NCT06270303

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

Recruiting now NA Last updated 21 August 2025

What this trial tests

NA trial testing Access flap & surgical debridement in Periodontitis in 200 participants. Currently enrolling.

Timeline

27 March 2025

Primary endpoint
1 March 2028

1 March 2037

Quick facts

Lead sponsor	Göteborg University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	200
Start date	27 March 2025
Primary completion	1 March 2028
Estimated completion	1 March 2037
Sites	1 location across Sweden

Drugs / interventions tested

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

Conditions studied

• Periodontitis — all drugs for Periodontitis →
• Furcation Defects — all drugs for Furcation Defects →

Sponsor

Göteborg University

Who can join

18 and older, any sex, with Periodontitis or Furcation Defects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.