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NCT Number: NCT06941727

Relationship Between Mouth Opening and Masseter Elasticity in Oral Cancer

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University

Taipei, Taiwan

Location status: Recruiting

Location contact

Yueh-Hsia Chen, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Could not communicate.
  • Had any disorder that could influence movement performance.

Treatment and study plan

ultrasonographic imaging

Diagnostic Test

masseter muscle elasticity

Primary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yueh-Hsia Chen, PhD

CONTACT

[email protected]

+886-2-33668133

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Association Between Maximum Mouth Opening and Masseter Muscle Elasticity in Oral Cancer Patients: A Study Using Sonographic Elastography

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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