NIPH Clinical Trials Search

Prevention of radiation-related caries using high concentration fluoride "F vanish" in patients with pharyngeal cancer: a single-center trial

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Root Caries
Date of first enrollment	26/11/2025
Target sample size	45
Countries of recruitment
Study type	Interventional
Intervention(s)	The application of high concentration fluoride "F vanish" every three month for two years after the completion of radiotherapy.

Outcome(s)

Primary Outcome	The incidence of new radiation-related caries in teeth that were at risk of decay before undergoing radiotherapy
Secondary Outcome	The time until new radiation-related caries appear after finishing radiotherapy

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Intervention group 1. Patients with pharyngeal cancer receive radiotherapy, including that to the cervical lymph nodes bilaterally. 2. Patients will receive concurrent chemoradiotherapy. 3. IMRT is used as the radiotherapy method. 4. Patients can visit the Nagasaki University Hospital every three month for two years after radiotherapy. 5. Patients have more than ten teeth with more than one mm exposure of dentin at the cervical line to obtain consent. 6. Patients are more than 18 years of age. 7. Patients received enough explanation about this research, understood it well, and wrote consent with free will by themselves. Control group 1 1. Patients with pharyngeal cancer completed radiotherapy, including that to the cervical lymph nodes bilaterally, between July 1, 2022, and September 30, 2025, and received oral supportive care at the Oral Management Center. 2. Patients completed concurrent chemoradiotherapy. 3. IMRT was used as the radiotherapy method. 4. Patients were more than 18 years of age at the beginning of oral supportive care. 5. Patients underwent panoramic radiography or dental treatment at Nagasaki University Hospital between more than one year and three years after radiotherapy. 6. Patients had more than ten teeth with no covered biproximal surfaces on panoramic radiography before radiotherapy.
Exclude criteria	Intervention group Patients have Sjogren's syndrome. Patients have a history of allergy to rosin. Patients have ulcerative gingivitis or oral mucositis. The principal investigator or researchers judge that the patient is not suitable as a subject. Patients attend a clinical or other intervention trial. Control group 1 Patients have Sjogren's syndrome. The shape of the teeth is not clear on panoramic radiography. Control group 2 Patients have Sjogren's syndrome. The shape of the teeth was not clear on the panoramic radiography taken before radiotherapy.