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NCT06131021 · ClinicalTrials.gov registry record · Phase 3
Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice
A Phase 3 study of Periodontal Diseases and Periodontitis, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06131021: Recruiting Phase 3 study of Periodontal Diseases and Periodontitis, sponsored by Rutgers, The State University of New Jersey.
NCT06131021 is a Phase 3 study of Periodontal Diseases and Periodontitis that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 150 participants, roughly in line with the 152-participant average among 15 other Periodontal Diseases trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06131021, a Phase 3 study of Periodontal Diseases and Periodontitis, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The primary outcome of treatment effectiveness will be assessed by full-mouth probing depth (PD) from baseline to 6 weeks following intervention. Full-mouth PD measurements (excluding 3rd molars) will be obtained utilizing a UNC 15mm periodontal probe.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Amoxicillin
- DRUG Metronidazole
Study Locations (1)
Alabama
- University of Alabame - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-04-25 |
| Est. Completion | 2026-05-26 |
| Phase | Phase 3 |
What NCT06131021 shows while recruiting
NCT06131021 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 152-participant average among 15 other Periodontal Diseases trials with a reported enrollment target.
The record links to 3 conditions, with Periodontal Diseases appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06131021 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06131021 about?
NCT06131021 is a clinical study titled "Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice". 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 acro...
What is the current status of trial NCT06131021?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2024-04-25. Estimated completion is 2026-05-26.
What conditions does trial NCT06131021 study?
This clinical trial studies the following conditions: Periodontal Diseases, Periodontitis, Periodontal Pocket.
What interventions are being tested in trial NCT06131021?
The interventions under investigation include: Placebo (OTHER), Amoxicillin (DRUG), Metronidazole (DRUG).
Who is sponsoring clinical trial NCT06131021?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06131021 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Periodontal Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06131021's enrollment target sits among peer trials
150 5th of 15 higher than 11 of 15 other Periodontal Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Periodontal Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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