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

StatusRecruiting
PhaseNot applicable
Started2025-03-27
View on ClinicalTrials.gov ↗

Amendment history

2025-08-20
minor
Study Status v3
Re-verified, no change to tracked fields
2025-03-11
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-12-01→2028-03-01
Completion date2036-12-01→2037-03-01
Start date2024-12-01→2025-03-27
Study sitesdetails revised at 1 of 1 site
2024-09-26
minor
Study Status v1
Primary completion date2027-03-01→2027-12-01
Completion date2036-03-01→2036-12-01
Start date2024-03-01→2024-12-01
2024-02-13
minor
Original filing
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.
Trial Details
NCT Number NCT06270303
Lead Sponsor Göteborg University
Collaborators: Johann Wolfgang Goethe University Hospital, Charite University, Berlin, Germany, King's College London, Queen Mary University of London, Geistlich Pharma AG, Vastra Gotaland Region
Conditions Periodontitis, Furcation Defects
Enrollment 200 participants
Start Date 2025-03-27
Primary Completion 2028-03-01 (estimated)
Study Completion 2037-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-21