Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects
Launched by GÖTEBORG UNIVERSITY · Feb 13, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment option for people with gum disease, specifically those who have a type of problem called "furcation defects" in their molar teeth. The researchers want to find out if adding a special bone substitute material during surgery can help improve the healing of these defects compared to just cleaning the area through a procedure called open-flap debridement. In total, 200 patients who have at least one molar with a degree II furcation defect will be enrolled. They will be randomly assigned to either the standard treatment or the treatment that includes the bone substitute. The main goal is to see if the furcation area can heal properly, along with checking other factors like bleeding and overall gum health.
To be eligible for this trial, participants should have at least one molar with a furcation defect that is accessible for surgery and have certain signs of gum disease, like bleeding when probing and a deep pocket around the tooth. However, those with more severe defects, certain medical conditions, or recent antibiotic use won’t be included. Participants can expect to undergo surgery and will be monitored for healing and any side effects. This trial is currently recruiting patients of all genders between the ages of 65 and 74.
Gender
ALL
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)
About Göteborg University
Göteborg University, a leading academic institution in Sweden, is committed to advancing healthcare through innovative research and clinical trials. With a strong focus on interdisciplinary collaboration, the university leverages its extensive expertise in various fields, including medicine, pharmacology, and social sciences, to address pressing health challenges. By sponsoring clinical trials, Göteborg University aims to contribute to the development of new therapies and improve patient outcomes, while adhering to the highest ethical standards and regulatory requirements. Their dedication to rigorous scientific inquiry and community engagement positions them as a pivotal player in the global health research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Göteborg, , Sweden
Patients applied
Trial Officials
Karolina Karlsson, PhD
Study Director
Göteborg University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported