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Impacted Tooth Management and Osteoradionecrosis Risk in NPC

10 de agosto de 2026 actualizado por: min kang, First Affiliated Hospital of Guangxi Medical University

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

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Prophylactic extraction of impacted teeth before radiotherapy is performed to reduce the potential risk of dental complications and jaw osteoradionecrosis after treatment. However, whether prophylactic extraction is necessary for impacted teeth without indications for therapeutic extraction remains uncertain.

This study is designed to evaluate whether omission of prophylactic impacted tooth extraction is noninferior to conventional prophylactic extraction with respect to the risk of jaw osteoradionecrosis in patients with non-metastatic nasopharyngeal carcinoma undergoing curative-intent radiotherapy. The study will also assess the long-term clinical outcomes and safety of this tooth-management strategy.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

536

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Zhen Meng, MD
  • Número de teléfono: +86 15578301825
  • Correo electrónico: mengzhen0307@163.com

Ubicaciones de estudio

  • Porcelana
    • Guangxi
      • Baise City, Guangxi, Porcelana, 533000
        • Affiliated Hospital of Youjiang Medical University for Nationalities
        • Contacto:
          • Tingzhuang Yi, MD
          • Número de teléfono: +86 776-2802090
          • Correo electrónico: ytz20070101@163.com
      • Beihai, Guangxi, Porcelana, 536000
        • Beihai People's Hospital
        • Contacto:
          • Sihui Liao, MD
          • Número de teléfono: +86 779 2023316
          • Correo electrónico: 13507799365@136.com
      • Guigang, Guangxi, Porcelana, 537100
        • Guigang People's Hospital
        • Contacto:
          • Yan Wei, MD
          • Número de teléfono: +86 15678865869
          • Correo electrónico: wyan184@163.com
      • Guilin, Guangxi, Porcelana, 541001
        • The Affiliated Hospital of Guilin Medical University
        • Contacto:
      • Liuzhou, Guangxi, Porcelana, 545006
        • Liuzhou People's Hospital
        • Contacto:
          • Jingchang Li, MD
          • Número de teléfono: +86 18078259868
          • Correo electrónico: 549026160@qq.com
      • Liuzhou, Guangxi, Porcelana, 545007
        • Liuzhou Workers' Hospital
        • Contacto:
          • Ying Lu, MD
          • Número de teléfono: +86 772 3815405
          • Correo electrónico: 1786734840@qq.com
      • Nanning, Guangxi, Porcelana, 530021
        • The First Affiliated Hospital of Guangxi Medical University
        • Contacto:
      • Nanning, Guangxi, Porcelana, 530000
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Contacto:
      • Nanning, Guangxi, Porcelana, 530199
        • Wuming Hospital Affiliated to Guangxi Medical University
        • Contacto:
          • Weiming Zhang, MS
          • Número de teléfono: +86 771-6363880
          • Correo electrónico: weiming8207@163.com
      • Wuzhou, Guangxi, Porcelana, 543002
        • Wuzhou Red Cross Hospital
        • Contacto:
      • Yulin, Guangxi, Porcelana, 537000
        • The First People's Hospital of Yulin
        • Contacto:
          • Leifeng Liang, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 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.
  • Uncontrolled psychiatric disorders or inability to provide legally valid informed consent.
  • Positive hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA >1,000 copies/mL.
  • Active hepatitis C virus infection (positive HCV RNA).
  • Human immunodeficiency virus (HIV) infection or diagnosis of acquired immunodeficiency syndrome (AIDS).
  • Active tuberculosis within the previous 1 year.
  • History of active tuberculosis more than 1 year previously without documented completion of standard anti-tuberculosis treatment.
  • Any other medical, psychological, social, or laboratory condition that, in the investigator's judgment, may compromise participant safety, interfere with study procedures, affect protocol compliance, or result in premature withdrawal from the study.
  • Refusal or inability to provide written informed consent.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Omission of Prophylactic Extraction Group
Participants assigned to this group will not undergo prophylactic extraction of impacted teeth before radiotherapy.
Otro: Omission of Prophylactic Impacted Tooth Extraction
Participants will not undergo prophylactic extraction of eligible impacted teeth before radiotherapy.
Comparador activo: Conventional Prophylactic Extraction Group
Participants assigned to this group will undergo conventional prophylactic extraction of impacted teeth before radiotherapy.
Procedimiento: Prophylactic Impacted Tooth Extraction
Participants will undergo prophylactic extraction of eligible impacted teeth before radiotherapy according to the study protocol.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
2-Year Cumulative Incidence of Jaw Osteoradionecrosis
Periodo de tiempo: Within 24 months after completion of radiotherapy
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
2-Year Overall Survival
Periodo de tiempo: 24 months after randomization
The 2-year overall survival rate will be estimated as the probability of remaining alive at 24 months after randomization and compared between the two treatment groups.
24 months after randomization
2-Year Event-Free Survival
Periodo de tiempo: 24 months after randomization
The 2-year event-free survival rate will be estimated as the probability of remaining free from local recurrence, regional recurrence, distant metastasis, or death from any cause at 24 months after randomization and compared between the two treatment groups.
24 months after randomization
2-Year Local Relapse-Free Survival
Periodo de tiempo: 24 months after randomization
