UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040375
Receipt number R000044378
Scientific Title The effect of oral appliances for masticatory muscle activity during the sleep.
Date of disclosure of the study information 2020/05/13
Last modified on 2020/11/11 12:32:23

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Basic information

Public title

The effect of oral appliances for masticatory muscle activity during the sleep.

Acronym

The effect of oral appliances for masticatory muscle activity during the sleep.

Scientific Title

The effect of oral appliances for masticatory muscle activity during the sleep.

Scientific Title:Acronym

The effect of oral appliances for masticatory muscle activity during the sleep.

Region

Japan


Condition

Condition

teeth grinding

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the masticatory muscles activity by the difference of material (hardware materials, soft materials, hybrid materials) of the oral appliances during sleep.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the effect of oral appliances for masticatory muscle activity during the sleep.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Hard oral apliance for 3days

Interventions/Control_2

Soft oral apliance for 3days

Interventions/Control_3

hibrid oral apliance for 3days

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

The person that there is not doubt of temporomandibular disorder by a questionnaire.

Key exclusion criteria

The person suspected of having temporomandibular disorder excludes it by a questionnaire.

Target sample size

100


Research contact person

Name of lead principal investigator

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

870-1 Sakaecho, Nishi-2, Matsudo, Chiba

TEL

047-360-9642

Email

suzuki.hirshi91@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

870-1 Sakaecho, Nishi-2, Matsudo, Chiba

TEL

047-360-9642

Homepage URL


Email

suzuki.hirshi91@nihon-u.ac.jp


Sponsor or person

Institute

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

870-1 Sakaecho, Nishi-2, Matsudo, Chiba

Tel

047-360-9642

Email

suzuki.hiroshi91@nihon-u.ac.jp


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

2020 Year 05 Month 13 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2020 Year 04 Month 02 Day

Date of IRB

2020 Year 02 Month 09 Day

Anticipated trial start date

2020 Year 06 Month 01 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry

2021 Year 06 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 05 Month 12 Day

Last modified on

2020 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044378


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name