UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044164
Receipt number R000050105
Scientific Title Changes of pressure pain threshold and muscle stiffness in masticatory muscles by continuous clenching
Date of disclosure of the study information 2021/05/10
Last modified on 2021/05/10 19:29:14

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Basic information

Public title

Changes of pressure pain threshold and muscle stiffness in masticatory muscles by continuous clenching

Acronym

Changes of pressure pain threshold and muscle stiffness in masticatory muscles by continuous clenching

Scientific Title

Changes of pressure pain threshold and muscle stiffness in masticatory muscles by continuous clenching

Scientific Title:Acronym

Changes of pressure pain threshold and muscle stiffness in masticatory muscles by continuous clenching

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to compare the change of pressure pain threshold and muscle stiffness of masticatory muscle by two kinds of continuous clenching.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

・Pressure pain thresholds od masseter muscle and temporal muscle
・Tone and elasticity of masseter muscle and temporal muscle

Key secondary outcomes

・Intensity of spontaneous pain in masseter muscle and temporal muscle (Visual Analog Scale)
・Fatigue level of masseter muscle and temporal muscle (Visual Analog Scale)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Behavior,custom

Interventions/Control_1

Clenching Task A: The masseter muscle activity at the time of maximum bite is defined as 100% MVC. 15 seconds of clenching (50% MVC) for 30 times (There is a 15-second rest between each clench.)

Clenching Task B: The masseter muscle activity at the time of maximum bite is defined as 100% MVC. 75 seconds of clenching (10% MVC) for 30 times (There is a 15-second rest between each clench.)

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy adults

Key exclusion criteria

・Pain in the orofacial region within the past 3 months
・Palpation of masseter muscle and temporalis muscle (1kg, 2 seconds) causes pain
・Less than 24 teeth remaining
・Wearing removable denture
・Malocclusion (open bite of premolars and molars, opposing bite, crossbite)
・Psychiatric disorders
・Regular use of drugs that affect pain (NSAIDs, anti-anxiety drugs, etc.)
・Alcohol allergy

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Nishiyama

Organization

Tokyo Medical and Dental University

Division name

Dental Anesthesiology and Orofacial Pain Management

Zip code

113-8549

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5961

Email

anishi.tmj@tmd.ac.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name Nishiyama

Organization

Tokyo Medical and Dental University

Division name

Dental Anesthesiology and Orofacial Pain Management

Zip code

113-8549

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5961

Homepage URL


Email

anishi.tmj@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental 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

Ethics review committee, Dental school, Tokyo Medical and Dental University

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

Tel

03-5803-5404

Email

d-hyoka.adm@tmd.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

2021 Year 05 Month 10 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

2021 Year 05 Month 10 Day

Date of IRB


Anticipated trial start date

2021 Year 08 Month 01 Day

Last follow-up date

2023 Year 03 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

2021 Year 05 Month 10 Day

Last modified on

2021 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050105


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name