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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Omission of Prophylactic Impacted Tooth Extraction
Other interventionParticipants will not undergo prophylactic extraction of eligible impacted teeth before radiotherapy.
Prophylactic Impacted Tooth Extraction
Procedure/SurgeryParticipants will undergo prophylactic extraction of eligible impacted teeth before radiotherapy according to the study protocol.
Treatment groups
536 Participants
are divided into 2 treatment groupsGroup A: Omission of Prophylactic Extraction GroupExperimental treatment 1 intervention
Group B: Conventional Prophylactic Extraction GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
2-Year Cumulative Incidence of Jaw Osteoradionecrosis
The cumulative incidence of jaw osteoradionecrosis (JORN) within 24 months after completion of radiotherapy will be estimated and compared between the two treatment groups.
Time frame
Within 24 months after completion of radiotherapySecondary outcomes
1
2-Year Overall Survival
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.
Time frame
24 months after randomization2
2-Year Event-Free Survival
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.
Time frame
24 months after randomization3
2-Year Local Relapse-Free Survival
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.
Time frame
24 months after randomization4
2-Year Regional Relapse-Free Survival
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.
Time frame
24 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov
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