UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056427 |
|---|---|
| Receipt number | R000062052 |
| Scientific Title | Evaluation of Oral Hypofunction by Facial Expression and Development of Improvement Program in Older Adults: A Cross-Over Study |
| Date of disclosure of the study information | 2024/12/12 |
| Last modified on | 2025/07/04 15:41:54 |
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Basic information
Public title
Evaluation of Oral Hypofunction by Facial Expression and Development of Improvement Program in Older Adults
Acronym
Evaluation of Oral Hypofunction by Facial Expression and Development of Improvement Program
Scientific Title
Evaluation of Oral Hypofunction by Facial Expression and Development of Improvement Program in Older Adults: A Cross-Over Study
Scientific Title:Acronym
Evaluation of Oral Hypofunction by Facial Expression and Development of Improvement Program
Region
| Japan |
Condition
Condition
Oral Hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess oral hypofunction with facial expressions and evaluate the effectiveness of a program to improve oral hypofunction through an intervention study in older adults aged 65 years or older.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lip-Closing Force
Key secondary outcomes
- The Yamamoto methods for evaluating the performance of complete dentures
- EAT-10 (Japanese ver.)
- Kihon Checklist
- Facial Expression
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
8-week oral training program
Interventions/Control_2
No treatment
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Older adults who have provided written consent to participate in this study
Key exclusion criteria
Individuals with a history of cerebral infarction, facial paralysis, facial trauma, or other conditions that affect facial expression
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Taishi |
| Middle name | |
| Last name | Tsuji |
Organization
University of Tsukuba
Division name
Institute of Health and Sports Sciences
Zip code
112-0012
Address
3-29-1, Otsuka, Bunkyo-ku, Tokyo, Japan
TEL
03-3942-6459
tsuji.taishi.gn@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | |
| Last name | Tsuji |
Organization
University of Tsukuba
Division name
Institute of Health and Sports Sciences
Zip code
112-0012
Address
3-29-1, Otsuka, Bunkyo-ku, Tokyo, Japan
TEL
03-3942-6459
Homepage URL
tsuji.taishi.gn@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japanese Council of Senior Citizens Welfare Service
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Institute of Health and Sports Sciences, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
029-853-2571
tg-kenkyurinri@un.tsukuba.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
| 2024 | Year | 12 | Month | 12 | 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
76
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 11 | Day |
Last modified on
| 2025 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062052
