UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037204
Receipt number R000042406
Scientific Title Masticatory muscle activity and jaw movement in various exercises
Date of disclosure of the study information 2019/07/10
Last modified on 2022/07/01 12:12:16

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042406


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name