Comparing non-surgical and surgical treatments for gum disease-related tooth issues
Survival of Molars With Degree III Periodontal Furcation Involvement Following Non-surgical or Surgical Therapy: a Multicentre Single-masked Superiority Randomised Controlled Trial.
This study is testing whether non-surgical or surgical treatments work better for people with gum disease-related tooth problems to see which one helps keep their teeth healthier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05237401 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of non-surgical periodontal treatment versus surgical procedures for patients with furcation involvement due to severe periodontitis. Patients will be recruited from various periodontal clinics across the UK, Germany, Sweden, Spain, Italy, and Australia. Eligible participants will undergo either non-surgical or surgical interventions, with their progress monitored over approximately five years. The study seeks to determine which treatment modality offers better outcomes in managing furcation defects and preventing tooth loss.
Who should consider this trial
Good fit: Ideal candidates include individuals with severe periodontitis and specific furcation involvement in molars who have received prior non-surgical therapy.
Not a fit: Patients with high plaque scores, recent antibiotic use, or those on long-term periodontal management plans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines for treating patients with furcation involvement, potentially improving tooth retention and overall oral health.
How similar studies have performed: Previous studies have explored various treatment modalities for periodontal issues, indicating that surgical approaches can be effective, but this specific comparison of non-surgical versus surgical treatment for furcation involvement is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minimum of 12 teeth present * Diagnosis of Severe Periodontitis stage III or IV * At least one maxillary/ mandibular molar with: i) degree III horizontal furcation involvement (at least between 2 roots for maxillary molars) , ii) class B vertical furcation involvement (bone loss up to the middle third of root cones), iii) residual probing pocket depths \> 5 mm in furcation area, iv) maximum mobility degree Iand v) not already accessible for self-performed oral hygiene * Received a course of non-surgical periodontal therapy within the past six months Exclusion Criteria: Patient: * Full mouth plaque score \> 30% * A course of antibiotics within the past 3 months * Pregnant/lactating women * Relevant medical history as evaluated by the examining clinician which may have the potential to affect periodontal surgical treatment * Individuals on long-standing (2 or above years) supportive periodontal therapy (SPT) management plans Molar affected by FI: * Ongoing endodontic pathology affecting the furcation involved molar, as judged by the examining clinician * Previous periodontal surgical treatment to the furcation affected molar within the previous 5 years * Endodontically treated molar tooth without a full coverage restoration * 'Unrestorable' molar tooth (lacking adequate tooth structure to provide a restoration) as deemed by the examining clinician. * Molar tooth acting as a bridge abutment * The presence of occlusal dysfunction as assessed by the examining clinician
Where this trial is running
London
- King's College London — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Luigi Nibali
- Email: luigi.nibali@kcl.ac.uk
- Phone: 3701093729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.