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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030374
Receipt No. R000034453
Scientific Title Development of the health-promotion system by monitoring chewing behavior: preliminary investigation for Japanese adults
Date of disclosure of the study information 2017/12/13
Last modified on 2020/06/16

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Basic information
Public title Development of the health-promotion system by monitoring chewing behavior: preliminary investigation for Japanese adults
Acronym Development of the health-promotion system by monitoring chewing behavior
Scientific Title Development of the health-promotion system by monitoring chewing behavior: preliminary investigation for Japanese adults
Scientific Title:Acronym Development of the health-promotion system by monitoring chewing behavior
Region
Japan

Condition
Condition disability of mastication
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Monitor chewing activity using the developed device, grasp mastication in healthy adults, and examine related factors
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mastication frequency, chewing speed, take-in frequency, chewing frequency per unit, meal time
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 monitor chewing exercise of 3 meals at a day and between meals with developed device and record
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adults over 20 years old agreed to participate in research
Key exclusion criteria persons have a severe eating / dysphagia disorder and even diagnosed that ingestion is impossible
persons have subjective / objectively abnormalities in the mandibular joint / mandibular oral cavity function
persons under dentistry or orthodontic treatment
Persons undergoing medication due to diabetes or hyperlipidemia
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Ono
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Comprehensive Prosthodontics
Zip code 9518514
Address 5274, Gakkocho-dori 2-bancho, Chuo-ku, Niigata
TEL +81-25-227-2891
Email ono@dent.niigata-u.ac.jp

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Ono
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Comprehensive Prosthodontics
Zip code 9518514
Address 5274, Gakkocho-dori 2-bancho, Chuo-ku, Niigata
TEL +81-25-227-2891
Homepage URL
Email ono@dent.niigata-u.ac.jp

Sponsor
Institute Division of Comprehensive Prosthodontics
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 Niigata University
Address 757 Ichibancho, Asahimachi-dori, Chuo Ward, Niigata City
Tel 025-227-2625
Email ethics@adm.niigata-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
2017 Year 12 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2017 Year 11 Month 20 Day
Date of IRB
2017 Year 11 Month 28 Day
Anticipated trial start date
2017 Year 11 Month 30 Day
Last follow-up date
2018 Year 01 Month 30 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 12 Month 13 Day
Last modified on
2020 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034453

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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