UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036300 |
|---|---|
| Receipt number | R000041360 |
| Scientific Title | Elucidating dental factors caused by the decline in nutrition and food diversity and preventing frail |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2024/03/29 10:18:05 |
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Basic information
Public title
Elucidating dental factors caused by the decline in nutrition and food diversity and preventing frail
Acronym
Elucidating dental factors caused by the decline in nutrition and food diversity and preventing frail
Scientific Title
Elucidating dental factors caused by the decline in nutrition and food diversity and preventing frail
Scientific Title:Acronym
Elucidating dental factors caused by the decline in nutrition and food diversity and preventing frail
Region
| Japan |
Condition
Condition
dentition with missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improve oral flail and increase nutrition and food diversity.
Stop the progress of flail at a reversible point, and contribute to the deterioration of health insurance finance and the resolution of the 2025 problem.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Food intake diversity assessment
Masticatory score
Nutritional status
Health condition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nutrition instruction, rehabilitation instruction every three months
Interventions/Control_2
Without the nutrition instruction, rehabilitation instruction every three months
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
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly people over the age of 65 who visit our hospital dental outpatient department.
Even if you have a history of high blood pressure, diabetes, heart disease, digestive system disease, respiratory disease etc., it will be targeted if it is possible for dental treatment as usual.
Key exclusion criteria
Person who can not obtain consent for research
A person who has difficulty in following the instructions of the operator due to diseases such as dementia
Person with cerebrovascular disorder, progressive neurological disease
A person with temporomandibular disorder
Patients who have any anatomical defect or dysfunction in the perioral tissue due to oral cancer, trauma, congenital malformation, etc.
With obvious dysphagia
Patients who have serious systemic diseases and are in a condition requiring constant management such as monitoring
Person who may affect general condition by sudden change of blood pressure by conduct of various examinations
In the middle of dental treatment
What has a bad denture
The remaining 20 teeth not complete and having no denture
Severe dentition irregularities
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kan |
| Middle name | |
| Last name | Nagao |
Organization
Tokushima University Graduate School of Oral Sciences
Division name
Department of Prosthodontics and Oral Rehabilitation
Zip code
7708504
Address
3-18-15 Kuramoto, Tokushima, Japan
TEL
088-633-7347
kan@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Fujimoto |
Organization
Tokushima University Graduate School of Oral Sciences
Division name
Department of Prosthodontics and Oral Rehabilitation
Zip code
7708504
Address
3-18-15 Kuramoto, Tokushima, Japan
TEL
088-633-7347
Homepage URL
fujimoto.keiko@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Graduate School of Oral Sciences, Department of Prosthodontics and Oral Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Clinical trial center for developmental therapeutics
Address
2-50-1 Kuramoto, Tokushima, Japan
Tel
088-633-9294
awachiken@tokushima-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
| 2019 | Year | 06 | Month | 01 | 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
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | 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
| 2019 | Year | 03 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041360
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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