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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06941727
Enrollment
10
Registered
2025-04-24
Start date
2025-05-16
Completion date
2026-12-31
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cancer

Keywords

Maximum interincisal opening, Elastography, Masseter muscle, Elasticity

Brief 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. 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.

Interventions

masseter muscle elasticity

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Masseter muscle elasticityPre-intervention, 8 weeks post-interventionThe 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 openingPre-intervention, 8 weeks post-interventionMaximum 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.

Countries

Taiwan

Contacts

CONTACTYueh-Hsia Chen, PhD
yuehhsiachen@ntu.edu.tw+886-2-33668133
PRINCIPAL_INVESTIGATORYueh-Hsia Chen, PhD

National Taiwan University, College of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026