Using antibiotics to improve periodontal treatment outcomes
Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice: A PBRN Clinical Trial
This study is testing if adding antibiotics to standard gum treatment can help people with moderate to severe gum disease feel better and improve their dental health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 544 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06131021 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of adjunctive antibiotics, specifically Amoxicillin and Metronidazole, in combination with scaling and root planing (SRP) for treating generalized stage II-III periodontitis. It is a prospective, randomized, placebo-controlled trial involving approximately 544 participants from 34 National Dental PBRN practices. The study aims to assess changes in periodontal probing depth and patient-reported outcomes at baseline, 6 weeks, and 12 months after treatment. The findings will help clarify the role of antibiotics in periodontal therapy and inform clinical decision-making.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with generalized stage II-III, grades A-C periodontitis who are scheduled for periodontal treatment.
Not a fit: Patients with fewer than 20 permanent teeth or those not in good general health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for periodontitis, enhancing patient outcomes and potentially reducing the severity of the disease.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of adjunctive antibiotics in periodontal treatment, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama
- University of Alabame — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Georgios Kotsakis, DDS — Rutgers University
- Study coordinator: Varvara Chrepa, DDS, PhD
- Email: vc551@sdm.rutgers.edu
- Phone: 973-972-7331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.