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Impacted Tooth Management and Osteoradionecrosis Risk in NPC

10. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

536

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Omission of Prophylactic Extraction Group
Participants assigned to this group will not undergo prophylactic extraction of impacted teeth before radiotherapy.
Sonstiges: Omission of Prophylactic Impacted Tooth Extraction
Participants will not undergo prophylactic extraction of eligible impacted teeth before radiotherapy.
Aktiver Komparator: Conventional Prophylactic Extraction Group
Participants assigned to this group will undergo conventional prophylactic extraction of impacted teeth before radiotherapy.
Verfahren: Prophylactic Impacted Tooth Extraction
Participants will undergo prophylactic extraction of eligible impacted teeth before radiotherapy according to the study protocol.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
2-Year Cumulative Incidence of Jaw Osteoradionecrosis
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
2-Year Overall Survival
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

First Affiliated Hospital of Guangxi Medical University

Mitarbeiter

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

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. August 2026

Primärer Abschluss (Geschätzt)

30. November 2029

Studienabschluss (Geschätzt)

30. November 2032

Studienanmeldedaten

Zuerst eingereicht

26. März 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. August 2026

Zuerst gepostet (Tatsächlich)

14. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • FirstGuangxiMU02

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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