Impacted Tooth Management and Osteoradionecrosis Risk in NPC

Summary

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.

Conditions

• Nasopharyngeal Carcinoma (NPC)
• Osteoradionecrosis of the Jaw

Interventions

OTHER

Omission of Prophylactic Impacted Tooth Extraction

Participants will not undergo prophylactic extraction of eligible impacted teeth before radiotherapy.

PROCEDURE

Prophylactic Impacted Tooth Extraction

Participants will undergo prophylactic extraction of eligible impacted teeth before radiotherapy according to the study protocol.

Sponsors & Collaborators

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• LiuZhou People's Hospital

  collaborator OTHER

• Liuzhou Workers' Hospital

  collaborator OTHER_GOV

• Wuzhou Red Cross Hospital

  collaborator OTHER

• Guigang People's Hospital

  collaborator OTHER

• First People's Hospital of Yulin

  collaborator OTHER

• Affiliated Hospital of Guilin University

  collaborator UNKNOWN

• Youjiang Medical College for Nationalities

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-30

Primary Completion

2029-11-30

Completion

2032-11-30

Countries

• China

Study Locations