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

Condition(s) studied

Investigational drug(s) / intervention(s)

Access flap & surgical debridement: Following surgical exposure, roots are carefully debrided.

Application of bone substitute material (BioOss Collagen): Following surgical debridement, the bone substitute material is applied to the furcation defect.

Study 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

Primary outcome measure(s)

• Proportion of patients/teeth displaying furcation closure. — 6 months.
  Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.
• Proportion of patients/teeth displaying furcation closure. — 12 months.
  Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.
• Proportion of patients/teeth displaying furcation closure. — 3 years.
  Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.
• Proportion of patients/teeth displaying furcation closure. — 5 years.
  Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.
• Proportion of patients/teeth displaying furcation closure. — 7 years.
  Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.
• Proportion of patients/teeth displaying furcation closure. — 10 years.
  Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.

Trial sites (1)

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