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Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice
Sponsor: Rutgers, The State University of New Jersey
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 patient participants from National Dental PBRN practices. Periodontal data will be collected at baseline, re-evaluation (6 weeks), and final (4-12 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.
Official title: Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice: A PBRN Clinical Trial
Key Details
Gender
All
Age Range
35 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-04-25
Completion Date
2026-05-26
Last Updated
2025-08-11
Healthy Volunteers
Yes
Interventions
Amoxicillin
Amoxicillin belongs to the penicillin category, and it is a commonly prescribed broad-spectrum antibiotic as a periodontal treatment adjunct.
Metronidazole
Metronidazole is effective against anaerobic bacteria, and it is often combined with Amoxicillin for an enhanced antimicrobial effect as a periodontal treatment adjunct.
Placebo
Placebo in identical drug-safe vials with capsules identical in appearance to the active drugs
Locations (1)
University of Alabame
Birmingham, Alabama, United States