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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026429
Receipt No. R000028560
Scientific Title Improvement trial of mastication method
Date of disclosure of the study information 2017/10/01
Last modified on 2018/03/09

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Basic information
Public title Improvement trial of mastication method
Acronym Improvement trial of mastication method
Scientific Title Improvement trial of mastication method
Scientific Title:Acronym Improvement trial of mastication method
Region
Japan

Condition
Condition normal participants
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This research aims to evaluate the practical advantage of bilateral mastication method compared to the mastication counting 30 strokes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes practical advantage evaluated by questionnaire
Key secondary outcomes subjective evaluations on taste and vexatious complications

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 counted unilateral mastication
Interventions/Control_2 bilateral mastication
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Number of functional teeth are 14 or more for upper dental arch and 14 or more for lower dental arch
Key exclusion criteria Taking medication which could affect the motor function or sensation of stomatognathic system.
History of TMD.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shogo Minagi
Organization Okayama University
Division name Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525
TEL 0862356687
Email minagi@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shogo Minagi
Organization Okayama University
Division name Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525
TEL 0862356687
Homepage URL
Email minagi@md.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 10 Month 01 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 Terminated
Date of protocol fixation
2017 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 06 Day
Last modified on
2018 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028560

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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