Evaluation of the efficacy of low concentration fluoride gel using custom trays to prevent radiation-related dental caries in patients with head and neck cancer: protocol for a randomised controlled phase III trial (FluCar study).

This study was approved by the Clinical Research Review Board in Nagasaki University The protocol of this study was registered at Japan Registry of Clinical Trials (jRCT) and University hospital Medical Information Network Clinical Trials Registry (UMIN). The datasets generated during the current study will be available from the corresponding author on reasonable request. TRIAL REGISTRATION NUMBERS: jRCTs 072190039 and UMIN000041426.