Dentist-led systematic oral education programs in the prevention of radiation-induced oral toxicities in patients with head and neck cancer (BRIGHT): A randomized clinical trial.

Abstract

12144 Background: Radiotherapy-induced oral toxicity (RIOT) is a common complication in patients with head and neck cancer (HNC). International guidelines have recognized the role of oral-health education in preventing RIOT. However, most recommendations remained at the level of general principles and lacked a detailed, systematic and operationalized process, which hinders effective clinical delivery of oral-health education. Given that dentists are uniquely positioned to manage oral health, this study aims to evaluate the effectiveness of a dentist-led systematic oral-health education program (OHEP) on RIOT and provide a standard operating procedure (SOP) for its implementation. Methods: In this single-centre, assessor-blinded, randomised controlled trial, 150 patients with non-metastatic HNC scheduled for definitive radiotherapy (60–72 Gy) were enrolled at West China Hospital in China. Participants were randomly assigned (1:1) to receive either a dentist-led oral health education program (OHEP) or routine oral health care. The primary endpoint was the incidence of oral mucositis (OM), assessed by the WHO Oral Mucositis Grading Scale. Secondary endpoints included the incidence of severe oral mucositis (SOM, defined as WHO grade 3–4) as well as the time to onset and duration of OM (SOM). Outcome assessments were conducted by trained research assistants blinded to group allocation. Analyses were performed in both intention-to-treat and per-protocol populations, with two-sided P < 0.05 considered statistically significant. This study is registered with ClinicalTrials.gov, NCT06690346, and is now complete. Results: Of 150 randomised patients, 75 were allocated to each arm, and 142 (94.7%) completed the trial and were included in the intention-to-treat analysis. The incidence of OM was significantly lower in the OHEP arm than in the control arm (70.7% [53/75] vs. 88.0% [66/75] P = 0.016), with a significantly delayed onset (median 17 vs. 14 days; P = 0.006) and shorter duration (median 39 vs. 60 days; P < 0.001). Consistent results were observed in the per-protocol population. However, no significant difference was observed in the incidence, onset, or duration of SOM between arms. Conclusions: Dentist-led OHEP significantly reduced the incidence and delayed the onset of radiotherapy-induced OM. These results support dentist-led OHEP as a feasible, non-pharmacological approach to mitigate oral toxicity and improve supportive care in patients receiving radiotherapy for HNC. Clinical trial information: NCT06690346 .