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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044020
Receipt No. R000050265
Scientific Title Research on the relationship between jaw closing force and swallowing function
Date of disclosure of the study information 2021/06/01
Last modified on 2021/04/23

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Basic information
Public title Research on the relationship between jaw closing force and swallowing function
Acronym Research on the relationship between jaw closing force and swallowing function
Scientific Title Research on the relationship between jaw closing force and swallowing function
Scientific Title:Acronym Research on the relationship between jaw closing force and swallowing function
Region
Japan

Condition
Condition dysphagia
Classification by specialty
Rehabilitation medicine Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will develop a jaw-closing dysfunction meter that can measure the force of contraction of the muscles of mastication when the mandible closes, even for toothless people and elderly people with missing molar occlusion. Furthermore, using a jaw-closing force meter, we will investigate the relationship between jaw-closing force and swallowing function, physical function, and nutritional status, and clarify the effect of oral function on the whole body.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measures jaw closing force, bite force quotient, tongue pressure, masticatory function, and dry mouth, and evaluates the relationship between jaw closing force and oral function.
Key secondary outcomes Measure or question the closing force, BMI (Body Mass Index), limb skeletal muscle mass, grip strength, FOIS (Functional Oral Intake Scale), MNA-SF (Mini Nutritional Assessment Short-Form). Assess the relationship between jaw closure and physical function and nutritional status.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria (A): Healthy people between the ages of 20 and 65 (about 100 people regardless of gender)
(B): Healthy elderly people aged 65 and over living in the community (about 100 people regardless of gender)
(C): Diseased elderly people aged 65 and over (about 100 people regardless of gender)
Key exclusion criteria Subjects who have impaired cognitive function and cannot follow instructions.
Subjects who have anatomical defects due to surgery in the maxillofacial region.
Subjects with progressive muscle disease that can affect systemic muscles and the perioral region.
Subjects with temporomandibular joint symptoms.
Subjects who use implantable medical devices such as pacemakers.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Haruka
Middle name
Last name Tohara
Organization Tokyo Medical and Dental University
Division name Department of Dysphagia Rehabilitation
Zip code 113-8549
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
TEL 03-5803-5559
Email harukatohara@hotmail.com

Public contact
Name of contact person
1st name Haruka
Middle name
Last name Tohara
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Dysphagia Rehabilitation
Zip code 113-8549
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
TEL 03-5803-5559
Homepage URL
Email harukatohara@hotmail.com

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Company Limited Muratasseisakusho
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization General Affairs Section,faculty of dentistry,Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
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 06 Month 01 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 01 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No special mention

Management information
Registered date
2021 Year 04 Month 23 Day
Last modified on
2021 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050265

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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