Minimally-invasive treatment for bone defects in gum disease

Analysis of Intrabony Defects Treated With Minimally-invasive Non-surgical Therapy: A Prospective Cohort Multicentre Study

This study is testing a new, less invasive treatment for gum disease that aims to help people with deep bone defects in their gums without needing surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Queen Mary University of London (other)
• Locations: 9 sites (Brisbane and 8 other locations)
• Trial ID: NCT03741374 on ClinicalTrials.gov

What this trial studies

This investigation evaluates the clinical and radiographic outcomes of treating intrabony defects associated with chronic periodontitis using a minimally-invasive non-surgical therapy. The approach focuses on reducing bacterial load and promoting periodontal regeneration without the need for surgical intervention, which can be costly and unpredictable. Participants will undergo a treatment regimen that includes oral hygiene instructions and non-surgical periodontal therapy, specifically targeting deep intrabony defects. The study aims to provide a less invasive alternative to traditional surgical methods for managing periodontal disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with a diagnosis of periodontitis and at least one intrabony defect.

Not a fit: Patients with a history of smoking, serious medical conditions, or those requiring prophylactic antibiotic coverage may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer patients a safer and more effective way to manage chronic periodontitis and prevent tooth loss.

How similar studies have performed: Other studies have shown promise with minimally-invasive approaches for periodontal treatment, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Age 18-70
2. Diagnosis of Periodontitis (Tonetti et al. 2018)
3. Presence of ≥1 'intrabony defect' (PPD and CAL \>5 mm with radiographic intrabony defect depth ≥3mm and not in a site associated with furcation involvement)
4. Signed informed consent \[Participants must be able and willing to read and sign a copy of the "Informed Consent Form" (ICF) form after reading the "Patient Information Leaflet" (PIS), and after the nature of the study has been fully explained\].

Exclusion Criteria:

1. Smoking (current or in past 5 years, including electronic cigarettes, vaping or similar)
2. Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases
3. Presence of drug-induced gingival enlargement
4. History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
5. Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam
6. Systemic antibiotic therapy during the 3 months preceding the baseline exam,
7. Taking immunosuppressant medications
8. Known allergy to local anaesthetic
9. History of alcohol or drug abuse
10. Self-reported pregnancy or lactation
11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that according to the investigator may increase the risk associated with trial participation
12. Periodontal treatment to the study site within the last 12 months (excluding not-extensive subgingival debridement as judged by the examining clinician).

Where this trial is running

Brisbane and 8 other locations

• Dr Ryan Lee Private Practice — Brisbane, Australia (RECRUITING)
• Studio Dentistico Associato Montevecchi D'Alessandro — Forlimpopoli, Italy (NOT_YET_RECRUITING)
• Clinica de Periodoncia — Coruna, Spain (NOT_YET_RECRUITING)
• South Coast Dental Specialists — Dorchester, United Kingdom (NOT_YET_RECRUITING)
• The Dentist — London, United Kingdom (RECRUITING)
• High Barnet Dental Care — London, United Kingdom (RECRUITING)
• Pall Mall Dental — London, United Kingdom (RECRUITING)
• Ravenscourt Dental Practice — London, United Kingdom (RECRUITING)
• Claremont Dental Practice — Middlesex, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Luigi Nibali, DipDent, MSc, PhD — Barts & The London School of Medicine & Dentistry, QMUL
• Study coordinator: Luigi Nibali, DipDent, MSc, PhD

Conditions: Chronic Periodontitis