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NOT YET RECRUITING
NCT07764887
NA

Impacted Tooth Management and Osteoradionecrosis Risk in NPC

Sponsor: First Affiliated Hospital of Guangxi Medical University

View on ClinicalTrials.gov

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.

Official title: Omission of Prophylactic Impacted Tooth Extraction and Risk of Jaw Osteoradionecrosis in Nasopharyngeal Carcinoma: A Multicenter, Noninferiority, Open-Label, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

536

Start Date

2026-08-30

Completion Date

2032-11-30

Last Updated

2026-08-14

Healthy Volunteers

No

Interventions

OTHER

Omission of Prophylactic Impacted Tooth Extraction

Participants will not undergo prophylactic extraction of eligible impacted teeth before radiotherapy.

PROCEDURE

Prophylactic Impacted Tooth Extraction

Participants will undergo prophylactic extraction of eligible impacted teeth before radiotherapy according to the study protocol.

Locations (11)

Affiliated Hospital of Youjiang Medical University for Nationalities

Baise City, Guangxi, China

Beihai People's Hospital

Beihai, Guangxi, China

Guigang People's Hospital

Guigang, Guangxi, China

The Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Liuzhou People's Hospital

Liuzhou, Guangxi, China

Liuzhou Workers' Hospital

Liuzhou, Guangxi, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Wuming Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, China

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

The First People's Hospital of Yulin

Yulin, Guangxi, China