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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044164
Receipt No. 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

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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
Institute Tokyo Medical and Dental University
Institute
Department

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
URL(English) https://upload.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


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