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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028818
Receipt No. R000032986
Scientific Title Relationship between daily exercise and oral function
Date of disclosure of the study information 2017/08/25
Last modified on 2019/08/27

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Basic information
Public title Relationship between daily exercise and oral function
Acronym Daily exercise and oral function
Scientific Title Relationship between daily exercise and oral function
Scientific Title:Acronym Daily exercise and oral function
Region
Japan

Condition
Condition Missing teeth
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In present research, we reveal the relationship between daily exercise such as walking and oral function in older people, and reveal the effect of aging on the relationship by comparing with the result in young people.
Basic objectives2 Others
Basic objectives -Others To reveal the relationship between daily exercise and oral function, and the effect of aging on the relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral function (oral diadochokinesis, masticatory function by using gummy gerry, tongue pressure, lip closing pressure)
Key secondary outcomes Questionnaire about daily exercise, grip power, oral examination

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
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Evaluation of oral function, once
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Older people of societies in community who are over 65 years old, and dental students who are 20-30 years old.
Key exclusion criteria Those who are under orthodontic treatment and/or have food allergy.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Junichi
Middle name
Last name Furuya
Organization Tokyo Medical and Dental University
Division name Oral Health Sciences for Community Welfare
Zip code 1138549
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-4545
Email furuya.ohcw@tmd.ac.jp

Public contact
Name of contact person
1st name Furuya
Middle name
Last name Junichi
Organization Tokyo Medical and Dental University
Division name Oral Health Sciences for Community Welfare
Zip code 1138549
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-4545
Homepage URL
Email furuya.ohcw@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Faculty of Dentistry, Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel 03-3813-6111
Email furuya.ohcw@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
2017 Year 08 Month 25 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 25 Day
Date of IRB
2017 Year 08 Month 28 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2022 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
2017 Year 08 Month 25 Day
Last modified on
2019 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032986

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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