Oral CancerNCT06941727
Relationship Between Mouth Opening and Masseter Elasticity in Oral Cancer
An observational study of Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The study aims to assess the hardness of masticatory muscles in post-surgical oral cancer patients using strain elastography ultrasound, calculating the masseter elasticity index and exploring its association with maximum interincisal mouth opening. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Oral Cancer
- What is being tested?
- ultrasonographic imaging
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 May 2025to 31 Dec 2026
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 10 patients, aged 20 to 65 years, are first diagnosed with oral cancer and underwent surgery and routine physical therapy within three months.
Who may be able to join
- Newly diagnosed oral cancer patients who are scheduled to receive cancer-related treatments (e.g., oral cancer surgery, radiotherapy, chemotherapy, or chemoradiotherapy).
- Age between 20 and 65 years.
Who cannot join
- Could not communicate.
- Had any disorder that could influence movement performance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University
Taipei
Yueh-Hsia Chen, PhD
About this study
Official title: Association Between Maximum Mouth Opening and Masseter Muscle Elasticity in Oral Cancer Patients: A Study Using Sonographic Elastography
The study aims to assess the hardness of masticatory muscles in post-surgical oral cancer patients using strain elastography ultrasound, calculating the masseter elasticity index and exploring its association with maximum interincisal mouth opening. Furthermore, the study incorporates exercise training to analyze whether changes in masseter hardness can serve as an objective indicator for predicting the improvement of trismus.
Read the detailed description
This study aims to evaluate the hardness of masticatory muscles in patients who have undergone surgery for oral cancer, using strain elastography ultrasound. Specifically, the research focuses on measuring the elasticity of the masseter muscle by calculating the masseter elasticity index (MEI) and analyzing its correlation with maximum interincisal mouth opening (MIO). Since trismus, or restricted mouth opening, is a common post-surgical complication affecting oral function and quality of life, understanding the relationship between muscle elasticity and jaw mobility is crucial. Additionally, the study incorporates a structured exercise training program designed to improve jaw function in these patients. By monitoring changes in masseter muscle hardness before and after the intervention, the research aims to determine whether variations in muscle elasticity can serve as an objective indicator for predicting improvements in trismus.
- Conditions
- Oral Cancer
- Being tested
- ultrasonographic imaging
- Keywords
- Maximum interincisal opening, Elastography, Masseter muscle, Elasticity
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic imagingDiagnostic test
masseter muscle elasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Masseter muscle elasticity
The masseter elasticity index is calculated as the ratio of the average elasticity of the masseter muscle to that of the isolation-coupling Pad (icPad).
Measured: Pre-intervention, 8 weeks post-intervention
Maximum interincisal mouth opening
Maximum interincisal mouth opening is measured using a mouth-opening ruler, placed at the edges of the upper and lower central incisors to determine the distance.
Measured: Pre-intervention, 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start16 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yueh-Hsia Chen, PhD, Principal investigator, National Taiwan University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941727
- Sponsor's protocol ID
- 202502031RIN
- Status last verified
- Jan 2026
- First submitted
- 15 Apr 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yeh SA, Tang Y, Lui CC, Huang YJ, Huang EY. Treatment outcomes and late complications of 849 patients with nasopharyngeal carcinoma treated with radiotherapy alone. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):672-9. doi: 10.1016/j.ijrobp.2004.11.002.
PubMed 15936544Taljanovic MS, Gimber LH, Becker GW, Latt LD, Klauser AS, Melville DM, Gao L, Witte RS. Shear-Wave Elastography: Basic Physics and Musculoskeletal Applications. Radiographics. 2017 May-Jun;37(3):855-870. doi: 10.1148/rg.2017160116.
PubMed 28493799Takashima M, Arai Y, Kawamura A, Hayashi T, Takagi R. Quantitative evaluation of masseter muscle stiffness in patients with temporomandibular disorders using shear wave elastography. J Prosthodont Res. 2017 Oct;61(4):432-438. doi: 10.1016/j.jpor.2017.01.003. Epub 2017 Feb 7.
