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Impacted Tooth Management and Osteoradionecrosis Risk in NPC

10 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

536

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Omission of Prophylactic Extraction Group
Participants assigned to this group will not undergo prophylactic extraction of impacted teeth before radiotherapy.
Altro: Omission of Prophylactic Impacted Tooth Extraction
Participants will not undergo prophylactic extraction of eligible impacted teeth before radiotherapy.
Comparatore attivo: Conventional Prophylactic Extraction Group
Participants assigned to this group will undergo conventional prophylactic extraction of impacted teeth before radiotherapy.
Procedura: Prophylactic Impacted Tooth Extraction
Participants will undergo prophylactic extraction of eligible impacted teeth before radiotherapy according to the study protocol.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
2-Year Cumulative Incidence of Jaw Osteoradionecrosis
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
2-Year Overall Survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

First Affiliated Hospital of Guangxi Medical University

Collaboratori

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

Investigatori

  • Investigatore principale: Min Kang, MD, First Affiliated Hospital of Guangxi Medical University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 agosto 2026

Completamento primario (Stimato)

30 novembre 2029

Completamento dello studio (Stimato)

30 novembre 2032

Date di iscrizione allo studio

Primo inviato

26 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 agosto 2026

Primo Inserito (Effettivo)

14 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FirstGuangxiMU02

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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