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

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.

Conditions

• Periodontitis
• Furcation Defects

Interventions

PROCEDURE

Access flap & surgical debridement

Following surgical exposure, roots are carefully debrided.

PROCEDURE

Application of bone substitute material (BioOss Collagen)

Following surgical debridement, the bone substitute material is applied to the furcation defect.

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• King's College London

  collaborator OTHER

• Queen Mary University of London

  collaborator OTHER

• Geistlich Pharma AG

  collaborator INDUSTRY

• Vastra Gotaland Region

  collaborator OTHER_GOV

• Göteborg University

  lead OTHER

Principal Investigators

• Karolina Karlsson, PhD · Göteborg University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-27

Primary Completion

2028-03-01

Completion

2037-03-01

Countries

• Sweden

Study Locations