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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034476
Receipt No. R000039307
Scientific Title Development of the health-promotion system by monitoring chewing behavior-Randamaized control trial for mastication modification-
Date of disclosure of the study information 2018/10/15
Last modified on 2019/04/16

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Basic information
Public title Development of the health-promotion system by monitoring chewing behavior-Randamaized control trial for mastication modification-
Acronym Development of the health-promotion system by monitoring chewing behavior
Scientific Title Development of the health-promotion system by monitoring chewing behavior-Randamaized control trial for mastication modification-
Scientific Title:Acronym Development of the health-promotion system by monitoring chewing behavior
Region
Japan

Condition
Condition Mastication disorder
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effict on masticatory modification of IoT device
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of the number of matication
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Instruction for mastication
Interventions/Control_2 Instruction for mastication and use matication counter
Interventions/Control_3 Instruction for mastication and use matication counter with algorithm
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. older than 20 and younger than 70
2. obtain agreement
Key exclusion criteria 1. dysphagia
2. TMD
3. under dental treatment
4. under medicated treatment for diabetes or hyperlipidemia
5. bitescan developer

Target sample size 240

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Ono
Organization Niigata University
Division name Graduate school of medical and dental sciences
Zip code 9518514
Address 2-5214 Gakkocho-dori Niigata city
TEL 0252272891
Email ono@dent.niigata-u.ac.jp

Public contact
Name of contact person
1st name Kazuhiro
Middle name
Last name Hori
Organization niigata university
Division name Graduate school of medical and dental sciences
Zip code 9518514
Address 2-5214 Gakkocho-dori Niigata city
TEL 0252272891
Homepage URL
Email hori@dent.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization AMED
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 IRB of Niigata University
Address 2-5214 Gakkochodori
Tel 0252272625
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
2018 Year 10 Month 15 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 No longer recruiting
Date of protocol fixation
2018 Year 10 Month 12 Day
Date of IRB
2018 Year 10 Month 12 Day
Anticipated trial start date
2018 Year 10 Month 17 Day
Last follow-up date
2019 Year 05 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
2018 Year 10 Month 13 Day
Last modified on
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039307

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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