Impacted Tooth Management and Osteoradionecrosis Risk in NPC

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Guangxi Medical University

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Omission of Prophylactic Impacted Tooth Extraction
  • Prophylactic Impacted Tooth Extraction

Treatment groups

536 Participants
are divided into 2 treatment groups

Sponsors and collaborators

First Affiliated Hospital of Guangxi Medical University

Lead sponsor

People's Hospital of Guangxi Zhuang Autonomous Region

Collaborator

LiuZhou People's Hospital

Collaborator

Liuzhou Workers' Hospital

Collaborator

Wuzhou Red Cross Hospital

Collaborator

Guigang People's Hospital

Collaborator

First People's Hospital of Yulin

Collaborator

Affiliated Hospital of Guilin University

Collaborator

Youjiang Medical College for Nationalities

Collaborator