Clinical trial · Observational
Relationship Between Mouth Opening and Masseter Elasticity in Oral Cancer
Association Between Maximum Mouth Opening and Masseter Muscle Elasticity in Oral Cancer Patients: A Study Using Sonographic Elastography
NCT06941727CI-TRIAL-00111873recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ultrasonographic imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Masseter muscle elasticity
- timeFrame
- Pre-intervention, 8 weeks post-intervention
- description
- 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).
- measure
- Maximum interincisal mouth opening
- timeFrame
- Pre-intervention, 8 weeks post-intervention
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed oral cancer patients who are scheduled to receive cancer-related treatments (e.g., oral cancer surgery, radiotherapy, chemotherapy, or chemoradiotherapy). 2. Age between 20 and 65 years. Exclusion Criteria: 1. Could not communicate. 2. Had any disorder that could influence movement performance.
References
Publications (8)
- BACKGROUNDYeh 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. PMID 15936544
- BACKGROUNDTaljanovic 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. PMID 28493799
- BACKGROUNDTakashima 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. PMID 28188109
- BACKGROUNDKarlsson 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. PMID 32435968
- BACKGROUNDItoh 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. PMID 16484352
- BACKGROUNDChen 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. PMID 29492348
- BACKGROUNDCardoso 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.