Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice

• Status: Recruiting
• Trial end date: 2026-05-26
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Dental PBRN; National Institute of Dental and Craniofacial Research (NIDCR)
• Treatments: Amoxicillin; Metronidazole

Criteria

Inclusion Criteria:

• The study will recruit a target of 544 patient participants presenting for periodontal treatment within the National Dental PBRN practices participating in this study.

To be eligible to participate in this study, a potential patient participant must meet all the following criteria:

• Adult who is at least 40 years old.

• Presence of ≥ 20 permanent teeth excluding 3rd molars.

• In good general health as evidenced by medical history (ASA Class I or II) per the practitioner.

• Planned to receive periodontal care for Generalized Stage II-III, Grade A-C periodontitis (previously Generalized Moderate to Severe Periodontitis) and a minimum of two quadrants of SRP (CDT code 4341) in practices participating in the National Dental PBRN.

• Willing to comply with all study visits and be available for the duration of the study (12-15 months)

• Willing to provide contact information for self, including a cellular phone number for study text, and one to two emergency contacts to be reached for the follow-up visits and any other study-related matters for the duration of the study.

Exclusion Criteria:

• Known drug allergy to any antibiotics or anesthetics.

• Use of systemic antibiotics taken within the previous 3 months prior to enrollment.

• Medical condition which requires antibiotic prophylaxis prior to dental treatments/visits.

• Current use of medications that, in the opinion of the practitioner, may cause adverse effects with AMXM (such as disulfiram, warfarin, and oral contraceptives).

• History of any periodontal therapy (including SRP D4341, D4342) within the last 6 months prior to enrollment.

• Is currently pregnant or lactating per patient participant self-report.

• Is considered immunocompromised, in the opinion of the practitioner (including diseases and conditions such as HIV/AIDS, immunosuppressive drug therapy and/or radiation), or has chronic mucosal lesions (e.g. pemphigus vulgaris) affecting the gingiva.

• Has Diabetes mellitus with an HbA1c score of >/= 10% within the past 3 months as per patient participant self-report.