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An open-label, randomized controlled study of the manufacturing efficiency and clinical performance of digital radiotherapy prostheses for patients undergoing brachytherapy for tongue cancer

An open-label, randomized controlled study of the manufacturing efficiency and clinical performance of digital radiotherapy prostheses for patients undergoing brachytherapy for tongue cancer

Murase Mai

Institute of Science Tokyo Hospital

1-5-45,Yushima, Bunkyo-ku, Tokyo

maiiam.mfp@tmd.ac.jp

Murase Mai

Institute of Science Tokyo Hospital

1-5-45,Yushima, Bunkyo-ku, Tokyo

+81-3-5803-5720

maiiam.mfp@tmd.ac.jp

Recruiting

April. 07, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Tongue cancer patients scheduled for brachytherapy (regardless of primary or recurrent disease)
2. Patients having stable occlusion with at least one occlusal unit on each side supported by residual teeth, totaling three or more occlusal units
3. Patients with sufficient space (at least 10mm) between the treatment area and mandible for prostheses placement
4. Patients with a maximum mouth opening of 30mm or greater
5. Patients aged 20 years or older at the time of consent acquisition
6. Patients who have provided written informed consent to participate in this clinical study

1. Patients with mobile teeth preventing impression taking using impression materials
2. Patients requiring urgent treatment for whom the necessary laboratory processing time cannot be secured
3. Patients with significant oral pain that interferes with impression taking
4. Patients with a history of hypersensitivity to the dental materials used
5. Patients with communication difficulties due to cognitive impairment or other conditions
6. Other patients deemed unsuitable for participation in this study by the principal investigator (or co-investigator)

Both

Tongue cancer

Patients scheduled for brachytherapy for tongue cancer will be assigned to either the study group or the control group. In the study group, radiotherapy prostheses will be fabricated using digital methods, while in the control group, radiotherapy prostheses will be fabricated using conventional methods.

Dental Treatment Time for radiotherapy prostheses fabrication

1. Success rate in fabricating radiotherapy prostheses
2. Patient burden during the fabrication of radiotherapy prostheses (measured using the VAS)
3. Adjustment amount of radiotherapy prostheses
4. Technician working time required for fabrication of radiotherapy prostheses
5. Time required for impression taking and bite registration for fabrication of radiotherapy prostheses
6. Degree of discomfort during impression taking and bite registration (measured using the VAS)

+81-3-5803-4574

Feb. 20, 2026

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