UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030374 |
|---|---|
| Receipt number | 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 13:04:59 |
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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
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
ono@dent.niigata-u.ac.jp
Sponsor or person
Institute
Division of Comprehensive Prosthodontics
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034453
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
