이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Impacted Tooth Management and Osteoradionecrosis Risk in NPC

2026년 8월 10일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

536

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 중국
    • Guangxi
      • Baise City, Guangxi, 중국, 533000
        • Affiliated Hospital of Youjiang Medical University for Nationalities
        • 연락하다:
      • Beihai, Guangxi, 중국, 536000
        • Beihai People's Hospital
        • 연락하다:
      • Guigang, Guangxi, 중국, 537100
        • Guigang People's Hospital
        • 연락하다:
      • Guilin, Guangxi, 중국, 541001
        • The Affiliated Hospital of Guilin Medical University
        • 연락하다:
      • Liuzhou, Guangxi, 중국, 545006
        • Liuzhou People's Hospital
        • 연락하다:
      • Liuzhou, Guangxi, 중국, 545007
        • Liuzhou Workers' Hospital
        • 연락하다:
      • Nanning, Guangxi, 중국, 530021
        • The First Affiliated Hospital of Guangxi Medical University
        • 연락하다:
      • Nanning, Guangxi, 중국, 530000
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • 연락하다:
      • Nanning, Guangxi, 중국, 530199
        • Wuming Hospital Affiliated to Guangxi Medical University
        • 연락하다:
      • Wuzhou, Guangxi, 중국, 543002
        • Wuzhou Red Cross Hospital
        • 연락하다:
      • Yulin, Guangxi, 중국, 537000
        • The First People's Hospital of Yulin
        • 연락하다:
          • Leifeng Liang, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Omission of Prophylactic Extraction Group
Participants assigned to this group will not undergo prophylactic extraction of impacted teeth before radiotherapy.
다른: Omission of Prophylactic Impacted Tooth Extraction
Participants will not undergo prophylactic extraction of eligible impacted teeth before radiotherapy.
활성 비교기: Conventional Prophylactic Extraction Group
Participants assigned to this group will undergo conventional prophylactic extraction of impacted teeth before radiotherapy.
절차: Prophylactic Impacted Tooth Extraction
Participants will undergo prophylactic extraction of eligible impacted teeth before radiotherapy according to the study protocol.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
2-Year Cumulative Incidence of Jaw Osteoradionecrosis
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
2-Year Overall Survival
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

First Affiliated Hospital of Guangxi Medical University

협력자

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

수사관

  • 수석 연구원: Min Kang, MD, First Affiliated Hospital of Guangxi Medical University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 30일

기본 완료 (추정된)

2029년 11월 30일

연구 완료 (추정된)

2032년 11월 30일

연구 등록 날짜

최초 제출

2026년 3월 26일

QC 기준을 충족하는 최초 제출

2026년 8월 10일

처음 게시됨 (실제)

2026년 8월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 10일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • FirstGuangxiMU02

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다