NCT06270303 Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects
| NCT ID | NCT06270303 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Göteborg University |
| Condition | Periodontitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-03-27 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Patients should present with at least one surgically accessible molar (in tooth position 6 or 7) diagnosed with a single furcation defect degree II (at any aspect). Following initial periodontal therapy, teeth to be included should present with one site with furcation defect degree II in combination with: * Bleeding on probing * Probing pocket depth of ≥6 mm * Soft tissue coverage of the furcation entrance Patients should present with a full mouth plaque score ≤25%. Exclusion Criteria: * Multiple deep furcation defects (degree II - III) at the same tooth * Vertical attachment loss \>50% at aspects not facing the furcation defect * Defects presenting with apico-marginal communication * Intake of systemic antibiotics within 6 months * Systemic conditions/medication impeding surgical intervention (e.g. uncontrolled diabetes, immunosuppressive medication)
Contact & Investigator
Karolina Karlsson, PhD
STUDY DIRECTOR
Göteborg University
Frequently Asked Questions
Who can join the NCT06270303 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periodontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06270303 currently recruiting?
Yes, NCT06270303 is actively recruiting participants. Contact the research team at jan.derks@odontologi.gu.se for enrollment information.
Where is the NCT06270303 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT06270303 clinical trial?
NCT06270303 is sponsored by Göteborg University. The principal investigator is Karolina Karlsson, PhD at Göteborg University. The trial plans to enroll 200 participants.