Impacted Tooth Management and Osteoradionecrosis Risk in NPC
Omission of Prophylactic Impacted Tooth Extraction and Risk of Jaw Osteoradionecrosis in Nasopharyngeal Carcinoma: A Multicenter, Noninferiority, Open-Label, Randomized Controlled Trial
1 other identifier
interventional
536
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2026
CompletedFirst Posted
Study publicly available on registry
August 14, 2026
CompletedStudy Start
First participant enrolled
August 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2029
Study Completion
Last participant's last visit for all outcomes
November 30, 2032
August 14, 2026
August 1, 2026
3.3 years
March 26, 2026
August 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2-Year Cumulative Incidence of Jaw Osteoradionecrosis
The cumulative incidence of jaw osteoradionecrosis (JORN) within 24 months after completion of radiotherapy will be estimated and compared between the two treatment groups.
Within 24 months after completion of radiotherapy
Secondary Outcomes (15)
2-Year Overall Survival
24 months after randomization
2-Year Event-Free Survival
24 months after randomization
2-Year Local Relapse-Free Survival
24 months after randomization
2-Year Regional Relapse-Free Survival
24 months after randomization
2-Year Distant Metastasis-Free Survival
24 months after randomization
- +10 more secondary outcomes
Study Arms (2)
Omission of Prophylactic Extraction Group
EXPERIMENTALParticipants assigned to this group will not undergo prophylactic extraction of impacted teeth before radiotherapy.
Conventional Prophylactic Extraction Group
ACTIVE COMPARATORParticipants assigned to this group will undergo conventional prophylactic extraction of impacted teeth before radiotherapy.
Interventions
Participants will not undergo prophylactic extraction of eligible impacted teeth before radiotherapy.
Participants will undergo prophylactic extraction of eligible impacted teeth before radiotherapy according to the study protocol.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 third molars with radiographic evidence of periapical or periodontal inflammation.
- Third molars completely impacted within the jawbone.
- History of active malignancy or other malignant tumors diagnosed within the previous 5 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ.
- Previous chemotherapy, surgery (except diagnostic procedures), radiotherapy, or other antitumor treatment for nasopharyngeal carcinoma or cervical lesions.
- Patients receiving palliative treatment.
- Pregnant or breastfeeding women.
- Severe uncontrolled cardiovascular or cerebrovascular diseases.
- Severe hepatic or renal dysfunction.
- Uncontrolled diabetes mellitus.
- Severe osteoporosis, medication-related osteonecrosis/osteomyelitis, or chronic diseases requiring long-term systemic corticosteroid therapy.
- Other severe chronic debilitating diseases that may increase study risk or affect study compliance.
- History of drug abuse or alcohol dependence.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- First Affiliated Hospital of Guangxi Medical Universitylead
- People's Hospital of Guangxi Zhuang Autonomous Regioncollaborator
- LiuZhou People's Hospitalcollaborator
- Liuzhou Workers' Hospitalcollaborator
- Wuzhou Red Cross Hospitalcollaborator
- Guigang People's Hospitalcollaborator
- First People's Hospital of Yulincollaborator
- Affiliated Hospital of Guilin Universitycollaborator
- Youjiang Medical College for Nationalitiescollaborator
Study Sites (11)
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise City, Guangxi, 533000, China
Beihai People's Hospital
Beihai, Guangxi, 536000, China
Guigang People's Hospital
Guigang, Guangxi, 537100, China
The Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001, China
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006, China
Liuzhou Workers' Hospital
Liuzhou, Guangxi, 545007, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530000, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Wuming Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530199, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, 543002, China
The First People's Hospital of Yulin
Yulin, Guangxi, 537000, China
Related Publications (5)
Kubota H, Miyawaki D, Mukumoto N, Ishihara T, Matsumura M, Hasegawa T, Akashi M, Kiyota N, Shinomiya H, Teshima M, Nibu KI, Sasaki R. Risk factors for osteoradionecrosis of the jaw in patients with head and neck squamous cell carcinoma. Radiat Oncol. 2021 Jan 5;16(1):1. doi: 10.1186/s13014-020-01701-5.
PMID: 33402192RESULTvan der Geer SJ, van Rijn PV, Kamstra JI, Langendijk JA, van der Laan BFAM, Roodenburg JLN, Dijkstra PU. Prevalence and prediction of trismus in patients with head and neck cancer: A cross-sectional study. Head Neck. 2019 Jan;41(1):64-71. doi: 10.1002/hed.25369. Epub 2018 Dec 18.
PMID: 30561067RESULTYang L, Hong S, Wang Y, Chen H, Liang S, Peng P, Chen Y. Development and External Validation of Nomograms for Predicting Survival in Nasopharyngeal Carcinoma Patients after Definitive Radiotherapy. Sci Rep. 2015 Oct 26;5:15638. doi: 10.1038/srep15638.
PMID: 26497224RESULTChen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6.
PMID: 31178151RESULTBray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PMID: 38572751RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min Kang, MD
First Affiliated Hospital of Guangxi Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Radiation Oncology Department, The First Affiliated Hospital of Guangxi Medical University
Study Record Dates
First Submitted
March 26, 2026
First Posted
August 14, 2026
Study Start (Estimated)
August 30, 2026
Primary Completion (Estimated)
November 30, 2029
Study Completion (Estimated)
November 30, 2032
Last Updated
August 14, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared because the study data are subject to institutional, ethical, and participant confidentiality requirements.