3D imaging cone beam computed tomography versus orthopantomogram to improve the oral health status of patients hospitalized for infective endocarditis (3D STARS): study protocol of a randomized superiority controlled trial.

BACKGROUND: Infective endocarditis (IE) is a serious and costly infectious disease associated with high morbidity and mortality. The oral cavity is the second most common source of IE accounting for approximately 30% of cases. Detection and management of oral infectious foci (OIF) are therefore critical to reduce IE incidence, relapse or recurrence. Current guidelines recommend the systematic detection and elimination of OIF in IE patients through clinical oral examination and orthopantomogram (OPT). Despite these recommendations, the annual incidence of IE has remained stable. Cone Beam Computed Tomography (CBCT), offers significantly improved diagnostic accuracy over OPT for the detection of OIF. For this randomized clinical trial (RCT), we hypothesize that in IE patients, systematic evaluation using CBCT would identify more OIF than OPT, thereby improving oral health status and potentially reducing the risk of IE recurrence. METHODS: This is a prospective, 2-parallel arms, superiority and individual-based RCT. The main objective is to compare the efficacy of two personalized management strategies on IE patient’s oral health status at 12 months regardless of the microorganism responsible for IE. We hypothesize that the experimental strategy based on clinical oral examination combined with CBCT is superior to the reference strategy based on clinical oral examination combined with OPT, performed at the time of IE. The primary endpoint is a “perfect” oral health status defined as a complete absence of OIF on CBCT performed in all patients combined with clinical examination at 12 months. 170 patients meeting the inclusion criteria will be enrolled. This number was calculated based on preliminary assumptions of the main criterion. Analyses will be conducted on data from the modified intention-to-treat population and the per-protocol population. DISCUSSION: The data generated by this study may improve the therapeutic management of patients with IE and potentially decrease the rate of IE recurrence. This should enable cost/effectiveness studies to be conducted on the prevention of IE. In addition, the recommendations for good practice and the training of healthcare professionals involved in the management of patients with IE could be updated with data of high level of evidence. TRIAL REGISTRATION: ClinicalTrials.gov (NCT06269679 on February 13td, 2024).