NCT07764887
Impacted Tooth Management and Osteoradionecrosis Risk in NPC
Registry fields
- Overall status
- NOT_YET_RECRUITING
- Conditions
- Nasopharyngeal Carcinoma (NPC), Osteoradionecrosis of the Jaw
- Study type
- INTERVENTIONAL
- Phase
- NA
- Primary purpose
- PREVENTION
- Intervention type
- OTHER, PROCEDURE
- Interventions
- Omission of Prophylactic Impacted Tooth Extraction, Prophylactic Impacted Tooth Extraction
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University (OTHER)
Cached at: 2026-08-15 00:22:55
Brief summary
This multicenter, randomized controlled trial is designed to determine whether omitting prophylactic extraction of impacted teeth before radiotherapy leads to an unacceptably higher risk of jaw osteoradionecrosis (JORN) compared with conventional prophylactic extraction in patients with non-metastatic nasopharyngeal carcinoma (NPC). JORN is a condition in which jawbone tissue is damaged and fails to heal properly after radiotherapy.
A total of 536 eligible participants with at least one impacted tooth will be randomly assigned to either omit prophylactic extraction of impacted teeth before radiotherapy or undergo conventional prophylactic extraction before radiotherapy. All participants will receive standard curative-intent intensity-modulated radiotherapy (IMRT), with chemotherapy administered when indicated according to the study protocol.
Participants will be followed for up to 5 years. The primary outcome is the incidence of JORN within 2 years after completion of radiotherapy. Secondary outcomes include longer-term incidence of JORN, overall survival, locoregional relapse-free survival, distant metastasis-free survival, quality of life, and treatment-related toxicities.
A total of 536 eligible participants with at least one impacted tooth will be randomly assigned to either omit prophylactic extraction of impacted teeth before radiotherapy or undergo conventional prophylactic extraction before radiotherapy. All participants will receive standard curative-intent intensity-modulated radiotherapy (IMRT), with chemotherapy administered when indicated according to the study protocol.
Participants will be followed for up to 5 years. The primary outcome is the incidence of JORN within 2 years after completion of radiotherapy. Secondary outcomes include longer-term incidence of JORN, overall survival, locoregional relapse-free survival, distant metastasis-free survival, quality of life, and treatment-related toxicities.
Contact
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