Not Yet RecruitingNot Applicable

Impacted Tooth Management and Osteoradionecrosis Risk in NPC

China536 participantsStarted 2026-08-30

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Age 18-75 years, regardless of sex. * Histologically confirmed non-keratinizing nasopharyngeal carcinoma, including differentiated or undifferentiated subtype (WHO type II or III). * Newly diagnosed, previously untreated nasopharyngeal carcinoma with stage T1-4N0-3M0 according to the 9th edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system. * Presence of permanent dentition with at least one impacted third molar. * Adequate bone marrow function, defined as white blood cell count ≥4.0 × 10⁹/L, platelet count ≥100 × 10⁹/L, and hemoglobin ≥90 g/L. * Adequate hepatic function, defined as alanine aminotransferase and aspartate aminotransferase ≤2.5 × the upper limit of normal (ULN), and total bilirubin ≤1.5 × ULN. * Adequate renal function, defined as blood urea nitrogen and serum creatinine ≤1.5 × ULN, or creatinine clearance ≥60 mL/min. * Coagulation function within normal limits. * Written informed consent provided, with willingness and ability to comply with study visits, treatment plans, laboratory assessments, and other study procedures. Exclusion Criteria: * Histopathological diagnosis other than WHO type II or III nasopharyngeal carcinoma. * Impacted third molars with recurrent pericoronitis or inflammation due to incomplete eruption. * Fully erupted third molars with dental caries involving the pulp. * Impacted thir…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

2-Year Cumulative Incidence of Jaw Osteoradionecrosis

Timeframe: Within 24 months after completion of radiotherapy

Trial details

NCT IDNCT07764887

SponsorFirst Affiliated Hospital of Guangxi Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-11-30

Contact for this trial

Li Jiang, MD

+86 15994349883 jiangli@sr.gxmu.edu.cn

View on ClinicalTrials.gov More Nasopharyngeal Carcinoma (NPC) trials