The 2-year local relapse-free survival rate will be estimated as the probability of remaining free from local recurrence or death at 24 months after randomization and compared between the two treatment groups.
24 months after randomization
2-Year Regional Relapse-Free Survival
Periodo de tiempo: 24 months after randomization
The 2-year regional relapse-free survival rate will be estimated as the probability of remaining free from regional recurrence or death at 24 months after randomization and compared between the two treatment groups.
24 months after randomization
2-Year Distant Metastasis-Free Survival
Periodo de tiempo: 24 months after randomization
The 2-year distant metastasis-free survival rate will be estimated as the probability of remaining free from distant metastasis or death from any cause at 24 months after randomization and compared between the two treatment groups.
24 months after randomization
Quality of Life Assessed by the EORTC QLQ-C30
Periodo de tiempo: Baseline and 3, 6, 12, and 24 months after completion of radiotherapy
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores are transformed to a 0-100 scale. Higher scores on the functional scales and global health status/quality-of-life scale indicate better functioning or quality of life, whereas higher scores on the symptom scales indicate greater symptom burden.
Baseline and 3, 6, 12, and 24 months after completion of radiotherapy
Head and Neck Cancer-Specific Quality of Life Assessed by the EORTC QLQ-H&N35
Periodo de tiempo: Baseline and 3, 6, 12, and 24 months after completion of radiotherapy
Head and neck cancer-specific symptoms and quality-of-life problems will be assessed using the EORTC QLQ-H&N35 questionnaire. Scores are transformed to a 0-100 scale, with higher scores indicating greater symptom burden or more severe problems.
Baseline and 3, 6, 12, and 24 months after completion of radiotherapy
Acute Treatment-Related Toxicities
Periodo de tiempo: From initiation of treatment through 90 days after completion of radiotherapy
The incidence and severity of acute treatment-related toxicities will be assessed and compared between the two treatment groups. Toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, as applicable.
From initiation of treatment through 90 days after completion of radiotherapy
5-Year Cumulative Incidence of Jaw Osteoradionecrosis
Periodo de tiempo: Within 60 months after completion of radiotherapy
The cumulative incidence of jaw osteoradionecrosis (JORN) within 60 months after completion of radiotherapy will be estimated and compared between the two treatment groups.
Within 60 months after completion of radiotherapy
5-Year Overall Survival
Periodo de tiempo: 60 months after randomization
The 5-year overall survival rate will be estimated as the probability of remaining alive at 60 months after randomization and compared between the two treatment groups.
60 months after randomization
5-Year Event-Free Survival
Periodo de tiempo: 60 months after randomization
The 5-year event-free survival rate will be estimated as the probability of remaining free from local recurrence, regional recurrence, distant metastasis, or death from any cause at 60 months after randomization and compared between the two treatment groups.
60 months after randomization
5-Year Local Relapse-Free Survival
Periodo de tiempo: 60 months after randomization
The 5-year local relapse-free survival rate will be estimated as the probability of remaining free from local recurrence or death from any cause at 60 months after randomization and compared between the two treatment groups.
60 months after randomization
5-Year Regional Relapse-Free Survival
Periodo de tiempo: 60 months after randomization
The 5-year regional relapse-free survival rate will be estimated as the probability of remaining free from regional recurrence or death from any cause at 60 months after randomization and compared between the two treatment groups.
60 months after randomization
5-Year Distant Metastasis-Free Survival
Periodo de tiempo: 60 months after randomization
The 5-year distant metastasis-free survival rate will be estimated as the probability of remaining free from distant metastasis or death from any cause at 60 months after randomization and compared between the two treatment groups.
60 months after randomization
Late Treatment-Related Toxicities
Periodo de tiempo: From more than 90 days through 60 months after completion of radiotherapy
The incidence and severity of late treatment-related toxicities will be assessed and compared between the two treatment groups using the RTOG/EORTC late radiation morbidity scoring criteria and CTCAE version 5.0, as applicable.
From more than 90 days through 60 months after completion of radiotherapy

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

First Affiliated Hospital of Guangxi Medical University

Colaboradores

Wuzhou Red Cross Hospital
LiuZhou People's Hospital
First People's Hospital of Yulin
Guigang People's Hospital
Affiliated Hospital of Guilin University
People's Hospital of Guangxi Zhuang Autonomous Region
Youjiang Medical College for Nationalities
Liuzhou Workers' Hospital

Investigadores

  • Investigador principal: Min Kang, MD, First Affiliated Hospital of Guangxi Medical University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

30 de agosto de 2026

Finalización primaria (Estimado)

30 de noviembre de 2029

Finalización del estudio (Estimado)

30 de noviembre de 2032

Fechas de registro del estudio

Enviado por primera vez

26 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de agosto de 2026

Publicado por primera vez (Actual)

14 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • FirstGuangxiMU02

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data (IPD) will not be shared because the study data are subject to institutional, ethical, and participant confidentiality requirements.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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