PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Gra

Abstract In this Phase II SBIR project, ASTER Labs will enhance a hands-free automatic oral hygiene device in the form of a comfortable mouthpiece that was designed and successfully tested and evaluated during a Phase I study for persons with oral hygiene disabilities and their caregivers, and then investigate the device’s efficacy in reducing dental plaque and reducing burden, thereby improving quality of life. Many people with neurological, neuromuscular, and developmental disorders, including those suffering physical injury or tremors, are at a higher risk of poor oral health, dental caries, periodontal disease, and soft tissue pathology compared to those without disability. This population of roughly 32 million disabled Americans encounters barriers to routine, comfortable, and effective oral hygiene care, due to problems with grasp, muscle control, range of motion, and reduced dexterity. Many face reduced independence, requiring caregiver assistance to perform daily dental care. These caregivers report great difficulty effectively performing these services due to lack of training, time, or confidence in managing complexities of oral hygiene care. Surveys of current devices to aid these tasks for disabled persons show only limited manual solutions, including props to keep the mouth open and modified toothbrush grips. Current electric toothbrushes require manual control. Inadequate daily hygiene promotes oral disease in the disabled, who are then subject to dental care access barriers due to limited finances, inadequate Medicaid coverage, and a limited pool of professionals trained in disability care. A significant unmet need exists to support better oral hygiene for the disabled and their caregivers with a safe, automatic, affordable, practical solution to promote daily dental care and reduce burden. To address this problem, ASTER Labs, Inc. has developed an effective and novel prototype hands-free automatic system to simplify routine oral hygiene care. The device uses powered moving bristles in a flexible mouthpiece, simply inserted into the mouth to gently remove plaque and debris from teeth and gums. The design includes multiple features to ensure comfort and safety during daily care, including embedded sensors to adjust intensity and speed of the bristle motion. Usage information is wirelessly transmitted to caregivers monitoring care status via an LCD display on a recharging and cleaning base station. These regular reports will promote adherence by preventing disruption in daily hygiene. By providing a technically advanced but practical dental care system for this vulnerable population to use in their homes or care facilities, regular, effective oral hygiene can be improved, reducing risk of preventable oral disease and need for treatment. This Phase II SBIR will evaluate efficacy of this system to provide patients and caregivers with an effective, hands-free method for routine oral hygiene care to improve quality of life, reduce effort and difficulty, and maintain adherence to recommended care. Randomized controlled evaluations will be completed using semi-structured interviews and observation data collected on 110 persons with moderate oral hygiene disabilities, family caregivers, and/or professional care providers.Narrative Individuals suffering from neuromuscular, neurological, or developmental disabilities in the U.S. are at an increased risk of oral disease compared to those without disability, making these individuals’ routine and preventive dental care an extremely important daily task. These individuals and their caregivers frequently report difficulties in performing this task and adhering to effective oral hygiene regimens, leading to increased risk of oral disease stemming from neglect of daily dental care, specifically including tooth decay, periodontal disease, and soft tissue disease, which can result in pain, infection, tooth loss, serious systemic health consequences, and ultimately, diminished quality of life. The proposed research seeks to mitigate this risk by developing a highly effective, easy to use, automatic dental care device to provide regular on-demand in-home or in-facility routine oral hygiene care.