Periodontitis is a common chronic inflammatory disease characterized by destruction of the supporting structures of the teeth (the periodontal ligament and alveolar bone). The total prevalence of periodontitis in adults aged 30 years and older was 47.2% (representing about 64.7 million adults aged 30 years and older) and 70.1% in adults aged 65 years and older in the U.S. Epidemiological data confirm that diabetes is a major risk factor for periodontitis; susceptibility to periodontitis is approximately fivefold higher in people with diabetes. In the USA alone 29.1 million people (9.3% of the U.S. population) have diabetes. Currently worldwide diabetic population stands at 422 million and it is estimated that by 2040 this number will increase to 642 million. Periodontitis is highly prevalent in diabetes and has multiple negative impacts on quality of life. The current treatment option for periodontal diseases involves mechanical debridement ? scaling and root planning and sometime followed by adjunctive therapy such as local delivery of antimicrobials (e.g., Periochip) or systemic antibiotics such as doxycycline. The antimicrobials? disadvantages include: antimicrobial resistance, failure to penetrate beyond biofilm surface layer, and systemic side effects. Surgical treatment is painful and requires frequent and multiple visits to the dentist. Other limitation of current treatment is that none of these drugs are targeting host and periodontal bone loss. There is a major void in periodontal disease therapeutics products which can target host response and easy to use. The global periodontal disease therapeutics market is anticipated to gain a growth of 8.7% from 2016 to 2024. At this pace, the market is estimated to reach a valuation of US$537.2M by the end of the forecast period. Periomics Care is an early-stage New York based biotechnology company that was established to commercialize a novel oral strip or gel formulation for treatment of periodontal disease specifically for Type 2 diabetic population. With NYU College of Dentistry, Periomics Care propose to develop sustained-release antagonist formulation to target succinate receptor (SucnR1), the method is protected by provisional US patent. The premise of this proposal is based on our recent findings that succinate, a Krebs cycle intermediate is elevated in diabetes and activates SucnR1 to stimulate osteoclastogenesis. We further demonstrated that blocking SucnR1 activation by a synthetic antagonist controls inflammation and periodontal bone loss. We proposed to develop strip/film and gel formulations based on biodegradable material impregnated with SucrR1 antagonist which can be implanted by dentist or used as local tropical gel over gingival tissue by consumers. The funds gained from this STTR grant will be used to (1) develop and optimize the formulation, (2) test and determine the efficacy of the formulation in periodontal animal model. The outcomes from this study will help the company move the optimal formulation into Phase II translational studies for treatment and prevention of periodontal disease.
Periodontal disease cause functional limitation and impact is significantly associated with age. Moreover chronic periodontal disease is associated with other systemic disease. The treatment options are invasive, painful and not always successful which results in tooth loss. The impact to society is burdensome as patients suffer a compromised life quality. The development of a biodegradable oral strip or gel formulation that could be administered through less invasive approaches to augment or replace the conventional treatment could prove to be a major step forward in the treatment of periodontal disease.
