UMIN-CTR Clinical Trial

Basic information
Public title	Masticatory muscle activity and jaw movement in various exercises
Acronym	Masticatory muscle activity and jaw movement in various exercises
Scientific Title	Masticatory muscle activity and jaw movement in various exercises
Scientific Title:Acronym	Masticatory muscle activity and jaw movement in various exercises
Region	Japan

Condition
Condition	Healthy person, person with movement disorder
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In recent years, it has been found that people do not always bite during exercises. However, studies on the fixation and movement of the lower jaw during exercise are less clear. Therefore, in this study, we examine the masticatory muscle activity and jaw movement during various exercises for healthy person and persons with movement disorders. This study not only examines the masticatory muscle activity and jaw movement during various exercises, but also examines the effectiveness of the custom-made mouthguard on exercise capacity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle activity Evaluate changes in EMG during various exercises. Test muscle is temporal muscle, masseter muscle, digastric muscle. Evaluation is performed by calculating% MVC from each muscle's MVC
Key secondary outcomes	Jaw movement Evaluate changes in jaw movement during various exercises. In combination with the Video, evaluate the movement of the lower jaw for each exersise movement.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The subject wears a custom made mouth guard and exercises. The measurement is performed three times.
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Person without subjective or objective disorders of the stomatognathic system, cervicofacial area.
Key exclusion criteria	Person who can not communicate Person who can not perform various exercises properly Persons who may be injured during various exercises Persons who wearing denture
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Suzuki
Organization	Nihon University Nihon University School of Dentistry at Matsudo
Division name	Division of Oral Function and Rehabilitation, Department of Oral Health Science
Zip code	271-8587
Address	2-870-1 Sakaechonishi Matsudo City Chiba
TEL	047-360-9642
Email	suzuki.hiroshi@nihon-u.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Suzuki
Organization	Nihon University School of Dentistry at Matsudo
Division name	Division of Oral Function and Rehabilitation, Department of Oral Health Science
Zip code	271-8587
Address	2-870-1 Sakaechonishi Matsudo City Chiba
TEL	047-360-9642
Homepage URL
Email	suzuki.hiroshi@nihon-u.ac.jp

Sponsor
Institute	Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo
Institute
Department

Funding Source
Organization	Nihon University School of Dentistry at Matsudo
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	Nihon University School of Dentistry at Matsudo
Address	2-870-1 Sakaechonishi Matsudo City Chiba
Tel	047-360-9642
Email	yasudakihiro@gmail.com

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	2019 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	28
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	2016 Year 02 Month 15 Day
Date of IRB	2016 Year 06 Month 21 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2021 Year 07 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	2019 Year 06 Month 28 Day
Last modified on	2022 Year 07 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042406