Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice
Status:
Recruiting
Trial end date:
2026-05-26
Target enrollment:
Participant gender:
Summary
Periodontitis is a bacterial inflammatory disease and antibiotic use is being empirically
used as part of its treatment. However, a clinical practice guideline on periodontal
treatment adjuncts published in 2015 identified weak evidence on the use of systemic
antibiotics and large heterogeneity across small scale studies, suggesting that larger
pragmatic clinical trials would benefit clinical decision making. This will be a prospective,
randomized, placebo-controlled trial, stratified by practice and practitioner. The study will
investigate the effectiveness of adjunctive antibiotics as adjunct to scaling and root
planing (SRP) compared to SRP with placebo for the treatment of generalized stage II-III,
grades A-C periodontitis in approximately 544 patient participants from about 34 National
Dental PBRN practices. Periodontal data will be collected at baseline, re-evaluation (6
weeks), and final (12 months) study visits. Changes in periodontal clinical and
patient-reported outcomes will be assessed to determine the effectiveness of SRP plus
adjunctive systemic Amoxicillin / Metronidazole antibiotics (AMXM) versus SRP with Placebo.
Phase:
Phase 3
Details
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborators:
National Dental PBRN National Institute of Dental and Craniofacial Research (NIDCR)