The goal of this proposed treat-to-target clinical trial is to identify a model for personalized delivery of non- surgical periodontal treatment with the objective of improving clinical endpoints. Although the ?one-size-fits- all? non-surgical periodontal therapeutic approach is somewhat effective, studies have shown residual presence of microbial pathogens, and failure to effectively decrease pocket depths to maintainable levels. Such limited efficacy often results in further surgical interventions, detrimentally increasing the cost of out-of-pocket dental care. In this context, antimicrobial strategies with adjunct systemic antibiotics have also been employed suggesting an improved therapeutic response over SRP. Several factors including the reluctance to adopt a therapeutic protocol due to the general caution for antibiotic overuse or misuse especially for non-life threatening infections, have supported the status quo leaving SPR alone as the standard of approach in initial therapy. The purpose of this study is to detect therapeutic strategies with the most favorable clinical outcomes, to characterize the baseline peirodontal microbial communities using high throughput sequencing methodologies and to determine baseline antimicrobial resistance levels. Under the antibiotic stewardship priorities of the White House National Action Plan for Combating Antibiotic-Resistant Bacteria, our goal is to produce empirical evidence on appropriate antibiotic use during the course of non-surgical periodontal therapy. Consequently, we aim to integrate clinical, demographic, medical, microbial data in an analytical model in order to identify predictors of therapeutic response and lay the foundation for individualized therapy following the NIH Precision Medicine framework. In addition, we aim to measure the proportion of baseline resistant isolates and assess their role as predictors of the clinical outcome. Given the complexity of the clinical trial and diversity of outcomes, this application requests funding for a R34 Planning Grant. This phase will offer a unique opportunity to strengthen the multidisciplinary study team, outline the roles and responsibilities and organize the steps of the regulatory aspects of the clinical trial. By the end of the planning phase, all scientific, organizational, administrative, laboratory and clinical instruments and strategies will be developed and finalized.
The 'one-size-fits-all' approach in periodontal therapy has had limited efficacy. The goal of this proposal is to identify patient characteristics including periodontal microbiome and resistance profile that predict the magnitude of treatment response in a treat-to-target model.
