The Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects - a Multi-center Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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%.

Locations
Other Locations
Sweden
Department of Periodontology, Institute of Odontology
RECRUITING
Gothenburg
Contact Information
Primary
Jan Derks, PhD
jan.derks@odontologi.gu.se
+46766183124‬
Backup
Kostas Bougas, PhD
kostas.bougas@gu.se
+46766181208
Time Frame
Start Date: 2025-03-27
Estimated Completion Date: 2037-03-01
Participants
Target number of participants: 200
Treatments
Experimental: Access flap + bone substitute
Furcation defect will be treated by access flap debridement followed by application of a bone substitute material.
Active_comparator: Access flap
Furcation defect will be treated by access flap debridement alone.
Related Therapeutic Areas
Sponsors
Collaborators: Queen Mary University of London, Charite University, Berlin, Germany, Geistlich Pharma AG, Vastra Gotaland Region, King's College London, Johann Wolfgang Goethe University Hospital
Leads: Göteborg University

This content was sourced from clinicaltrials.gov