UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060671 |
|---|---|
| Receipt number | R000069392 |
| Scientific Title | Evaluation of the Marginal Morphology of the Orbicularis Oris Muscle Using Ultrasonography and Its Relationship to Lip Closure Force |
| Date of disclosure of the study information | 2026/02/13 |
| Last modified on | 2026/02/13 19:03:37 |
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Basic information
Public title
Assessment of the Marginal Morphology of the Orbicularis Oris Muscle Using Ultrasonography and Investigation of Lip Closure Force
Acronym
US Evaluation of Orbicularis Oris Morphology and Lip Closure Force
Scientific Title
Evaluation of the Marginal Morphology of the Orbicularis Oris Muscle Using Ultrasonography and Its Relationship to Lip Closure Force
Scientific Title:Acronym
US of the Orbicularis Oris Morphology and Lip Closure Force Study
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lip closure force (maximum lip closure force measured in Newtons using a lip closure force measuring device; the highest value of three measurements will be used; assessed at the time of examination)
Key secondary outcomes
Marginal morphology classification and thickness of the orbicularis oris muscle assessed by ultrasonography
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 100 | 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 sample size
40
Research contact person
Name of lead principal investigator
| 1st name | mai |
| Middle name | |
| Last name | Okubo |
Organization
Tokyo Dental College
Division name
Department of Oral Health and Clinical Science, Division of Dysphagia Rehabilitation
Zip code
101-0061
Address
2-9-18 Misakicho, Tokyo, Chiyoda-ku, Japan
TEL
03-6380-9221
mokubo@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Okubo |
Organization
Tokyo Dental College,
Division name
Department of Oral Health and Clinical Science, Division of Dysphagia Rehabilitation,
Zip code
101-0061
Address
2-9-18 Misakicho, Tokyo, Chiyoda-ku, Japan
TEL
03-6380-9221
Homepage URL
mokubo@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Tokyo Dental College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Dental College
Address
2-9-18 Misakicho, Tokyo, Chiyoda-ku, 101-0061, Japan
Tel
03-6380-9221
mokubo@tdc.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
38
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study. Young adults (20-40 years) and older adults (>=65 years) will undergo ultrasonographic assessment of the marginal morphology and thickness of the orbicularis oris muscle. Lip closure force will be measured using a lip closure force measuring device, and the maximum value will be recorded. The marginal morphology will be classified into three types, and the association between morphology and lip closure force will be analyzed. Statistical analyses will include the Steel-Dwass multiple comparison test and the Mann-Whitney U test. No follow-up will be conducted, and all assessments will be performed at a single time point.
Management information
Registered date
| 2026 | Year | 02 | Month | 13 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069392
