Treatment outcomes of customized oral stent in head and neck radiotherapy

Randomized controlled trial: Comparison of treatment outcomes of head and neck radiotherapy with and without customized intraoral stent

Status

Unknown

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230901003

Enrollment

Registered

2023-09-01

Start date

2022-08-25

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Incidence of radiation-induced oral mucositis (RIOM) grade 2 or more Dosimetric difference between treatment plans with and without IOS intraoral stent radiation-induced oral mucositis head and neck cancer radiotherapy

Interventions

Patient receives radiotherapy with oral stent applied in every fraction. The oral stent was made from the biocompatible, clear, acrylic compound (Stratasys, Germany).,Patient receives radiotherapy wit

Experimental Device,No Intervention No treatment

Intraoral stent,Control

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Head and Neck cancer (including cancers of oral cavity, oropharynx, nasal cavity, paranasal sinus, supraglottic) treated with postoperative or definite radiotherapy with or without chemotherapy 2. Age 20 years or more 3. Radiation dose to target 50 Gy or more

Exclusion criteria

Exclusion criteria: 1. Trismus before radiation 2. Edentulism 3. Previous radiation in head and neck region

Design outcomes

Primary

Measure	Time frame
radiation-induced oral mucositis during radiotherapy upto 8 weeks after completion CTCAE criteria version 5	—

Secondary

Measure	Time frame
Dosimetric difference before treatment Dose comparison	—

Countries

Thailand

Contacts

Public ContactBuntipa Netsawang

Chulalongkorn University

buntipa_nueng@hotmail.com0909522526

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026