Assess A Smartphone App (AICaries) that uses artificial intelligence to detect dental caries in children and provide interactive oral health education: Protocol for design and usability testing (Preprint)

BACKGROUND Early childhood caries (ECC) is the most common chronic childhood disease, with nearly 1.8 billion new cases per year globally. ECC afflicts approximately 55% of low-income and minority US preschool children, resulting in harmful short- and long-term effects on health and quality of life. Clinical evidence shows that caries is reversible if detected and addressed in its early stages. However, many low-income US children often have poor access to pediatric dental services. In this underserved group, dental caries is often diagnosed at a late stage when extensive restorative treatment is needed. With more than 85% of lower-income Americans owning a smartphone, mHealth tools, such as smartphone application, hold great promise to achieve patient-driven early detection and risk control of ECC. OBJECTIVE This study aims to employ a community-based participatory research strategy to refine and test the usability of an artificial intelligence (AI) -powered smartphone app, AICaries, to be used by children's parents/caregivers for dental caries detection in their children. METHODS Our previous work has led to the prototype of AICaries, which offers AI-powered caries detection using photos of children's teeth taken by the parents' smartphones, interactive caries risk assessment, and personalized education on reducing children's ECC risk. This AICaries study will utilize a 2-step qualitative study design to assess the feedback and usability of the app component, app flow and whether parents can take photo of children’s teeth on their own. Specifically, in Step 1, we will conduct individual usability tests among 10 pairs of end-users (parents with young children) to facilitate app module modification and fine-tuning using Think-aloud and Instant Data Analysis strategies. In Step 2, we will conduct unmoderated field testing for app feasibility and acceptability among 32 pairs of parents with their young children to assess the usability and acceptability of AICaries, including assessing the number/quality of teeth images taken by the parents for their children and parents’ satisfaction. RESULTS The study is funded by the National Institute of Dental and Craniofacial Research, USA. This study received IRB approval and launched in August, 2021. Data collection and analysis are expected to conclude by March 2021 and June 2022, respectively. CONCLUSIONS Using AICaries, parents can use their regular smartphones to take photo of their children’s teeth and detect ECC aided by AICaries, so that they can actively seek treatment for their children at an early and reversible stage of ECC. Using AICaries, parents can also obtain essential knowledge on reducing their children's caries risk. Data from this study will support future clinical trial that evaluates the real-world impact of using this innovative smartphone app on early detection and prevention of ECC among low-income children.