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RECRUITING
NCT06131021
PHASE3

Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

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

DRUG

Amoxicillin

Amoxicillin belongs to the penicillin category, and it is a commonly prescribed broad-spectrum antibiotic as a periodontal treatment adjunct.

DRUG

Metronidazole

Metronidazole is effective against anaerobic bacteria, and it is often combined with Amoxicillin for an enhanced antimicrobial effect as a periodontal treatment adjunct.

OTHER

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