Diagnostic performance of two teledentistry tools in elderly care facilities: the ONE-1 protocol for a pilot prospective diagnostic study.

INTRODUCTION: Elderly people living in care facilities suffer from difficulties in accessing preventive and curative dental care. This leads to poor oral health, which is an increased risk of systemic diseases, in a fragile and dependent population. All this contributes to a progressive loss of autonomy and a decreased quality of life. The use of information and communication technologies through oral telemedicine could help to overcome these barriers. We described the protocol for evaluating the diagnostic performance of two intraoral cameras against a gold standard clinical examination. METHODS AND ANALYSIS: We conduct a pilot multicentric and prospective diagnostic study (a minimal-risk, minimal-burden interventional research called ONE-1 (for Oral graNd Est step 1)) on two intraoral diagnostic tools (Soprocare camera and consumer camera) compared with a reference intraoral examination. Patients in four elderly care facilities will be included, with randomisation of participant selection and randomisation of the order of the three intraoral examinations performed by a dental surgeon. We will evaluate the diagnostic performance of each device with the asynchronous analysis of videos by two independent dental surgeons against the clinical gold standard examination performed by a single, third dental examiner. The primary outcome is the presence of at least one tooth decay in the dentition of each study participant. Second, we will evaluate the presence of other dental or oral diseases, and the time required to perform each examination. Finally, we will evaluate the organisation of patient follow-up. ETHICS AND DISSEMINATION: The protocol has been approved by the French ethics committee (Protection to Persons Committee, Nord-Ouest IV on 9 June 2021 and on 28 November 2022). Results will be disseminated through conferences' presentations and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05089214.