Nasopharyngeal Carcinoma (NPC)NCT07764887
Impacted Tooth Management and Osteoradionecrosis Risk in NPC
A study testing Omission of Prophylactic Impacted Tooth Extraction and Prophylactic Impacted Tooth Extraction in people with Nasopharyngeal Carcinoma (NPC) and Osteoradionecrosis of the Jaw, run by First Affiliated Hospital of Guangxi Medical University at 11 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC), Osteoradionecrosis of the Jaw
- What is being tested?
- Omission of Prophylactic Impacted Tooth Extraction and Prophylactic Impacted Tooth Extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 11 sitesChina
- Study dates
- 30 Aug 2026to 30 Nov 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise City, Guangxi, 533000
Tingzhuang Yi, MD, +86 776-2802090, ytz20070101@163.com
Beihai People's Hospital
Beihai, Guangxi, 536000
Sihui Liao, MD, +86 779 2023316, 13507799365@136.com
Guigang People's Hospital
Guigang, Guangxi, 537100
Yan Wei, MD, +86 15678865869, wyan184@163.com
The Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001
Xin Zhang, MD, +86 773 2833086, zhangxin1262008@126.com
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Jingchang Li, MD, +86 18078259868, 549026160@qq.com
Liuzhou Workers' Hospital
Liuzhou, Guangxi, 545007
Ying Lu, MD, +86 772 3815405, 1786734840@qq.com
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530000
Heming Lu, MD, +860771-5722416, luhming3632@163.com
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Li Jiang, MD, +86 15994349883, jiangli@sr.gxmu.edu.cn
Wuming Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530199
Weiming Zhang, MS, +86 771-6363880, weiming8207@163.com
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, 543002
Jianquan Gao, MD, +86 774 3827268, wzhh13878480321@163.com
The First People's Hospital of Yulin
Yulin, Guangxi, 537000
Leifeng Liang, MD
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Omission of Prophylactic Impacted Tooth Extraction, Prophylactic Impacted Tooth Extraction
- Keywords
- Nasopharyngeal carcinoma, Jaw osteoradionecrosis, Impacted tooth, Prophylactic tooth extraction, Intensity-modulated radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omission of Prophylactic Impacted Tooth ExtractionOther
Participants will not undergo prophylactic extraction of eligible impacted teeth before radiotherapy.
Prophylactic Impacted Tooth ExtractionProcedure or surgery
Participants will undergo prophylactic extraction of eligible impacted teeth before radiotherapy according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Omission of Prophylactic Extraction Group | Experimental | Participants assigned to this group will not undergo prophylactic extraction of impacted teeth before radiotherapy. Receives: Other: Omission of Prophylactic Impacted Tooth Extraction |
| Conventional Prophylactic Extraction Group | Active comparator | Participants assigned to this group will undergo conventional prophylactic extraction of impacted teeth before radiotherapy. Receives: Procedure: Prophylactic Impacted Tooth Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 months after completion of radiotherapy
Secondary outcomes (15)
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.
Measured: 24 months after randomization
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.
Measured: 24 months after randomization
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.
Measured: 24 months after randomization
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.
Measured: 24 months after randomization
2-Year Distant Metastasis-Free Survival
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.
Measured: 24 months after randomization
Quality of Life Assessed by the EORTC QLQ-C30
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.
Measured: 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
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.
Measured: Baseline and 3, 6, 12, and 24 months after completion of radiotherapy
Acute Treatment-Related Toxicities
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.
Measured: From initiation of treatment through 90 days after completion of radiotherapy
5-Year Cumulative Incidence of Jaw Osteoradionecrosis
The cumulative incidence of jaw osteoradionecrosis (JORN) within 60 months after completion of radiotherapy will be estimated and compared between the two treatment groups.
Measured: Within 60 months after completion of radiotherapy
5-Year Overall Survival
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.
Measured: 60 months after randomization
5-Year Event-Free Survival
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.
Measured: 60 months after randomization
5-Year Local Relapse-Free Survival
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.
Measured: 60 months after randomization
5-Year Regional Relapse-Free Survival
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.
Measured: 60 months after randomization
5-Year Distant Metastasis-Free Survival
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.
Measured: 60 months after randomization
Late Treatment-Related Toxicities
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.
Measured: From more than 90 days through 60 months after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region, LiuZhou People's Hospital, Liuzhou Workers' Hospital, Wuzhou Red Cross Hospital, Guigang People's Hospital, First People's Hospital of Yulin, Affiliated Hospital of Guilin University, Youjiang Medical College for Nationalities
- Responsible party
- Principal investigator, min kang, First Affiliated Hospital of Guangxi Medical University
- Investigators
- Min Kang, MD, Principal investigator, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764887
- Sponsor's protocol ID
- FirstGuangxiMU02
- Status last verified
- Aug 2026
- First submitted
- 26 Mar 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study data are subject to institutional, ethical, and participant confidentiality requirements.
Publications
Kubota H, Miyawaki D, Mukumoto N, Ishihara T, Matsumura M, Hasegawa T, Akashi M, Kiyota N, Shinomiya H, Teshima M, Nibu KI, Sasaki R. Risk factors for osteoradionecrosis of the jaw in patients with head and neck squamous cell carcinoma. Radiat Oncol. 2021 Jan 5;16(1):1. doi: 10.1186/s13014-020-01701-5.
