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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs072250101
Enrollment
45
Registered
2025-11-26
Start date
2025-11-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Root Caries radiation-related caries

Interventions

The application of high concentration fluoride "F vanish" every three month for two years after the completion of radiotherapy.
C514043
high concentration fluoride "F vanish"

Sponsors

Kawashita Yumiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
The incidence of new radiation-related caries in teeth that were at risk of decay before undergoing radiotherapy

Secondary

MeasureTime frame
The time until new radiation-related caries appear after finishing radiotherapy

Contacts

Public ContactYumiko Kawashita

Nagasaki University Graduate School of Biomedical Sciences

yumiko-t@nagasaki-u.ac.jp+81-958197663

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026