Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice

Launched by RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY · Nov 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of adding antibiotics to standard dental treatment for people with a type of gum disease called periodontitis. Specifically, the researchers want to see if using antibiotics alongside a cleaning procedure known as scaling and root planing (SRP) can improve treatment outcomes compared to SRP alone. The trial will involve about 544 participants from dental practices across the nation, focusing on patients who have stage II-III periodontitis and meet certain health criteria.

To be eligible for this study, participants need to be adults aged 40 or older, must have at least 20 permanent teeth, and should be in generally good health. They will need to be willing to attend multiple study visits over a period of 12 to 15 months. Throughout the trial, participants will be monitored to assess their gum health and any changes in their condition. It's important for potential participants to know that certain medical conditions or recent antibiotic use may exclude them from the study. If you think you might be eligible or are interested in contributing to this research, please reach out to your dental provider for more information.

Gender

ALL

Eligibility 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.