Shaping the Indications for Periodontal Adjunctive Antibiotics in dental practice: A PBRN Clinical Trial
Periodontitis is a bacterial inflammatory disease that has been reported to affect nearly 40% of Americans
aged 30 years or older. If left untreated, periodontitis can lead to tooth loss and patient-perceived morbidity.
Historically, antibiotic use has been an integral part of periodontal disease treatment. However, antibiotic
stewardship calls for rationalizing their prescription to reduce antibiotic misuse and development of resistant
strains. Across medical disciplines, there is a clear direction to identify individuals who in fact may benefit
from antibiotic use and to provide guidelines for their use. As of 2018, the American Dental Association has
developed evidence-based guidelines limiting circumstances for prophylactic antibiotic use in dental
practice; however, no national guidelines exist for antibiotic use in treatment of periodontal infections
because of lack of adequately powered trials assessing disease- and person-specific indications. Thus,
dentists are left to decide when adjunctive antibiotics are indicated, and which dental patients need them to
achieve periodontal health. In the context of periodontitis treatment, a biological rationale exists to support
adjunctive antibiotic use against periodontal pathogenic bacteria, but clinical results of their use have
presented conflicting results. Currently, very limited documentation of the prescription patterns and utilization
of antibiotics as periodontal treatment adjuncts among US practitioners exist. Nonetheless, data from
academic studies suggest that adjunctive systemic antibiotics may only be beneficial for certain populations,
as the biological response to treatment is highly variable across individuals. This marked variability warrants
the identification of person- and/or disease-related characteristics that are linked to maximum benefit from
adjunctive antibiotic treatment. Consequently, clear guidelines can then be established for tailored
indications for their use with the ultimate goal of minimizing antibiotic misuse in periodontal treatment to
avoid development of antibiotic resistance. The objective of this study is to assess the effectiveness of
adjunctive Amoxicillin/Metronidazole combination antibiotics to non-surgical periodontal therapy in clinical
practices within the National Dental PBRN by conducting the largest randomized clinical trial (RCT) of
adjunctive antibiotics. Further, within this PBRN study, current decision-making factors for adjunctive
antibiotic prescription will be surveyed to assess the state of affairs in clinical practice. Importantly,
leveraging the well-powered RCT dataset, high responders to adjunctive antibiotic treatment will be identified
and the predictive validity of decision-making factors currently employed by clinicians will be assessed to
develop clear indications for prescription. Collectively, results of adjunctive antibiotic use at present are
ambiguous because indications are based on empirical information without evidence-based guidelines,
which may lead to antibiotic misuse and lack of efficacy. The present pragmatic well-powered RCT was
designed to enable the development of evidence-based guidelines for periodontal adjunctive antibiotic use.
