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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036300
Receipt No. 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 2019/03/26

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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
Email 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
Email fujimoto.keiko@tokushima-u.ac.jp

Sponsor
Institute Tokushima University Graduate School of Oral Sciences, Department of Prosthodontics and Oral Rehabilitation
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2024 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
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041360

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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