Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice (NCT06131021) | Clinical Trial Compass
CompletedPhase 3
Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice
United States236 participantsStarted 2024-04-25
Plain-language 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.
Who can participate
Age range
35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The study will recruit 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 35 years old.
* Presence of ≥ 15 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 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) with…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Probing Depth (PD) in millimeters
Timeframe: Baseline to Re-evaluation (6 weeks)
Trial details
NCT IDNCT06131021
SponsorRutgers, The State University of New Jersey