drugset / Trial / NCT06131021

Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice

NCT06131021

RandomizedParallel-groupDouble-blindTreatment

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 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.

Timeline

Start
2024-04-25
Primary completion
2026-04-07
Completion
2026-04-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 500 mg Oral
Subject Metronidazole Small molecule 500 mg Oral

Indications