UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Improvement trial of mastication method
Title of the study (Brief title)	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	Shogo Minagi
Organization	Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
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	Shogo Minagi
Organization	Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 01 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028560