Actively Recruiting
Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects
Led by Göteborg University · Updated on 2025-08-21
200
Participants Needed
1
Research Sites
622 weeks
Total Duration
On this page
Sponsors
G
Göteborg University
Lead Sponsor
J
Johann Wolfgang Goethe University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with at least one surgically accessible molar (tooth position 6 or 7) diagnosed with a single furcation defect degree II at any aspect
- After initial periodontal therapy, teeth must have a furcation defect degree II combined with bleeding on probing
- Probing pocket depth of 6 mm or more at the site of the furcation defect
- Soft tissue covers the furcation entrance at the affected site
- Full mouth plaque score of 25% or less
You will not qualify if you...
- Multiple deep furcation defects (degree II or III) on the same tooth
- Vertical attachment loss greater than 50% on aspects not facing the furcation defect
- Defects with apico-marginal communication
- Use of systemic antibiotics within the last 6 months
- Medical conditions or medications that impede surgery, such as uncontrolled diabetes or immunosuppressive therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Periodontology, Institute of Odontology
Gothenburg, Sweden, 40530
Actively Recruiting
Research Team
J
Jan Derks, PhD
CONTACT
K
Kostas Bougas, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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