UMIN-CTR Clinical Trial

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	2025 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 08 Month 25 Day
Last modified on	2022 Year 08 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032986