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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGöteborg University

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

Qualifiers

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

Treatments tested in this trial

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

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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