Actively Recruiting
The Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects - a Multi-center Randomized Controlled Trial
Led by Göteborg University · Updated on 2025-08-21
200
Participants Needed
1
Research Sites
469 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
This research aims to evaluate the benefit of using a bone substitute material in the surgical treatment of molars with furcation degree II defects compared to surgery alone. The trial includes 200 patients with at least one molar exhibiting this condition. The study will measure outcomes such as furcation closure, changes in probing depth, bleeding on probing, attachment levels, soft tissue levels, bone levels, need for retreatment, tooth loss, patient satisfaction, and adverse events over a long-term follow-up. Participants will first receive non-surgical periodontal therapy including plaque control and instrumentation, followed by surgery under local anesthesia. The procedure involves elevating flaps, removing inflamed tissue, and cleaning root surfaces. Patients are randomized to receive either surgery with a bone substitute material placed in the furcation defect or surgery alone. After surgery, patients avoid mechanical cleaning in the treated area for 4 weeks and use chlorhexidine rinses. Sutures are removed after 2 weeks, and follow-up visits occur at 4 weeks and multiple times up to 10 years. During the study, clinical assessments include measuring furcation degree, attachment levels, bleeding, plaque, probing depth, and soft tissue levels. Radiographic images are taken at baseline and several later points. Inflammatory markers in fluid samples from the gums are analyzed in some centers. Patient-reported outcomes on satisfaction and discomfort are collected through questionnaires. Data analysis accounts for factors like smoking and tooth location, with examiners blinded to treatment groups. The primary outcome is the proportion of teeth showing furcation closure at various time points up to 10 years.
CONDITIONS
Brief 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 must have at least one surgically accessible molar (tooth position 6 or 7) with a single furcation defect degree II
- Included teeth should have bleeding on probing, probing pocket depth of 6 mm or more, and soft tissue covering the furcation entrance
- Full mouth plaque score must be 25% or less
- Patients must have completed initial periodontal therapy
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 past 6 months
- Systemic conditions or medications that prevent surgery, such as uncontrolled diabetes or immunosuppressive drugs
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 to 16 weeks
Participants receive tailored non-surgical periodontal therapy including instructions for plaque control and supra- and subgingival instrumentation, followed by an examination 8 to 16 weeks after therapy completion.
1 to 2 visits (in-person) during therapy and examination
Duration - 1 day
Participants undergo surgical exposure with full thickness flaps and root debridement; depending on group allocation, a bone substitute material may be applied to the furcation defect before flap closure.
1 surgical visit (in-person)
Duration - 4 weeks
Participants refrain from mechanical plaque control at the surgical site for 4 weeks and use daily chlorhexidine rinses; sutures are removed after 2 weeks with patient-reported experience collected.
Visits at 2 weeks and 4 weeks (in-person)
Duration - Up to 12 months
Participants receive oral hygiene instructions and supportive periodontal therapy with clinical assessments and patient-reported outcomes evaluated up to 12 months.
Visits at 3, 6, 9, and 12 months (in-person)
Duration - Up to 10 years
Participants are followed for additional clinical and radiographic assessments including furcation closure and bone level changes up to 10 years after surgery.
Visits at 3, 5, 7, and 10 years (in-person)
Trial Site Locations
Total: 1 location
1
Department of Periodontology, Institute of Odontology
Gothenburg, Sweden, 40530
Actively Recruiting
Research Team
J
Jan Derks, PhD
K
Kostas Bougas, PhD
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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