About this trial
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
This trial does not accept healthy volunteersQualifiers
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%.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Access flap & surgical debridement
Procedure/SurgeryFollowing surgical exposure, roots are carefully debrided.
Application of bone substitute material (BioOss Collagen)
Procedure/SurgeryFollowing surgical debridement, the bone substitute material is applied to the furcation defect.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients/teeth displaying furcation closure.
Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.
Proportion of patients/teeth displaying furcation closure.
Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.
Proportion of patients/teeth displaying furcation closure.
Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.
Proportion of patients/teeth displaying furcation closure.
Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.
Secondary outcomes
Changes in probing pocket depth.
Reductions in PPD relative to baseline.
Changes in probing pocket depth.
Reductions in PPD relative to baseline.
Changes in probing pocket depth.
Reductions in PPD relative to baseline.
Changes in probing pocket depth.
Reductions in PPD relative to baseline.
Sponsors and contacts
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Göteborg University
Lead sponsor
Johann Wolfgang Goethe University Hospital
Collaborator
Charite University, Berlin, Germany
Collaborator
King's College London
Collaborator
Queen Mary University of London
Collaborator
Geistlich Pharma AG
Collaborator
Vastra Gotaland Region
Collaborator