Clinical trial NCT06941727: Relationship Between Mouth Opening and Masseter Elasticity in Oral Cancer
Official title: Association Between Maximum Mouth Opening and Masseter Muscle Elasticity in Oral Cancer Patients: A Study Using Sonographic Elastography
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Oral Cancer
Keywords: Maximum interincisal opening
Elastography
Masseter muscle
Elasticity
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Masseter muscle elasticity
timeFrame: Pre-intervention, 8 weeks post-intervention
measure: Maximum interincisal mouth opening
timeFrame: Pre-intervention, 8 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University, College of Medicine
name: Yueh-Hsia Chen
role: PRINCIPAL_INVESTIGATOR
References:
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