PRIMAL THERAPIES INC — Department of Health and Human Services SBIR Phase I: N

Description

Project Abstract By million Americans will be over the age of Currently of older adults have periodontal disease have untreated tooth decay and in older adults have lost some or all of their teeth This poses a significant problem as mounting evidence demonstrates a link between oral disease and systemic life threatening diseases including premature death Gum disease inflammation and bleeding gums is associated with systemic conditions such as cardiovascular disease stroke diabetes mellitus chronic kidney disease respiratory disorders dementia and oral throat and pancreatic cancers Moreover numerous studies suggest that the number of teeth lost in adulthood is a predictor of premature death Therefore an individualandapos s oral health and general systemic health are tightly linked and good oral hygiene could be an easy means of preventing serious life threatening conditions in many older adults The most significant driver of oral disease is dysbiosis which is a disturbance in the balance that exists amongst the microbes in the mouth wherein the burden of pathogens reaches disease causing levels and the levels of health promoting bacteria are too low to compensate The most characterized oral pathogens include the cavity causing Streptococcus mutans and the gum disease associated P gingivalis T denticola and T forsythia We have identified a means of inhibiting the pathogenic metabolism of these bacterial pathogens through the use of a naturally safe GRAS ingredient combination PTx which has been shown to i inhibit pathogen growth while preserving health promoting bacterial growth ii block pathogen sugar metabolism and iii inhibit acid and iv plaque production in in vitro studies Further studies in humans aged confirmed the selective anti pathogen effects of PTx while preserving Lactobacillus levels and improved oral pH balance in a sustained manner For many older adults decreased manual dexterity physical or mental impairment income constraints lack of dental insurance all contribute to and exacerbate oral disease We believe we have a cost effective nontoxic and easy to take oral solution in PTx rapid dissolving lozenges We propose to confirm our PTx pilot data and to evaluate its performance and ease of use in the older adult population who frequent elderly community centers in the greater Cleveland Ohio area We will assess the and week efficacy of PTx as a supplement to standard oral hygiene practices in a cohort of participants who have confirmed dental pathogens and clinical gingivitis and compare the change in disease scores and pathogen burdens over time As a part of the study design we will also survey this population for perceptions biases and habits as they relate to oral health social and emotional wellbeing The culmination of this work will enable us to better understand and address the oral health crisis in older adults as well as to evaluate the impact our approach may have in improving quality of life for this demographic Project Narrative By million Americans will be over the age of Currently of older adults have periodontal disease have untreated tooth decay and in older adults have lost some or all of their teeth This poses a significant problem as mounting evidence demonstrates a link between oral disease and systemic life threatening disease including premature death This proposal focuses on evaluating the clinical disease impact of our oral care lozenge previously shown to selectively decrease gum disease causing bacteria while leaving health promoting bacteria intact We propose to explore its translation to the older adult population with particular focus on vulnerable subpopulations with established health disparities This work will also uncover perceptions biases and dental hygiene practices for this demographic as well as to establish the potential impact our approach may have in improving quality of life for older adults