UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062619 |
|---|---|
| Receipt number | R000071682 |
| Scientific Title | Effects of an Oral Health Program for Community-Dwelling Older Adults on Oral and Physical Function |
| Date of disclosure of the study information | 2026/08/20 |
| Last modified on | 2026/08/19 17:58:09 |
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Basic information
Public title
Effects of an Oral Health Program for Community-Dwelling Older Adults on Oral and Physical Function
Acronym
Effects of an Oral Health Program for Community-Dwelling Older Adults on Oral and Physical Function
Scientific Title
Effects of an Oral Health Program for Community-Dwelling Older Adults on Oral and Physical Function
Scientific Title:Acronym
Effects of an Oral Health Program for Community-Dwelling Older Adults on Oral and Physical Function
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of an Oral Health Program for Community-Dwelling Older Adults on Oral and Physical Function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
masticatory ability
Key secondary outcomes
Oral Health, Physical Health, Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Oral Health Program (Oral Exercises Program + Oral Health Awareness Course)
Interventions/Control_2
Oral Exercises Program
Interventions/Control_3
No treatment
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
(1) Individuals who are able to travel to the facility on their own
(2) Individuals who are able to participate in the oral exercise program (including chewing gum)
(3) Individuals who are able to undergo physical function assessments, such as walking and standing on one foot with eyes open
(4) Individuals who have received a thorough explanation of the purpose and content of the study, possess the capacity to give informed consent, have fully understood the study,
have voluntarily agreed to participate, and have provided written consent to participate in this study
Key exclusion criteria
(1) Individuals who may experience an allergic reaction in connection with the trial
(2) Individuals whom the investigator has determined are not suitable for participation in this trial
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Okabayashi |
Organization
Lotte Co., Ltd.
Division name
Research and Development Center, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
okabayashi_kazuto@lotte.co.jp
Public contact
Name of contact person
| 1st name | Youko |
| Middle name | |
| Last name | Itou |
Organization
Lotte Co., Ltd.
Division name
Research and Development Center
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
itou_youko@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sakado Tsurugashima Dental Association
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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 | 08 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 08 | Month | 19 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071682