PubMed 28188109Karlsson O, Karlsson T, Pauli N, Andrell P, Finizia C. Jaw exercise therapy for the treatment of trismus in head and neck Cancer: a prospective three-year follow-up study. Support Care Cancer. 2021 Jul;29(7):3793-3800. doi: 10.1007/s00520-020-05517-7. Epub 2020 Nov 24.
PubMed 32435968Itoh A, Ueno E, Tohno E, Kamma H, Takahashi H, Shiina T, Yamakawa M, Matsumura T. Breast disease: clinical application of US elastography for diagnosis. Radiology. 2006 May;239(2):341-50. doi: 10.1148/radiol.2391041676. Epub 2006 Feb 16.
PubMed 16484352Chen YH, Liang WA, Hsu CY, Guo SL, Lien SH, Tseng HJ, Chao YH. Functional outcomes and quality of life after a 6-month early intervention program for oral cancer survivors: a single-arm clinical trial. PeerJ. 2018 Feb 21;6:e4419. doi: 10.7717/peerj.4419. eCollection 2018.
PubMed 29492348Cardoso RC, Kamal M, Zaveri J, Chambers MS, Gunn GB, Fuller CD, Lai SY, Mott FE, McMillan H, Hutcheson KA. Self-Reported Trismus: prevalence, severity and impact on quality of life in oropharyngeal cancer survivorship: a cross-sectional survey report from a comprehensive cancer center. Support Care Cancer. 2021 Apr;29(4):1825-1835. doi: 10.1007/s00520-020-05630-7. Epub 2020 Aug 11.
PubMed 32779007Ariji Y, Nakayama M, Nishiyama W, Nozawa M, Ariji E. Shear-wave sonoelastography for assessing masseter muscle hardness in comparison with strain sonoelastography: study with phantoms and healthy volunteers. Dentomaxillofac Radiol. 2016;45(2):20150251. doi: 10.1259/dmfr.20150251. Epub 2015 Dec 1.
PubMed 26624000
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Maximum Mouth Opening and Masseter Muscle Elasticity in Oral Cancer Patients: A Study Using Sonographic Elastography
- ClinicalTrials.gov ID
- NCT06941727
- Acronym / sponsor ID
- 202502031RIN
- Conditions
- Oral Cancer
- Keywords
- Maximum interincisal opening, Elastography, Masseter muscle, Elasticity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Apr 2025 (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.
The study aims to assess the hardness of masticatory muscles in post-surgical oral cancer patients using strain elastography ultrasound, calculating the masseter elasticity index and exploring its association with maximum interincisal mouth opening. Furthermore, the study incorporates exercise training to analyze whether changes in masseter hardness can serve as an objective indicator for predicting the improvement of trismus.
Detailed description
This study aims to evaluate the hardness of masticatory muscles in patients who have undergone surgery for oral cancer, using strain elastography ultrasound. Specifically, the research focuses on measuring the elasticity of the masseter muscle by calculating the masseter elasticity index (MEI) and analyzing its correlation with maximum interincisal mouth opening (MIO). Since trismus, or restricted mouth opening, is a common post-surgical complication affecting oral function and quality of life, understanding the relationship between muscle elasticity and jaw mobility is crucial. Additionally, the study incorporates a structured exercise training program designed to improve jaw function in these patients. By monitoring changes in masseter muscle hardness before and after the intervention, the research aims to determine whether variations in muscle elasticity can serve as an objective indicator for predicting improvements in trismus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 10 patients, aged 20 to 65 years, are first diagnosed with oral cancer and underwent surgery and routine physical therapy within three months.
Key inclusion criteria (2 listed)
- Newly diagnosed oral cancer patients who are scheduled to receive cancer-related treatments (e.g., oral cancer surgery, radiotherapy, chemotherapy, or chemoradiotherapy).
- Age between 20 and 65 years.
Key exclusion criteria (2 listed)
- Could not communicate.
- Had any disorder that could influence movement performance.
