UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043909 |
|---|---|
| Receipt number | R000050142 |
| Scientific Title | Investigation of effects of oral health program on oral and general health |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2023/10/15 13:11:11 |
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Basic information
Public title
Investigation of effects of oral health program on oral and general health
Acronym
Investigation of effects of oral health program on oral and general health
Scientific Title
Investigation of effects of oral health program on oral and general health
Scientific Title:Acronym
Investigation of effects of oral health program on oral and general health
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of oral health program on oral health literacy, nutritional status, and physical function in community dwelling older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral function (tongue pressure, lip tongue motor function, masticatory function)
Self reported oral health status before and 24 weeks after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Comprehensive program
1. Oral exercise
2. Eating munchy texture lunch once a month
3. Receiving lectures about oral health and nutrition once per two-month for each
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who can participate for 24 weeks
Key exclusion criteria
1. individuals who have food allergy
2. individuals who have severe renal failure
3. individuals who have severe dysphagia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsuo |
Organization
Tokyo Medical and Dental University
Division name
Oral Health Sciences for Community Welfare
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo, Tokyo,
TEL
03-5803-4545
matsuo.ohcw@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsuo |
Organization
Tokyo Medical and Dental University
Division name
Oral Health Sciences for Community Welfare
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo, Tokyo,
TEL
03-5803-4545
Homepage URL
matsuo.ohcw@tmd.ac.jp
Sponsor or person
Institute
Japan Science and Technology Agency
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo, Tokyo
Tel
03-3813-6111
d-hyoka.adm@tmd.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
| 2021 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12603-023-1913-1
Number of participants that the trial has enrolled
271
Results
Frail score and CAMCAM checklist scores were significantly lower in the Oral Frail (OF) group at the initial assessment. OF score and Frail score findings were significantly improved in the OF group after completing the program (all P <0.05). Regarding the CAMCAM checklist, awareness of chewing improved significantly in the Robust group (P=0.009), with a similar tendency in the OF group (P=0.080).
Results date posted
| 2023 | Year | 10 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 04 | Month | 28 | Day |
Baseline Characteristics
A total of 271 community-dwelling adults in 4 Japanese municipalities
Participant flow
A total of 271 community-dwelling adults in 4 Japanese municipalities were recruited, of which 249 participants (92%) were assessed at the final evaluation. Participants gathered once a month at community centers to learn about oral health and nutrition while eating a munchy textured lunch containing proper nutrition.
Adverse events
none
Outcome measures
Oral frailty, frailty, and eating behavior were evaluated with the Oral Frailty Index-8 (OFI-8), Kihon checklist (KCL), and CAMCAM checklist, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050142
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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