Tokyo, Feb. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060671) titled 'Assessment of the Marginal Morphology of the Orbicularis Oris Muscle Using Ultrasonography and Investigation of Lip Closure Force' on Feb. 13.
Study Type:
Observational
Primary Sponsor:
Institute - Tokyo Dental College
Condition:
Condition - Healthy older adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Lip closure force is involved in swallowing and speech articulation, and it may decrease with aging or systemic disease. Reduced lip closure force can contribute to food spillage and coughing during meals; therefore, maintaining and improving lip closure force in older adults is considered important. It has been reported that the marginal morphology of the orbicularis oris muscle observed on sagittal ultrasonographic imaging can be classified into three types (Hyun Jin P., 2020). We are currently conducting sagittal ultrasonographic imaging of the orbicularis oris muscle in cadavers and examining its correspondence with histological specimens.
The present study aims to investigate whether differences in the marginal morphology of the orbicularis oris muscle are associated with oral function. If a relationship between morphological differences and oral function is identified, the findings may contribute to the development of morphology-specific rehabilitation strategies.
In this study, lip closure force will be used as the parameter of oral function. The objective is to examine the relationship between the marginal morphology of the orbicularis oris muscle and lip closure force.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 25
years-old
=
Gender - Male and Female
Key inclusion criteria - Individuals who provide written informed consent (for nursing home residents, consent obtained from the participant or a legally authorized representative)
Young adult group: males and females aged 20 to 40 years (university staff or students)
Older adult group: males and females aged 65 years or older (residents of a special nursing home for the elderly)
Able to comply with the examination procedures and undergo measurements in a seated position
Key exclusion criteria - History or presence of malignancy, trauma, neurological disease, or dermatologic disorders in the maxillofacial/oral region
History of lip surgery or cosmetic treatment of the lips
Previous experience with lip closure training
Target Size - 40
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2022 Year 07 Month 25 Day
Date of IRB - 2022 Year 07 Month 25 Day
Anticipated trial start date - 2023 Year 01 Month 29 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069392
Disclaimer: Curated by HT Syndication.