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 |
|---|---|---|
| ultrasonographic imagingmasseter muscle elasticity | Diagnostic test | – |
Primary outcome
Masseter muscle elasticity
Time frame: Pre-intervention, 8 weeks post-intervention
The masseter elasticity index is calculated as the ratio of the average elasticity of the masseter muscle to that of the isolation-coupling Pad (icPad).
Maximum interincisal mouth opening
Time frame: Pre-intervention, 8 weeks post-intervention
Maximum interincisal mouth opening is measured using a mouth-opening ruler, placed at the edges of the upper and lower central incisors to determine the distance.
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 18 May 2026.
- Background: PubMed 15936544Yeh SA, Tang Y, Lui CC, Huang YJ, Huang EY. Treatment outcomes and late complications of 849 patients with nasopharyngeal carcinoma treated with radiotherapy alone. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):672-9. doi: 10.1016/j.ijrobp.2004.11.002.
- Background: PubMed 28493799Taljanovic MS, Gimber LH, Becker GW, Latt LD, Klauser AS, Melville DM, Gao L, Witte RS. Shear-Wave Elastography: Basic Physics and Musculoskeletal Applications. Radiographics. 2017 May-Jun;37(3):855-870. doi: 10.1148/rg.2017160116.
- Background: PubMed 28188109Takashima M, Arai Y, Kawamura A, Hayashi T, Takagi R. Quantitative evaluation of masseter muscle stiffness in patients with temporomandibular disorders using shear wave elastography. J Prosthodont Res. 2017 Oct;61(4):432-438. doi: 10.1016/j.jpor.2017.01.003. Epub 2017 Feb 7.
- Background: PubMed 32435968Karlsson O, Karlsson T, Pauli N, Andrell P, Finizia C. Jaw exercise therapy for the treatment of trismus in head and neck Cancer: a prospective three-year follow-up study. Support Care Cancer. 2021 Jul;29(7):3793-3800. doi: 10.1007/s00520-020-05517-7. Epub 2020 Nov 24.
- Background: PubMed 16484352Itoh A, Ueno E, Tohno E, Kamma H, Takahashi H, Shiina T, Yamakawa M, Matsumura T. Breast disease: clinical application of US elastography for diagnosis. Radiology. 2006 May;239(2):341-50. doi: 10.1148/radiol.2391041676. Epub 2006 Feb 16.
- Background: PubMed 29492348Chen YH, Liang WA, Hsu CY, Guo SL, Lien SH, Tseng HJ, Chao YH. Functional outcomes and quality of life after a 6-month early intervention program for oral cancer survivors: a single-arm clinical trial. PeerJ. 2018 Feb 21;6:e4419. doi: 10.7717/peerj.4419. eCollection 2018.
- Background: PubMed 32779007Cardoso RC, Kamal M, Zaveri J, Chambers MS, Gunn GB, Fuller CD, Lai SY, Mott FE, McMillan H, Hutcheson KA. Self-Reported Trismus: prevalence, severity and impact on quality of life in oropharyngeal cancer survivorship: a cross-sectional survey report from a comprehensive cancer center. Support Care Cancer. 2021 Apr;29(4):1825-1835. doi: 10.1007/s00520-020-05630-7. Epub 2020 Aug 11.
- Background: PubMed 26624000Ariji Y, Nakayama M, Nishiyama W, Nozawa M, Ariji E. Shear-wave sonoelastography for assessing masseter muscle hardness in comparison with strain sonoelastography: study with phantoms and healthy volunteers. Dentomaxillofac Radiol. 2016;45(2):20150251. doi: 10.1259/dmfr.20150251. Epub 2015 Dec 1.
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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.
Yueh-Hsia Chen, PhD principal investigator
National Taiwan University, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 Yueh-Hsia Chen, PhD (+886-2-33668133, yuehhsiachen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masseter muscle elasticity (time frame: Pre-intervention, 8 weeks post-intervention). The study lists 2 primary outcomes in all. 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 NCT06941727, which also lists 8 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 18 May 2026.