Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06270303

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Department of Periodontology, Institute of Odontology

Gothenburg, Sweden, 40530

Actively Recruiting

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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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