patient-reported outcomes and adverse events. A composite outcome based on furcation closure (degree ≤I) in combination with shallow probing depth (≤5 mm) and absence of bleeding on probing will also be evaluated.
Eligibility 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)