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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032162
Receipt No. R000036400
Scientific Title Study on the effect of habit training on awake clenching activity
Date of disclosure of the study information 2018/05/16
Last modified on 2018/04/09

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Basic information
Public title Study on the effect of habit training on awake clenching activity
Acronym Habit Training to suppress awake clenching
Scientific Title Study on the effect of habit training on awake clenching activity
Scientific Title:Acronym Habit Training to suppress awake clenching
Region
Japan

Condition
Condition awake bruxism
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the difference between habit reversal training and tongue tip positioning training on the activity of awake bruxism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cumulative duration of clenching higher than 20%MVC at 14th day point and 10 weeks point
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
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 habit reversal treatment
Interventions/Control_2 Training for tongue tip position
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
90 years-old >
Gender Male and Female
Key inclusion criteria Subject who shows the duration of clenching activity of >=20%MVC for longer than 2.07 minutes.
Key exclusion criteria 1) subject who has any uncomfortable reaction to the dressing tape
2) subject who cannot follow the instructions
Target sample size 70

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
TEL 086-235-6685
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
TEL 086-235-6685
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 Other
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
2018 Year 05 Month 16 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 16 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
2018 Year 04 Month 09 Day
Last modified on
2018 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036400

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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