Status:
RECRUITING
Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
National Dental PBRN
Conditions:
Periodontitis
Periodontal Diseases
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief 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 publis...
Detailed Description
Précis: 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 adjunct...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 26 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06131021
Start Date
April 25 2024
End Date
May 26 2026
Last Update
August 11 2025
Active Locations (1)
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1
University of Alabame
Birmingham, Alabama, United States, 35233