PubMed 33402192van der Geer SJ, van Rijn PV, Kamstra JI, Langendijk JA, van der Laan BFAM, Roodenburg JLN, Dijkstra PU. Prevalence and prediction of trismus in patients with head and neck cancer: A cross-sectional study. Head Neck. 2019 Jan;41(1):64-71. doi: 10.1002/hed.25369. Epub 2018 Dec 18.
PubMed 30561067Yang L, Hong S, Wang Y, Chen H, Liang S, Peng P, Chen Y. Development and External Validation of Nomograms for Predicting Survival in Nasopharyngeal Carcinoma Patients after Definitive Radiotherapy. Sci Rep. 2015 Oct 26;5:15638. doi: 10.1038/srep15638.
PubMed 26497224Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6.
PubMed 31178151Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omission of Prophylactic Impacted Tooth Extraction and Risk of Jaw Osteoradionecrosis in Nasopharyngeal Carcinoma: A Multicenter, Noninferiority, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07764887
- Acronym / sponsor ID
- FirstGuangxiMU02
- Keywords
- Nasopharyngeal carcinoma, Jaw osteoradionecrosis, Impacted tooth, Prophylactic tooth extraction, Intensity-modulated radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region, LiuZhou People's Hospital, Liuzhou Workers' Hospital, Wuzhou Red Cross Hospital, Guigang People's Hospital, First People's Hospital of Yulin, Affiliated Hospital of Guilin University, Youjiang Medical College for Nationalities
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2032 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omission of Prophylactic Extraction Group | Experimental | Other: Omission of Prophylactic Impacted Tooth ExtractionParticipants assigned to this group will not undergo prophylactic extraction of impacted teeth before radiotherapy. |
| Conventional Prophylactic Extraction Group | Active comparator | Procedure: Prophylactic Impacted Tooth ExtractionParticipants assigned to this group will undergo conventional prophylactic extraction of impacted teeth before radiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omission of Prophylactic Impacted Tooth ExtractionParticipants will not undergo prophylactic extraction of eligible impacted teeth before radiotherapy. | Other | Omission of Prophylactic Extraction Group |
| Prophylactic Impacted Tooth ExtractionParticipants will undergo prophylactic extraction of eligible impacted teeth before radiotherapy according to the study protocol. | Procedure or surgery | Conventional Prophylactic Extraction Group |
Primary outcome
2-Year Cumulative Incidence of Jaw Osteoradionecrosis
Time frame: 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.
15 secondary outcomes
2-Year Overall Survival
Time frame: 24 months after randomization
2-Year Event-Free Survival
Time frame: 24 months after randomization
2-Year Local Relapse-Free Survival
Time frame: 24 months after randomization
2-Year Regional Relapse-Free Survival
Time frame: 24 months after randomization
2-Year Distant Metastasis-Free Survival
Time frame: 24 months after randomization
Quality of Life Assessed by the EORTC QLQ-C30
Time frame: 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
Time frame: Baseline and 3, 6, 12, and 24 months after completion of radiotherapy
Acute Treatment-Related Toxicities
Time frame: From initiation of treatment through 90 days after completion of radiotherapy
5-Year Cumulative Incidence of Jaw Osteoradionecrosis
Time frame: Within 60 months after completion of radiotherapy
5-Year Overall Survival
Time frame: 60 months after randomization
5-Year Event-Free Survival
Time frame: 60 months after randomization
5-Year Local Relapse-Free Survival
Time frame: 60 months after randomization
5-Year Regional Relapse-Free Survival
Time frame: 60 months after randomization
5-Year Distant Metastasis-Free Survival
Time frame: 60 months after randomization
Late Treatment-Related Toxicities
Time frame: From more than 90 days through 60 months after completion of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Results publication: PubMed 33402192Kubota H, Miyawaki D, Mukumoto N, Ishihara T, Matsumura M, Hasegawa T, Akashi M, Kiyota N, Shinomiya H, Teshima M, Nibu KI, Sasaki R. Risk factors for osteoradionecrosis of the jaw in patients with head and neck squamous cell carcinoma. Radiat Oncol. 2021 Jan 5;16(1):1. doi: 10.1186/s13014-020-01701-5.
- Results publication: PubMed 30561067van der Geer SJ, van Rijn PV, Kamstra JI, Langendijk JA, van der Laan BFAM, Roodenburg JLN, Dijkstra PU. Prevalence and prediction of trismus in patients with head and neck cancer: A cross-sectional study. Head Neck. 2019 Jan;41(1):64-71. doi: 10.1002/hed.25369. Epub 2018 Dec 18.
- Results publication: PubMed 26497224Yang L, Hong S, Wang Y, Chen H, Liang S, Peng P, Chen Y. Development and External Validation of Nomograms for Predicting Survival in Nasopharyngeal Carcinoma Patients after Definitive Radiotherapy. Sci Rep. 2015 Oct 26;5:15638. doi: 10.1038/srep15638.
- Results publication: PubMed 31178151Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6.
- Results publication: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study data are subject to institutional, ethical, and participant confidentiality requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Kang, MD principal investigator
First Affiliated Hospital of Guangxi Medical University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omission of Prophylactic Impacted Tooth Extraction and Prophylactic Impacted Tooth Extraction in people with Nasopharyngeal Carcinoma (NPC) and Osteoradionecrosis of the Jaw, run by First Affiliated Hospital of Guangxi Medical University at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Jiang, MD (+86 15994349883, jiangli@sr.gxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Year Cumulative Incidence of Jaw Osteoradionecrosis (time frame: Within 24 months after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07764887, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.