UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057936 |
|---|---|
| Receipt number | R000066226 |
| Scientific Title | A Study on the Effect of Introducing an Oral Function Improvement Program for Older Adults Using Day-care Services |
| Date of disclosure of the study information | 2025/05/22 |
| Last modified on | 2025/11/22 10:31:08 |
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Basic information
Public title
Effect of an Oral Function Improvement Program for Older Adults Using Day-care Services
Acronym
OFIP-D Study (Oral Function Improvement Program for Day-care users)
Scientific Title
A Study on the Effect of Introducing an Oral Function Improvement Program for Older Adults Using Day-care Services
Scientific Title:Acronym
OFIP-D Study
Region
| Japan |
Condition
Condition
oral hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study targets older adults requiring long-term care who use day services (day-care and day rehabilitation services). An oral function improvement program will be introduced, and its effects on improving oral hypofunction and influencing overall physical function will be examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement rate of oral hypofunction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants will engage in a 30-minute oral function improvement program during their use of day services. The intervention will be conducted twice a week for eight weeks, totaling 16 sessions.
Interventions/Control_2
The control group will receive no intervention.
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
Participants will be selected based on the following inclusion criteria:
1. Individuals certified as requiring support level 1 or 2, or care level 1 or 2, who use day services at least twice a week
2. Men and women aged 65 years or older
3. Individuals diagnosed with oral hypofunction
4. Individuals who have provided written informed consent
Key exclusion criteria
Participants will be excluded from the study if any of the following criteria apply:
1. Individuals with disorders of the jaw or oral function, or those currently undergoing treatment for such conditions
2. Individuals diagnosed as requiring dental treatment that may affect oral function during the intervention period
3. Individuals diagnosed with dementia
4. Individuals who cannot undergo body composition measurement using bioelectrical impedance analysis due to the presence of a pacemaker, prosthetic limb(s), or similar devices
5. Individuals who do not consume food orally
6. Individuals who are unable to participate in the pre- and post-intervention assessments
7. Any other individuals deemed unsuitable for participation by the study dentist
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Mizutani |
Organization
Kyushu University
Division name
OBT Center, Faculty of Dental Science
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
0926426485
mizutani@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Mizutani |
Organization
Kyushu University
Division name
OBT Center, Faculty of Dental Science
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
0926426485
Homepage URL
mizutani@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
ExaWizards Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Office, Research Support Section, Department of Administrative Affairs, Kyushu University Hospital
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
Tel
092-642-5082
kyudai-rinri@jimu.kyushu-u.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
| 2025 | Year | 05 | Month | 22 | 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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 05 | Month | 22 | Day |
Last modified on
| 2025 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066226
