UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063550 |
|---|---|
| Receipt number | R000071744 |
| Scientific Title | Oral Function Training Program for the Prevention and Improvement of Oral Hypofunction |
| Date of disclosure of the study information | 2026/11/06 |
| Last modified on | 2026/11/06 18:12:10 |
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Basic information
Public title
Oral Function Training Program for the Prevention and Improvement of Oral Hypofunction
Acronym
Oral Function Training Program for the Prevention and Improvement of Oral Hypofunction
Scientific Title
Oral Function Training Program for the Prevention and Improvement of Oral Hypofunction
Scientific Title:Acronym
Oral Function Training Program for the Prevention and Improvement of Oral Hypofunction
Region
| Japan |
Condition
Condition
Oral hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a three-month oral function training program, including gum chewing, on oral function and oral frailty-related outcomes in individuals aged 50 years or older diagnosed with oral hypofunction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in oral functions related to oral hypofunction at 3 months after the start of the intervention, assessed by oral hygiene status, oral dryness, occlusal force, masticatory performance, oral diadochokinesis, tongue pressure, and swallowing function.
Key secondary outcomes
Changes from baseline to 3 months in oral frailty status, Kihon Checklist (KCL) score, Dietary Variety Score (DVS), and chewing gum-based masticatory assessment; adherence to the oral exercise program; and questionnaire-based outcomes.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants diagnosed with oral hypofunction will undergo a 3-month oral function training program. The training will be performed three times daily, for approximately 10 minutes per session, preferably after meals. The program will include oral exercises incorporating gum chewing, together with guidance on the importance of chewing ability and the habit of thorough mastication.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 50 years or older who are diagnosed with oral hypofunction at a dental clinic.
2. Individuals who are independent or require only mild support and are able to attend a dental clinic.
3. Individuals without dysphagia or severe dementia.
4. Individuals without allergy to the chewing gum used in the study.
5. Individuals with a score of 4 or higher on the 10-point chewing gum test, or those judged by a dentist to be able to chew the gum safely.
6. Individuals who are able to understand the purpose and procedures of the study and provide voluntary written informed consent.
Key exclusion criteria
Individuals who are judged by a dentist to be unsuitable for participation in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Irie |
Organization
Nagasaki University
Division name
Department of Oral Health, Medical and Dental Sciences, Graduate School of Biomedical Sciences
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki
TEL
095-819-7662
iriko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Irie |
Organization
Nagasaki University
Division name
Department of Oral Health, Medical and Dental Sciences, Graduate School of Biomedical Sciences
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki
TEL
095-819-7662
Homepage URL
iriko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Koichiro Irie
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Nagasaki University Graduate School of Biomedical Sciences
Address
1-12-4 Sakamoto, Nagasaki-shi, Nagasaki
Tel
095-819-7198
gakujutu_gakuji@ml.nagasaki-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
| 2026 | Year | 11 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 08 | 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
| 2026 | Year | 11 | Month | 06 | Day |
Last modified on
| 2026 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071744
