UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044020 |
|---|---|
| Receipt number | 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 | 2022/10/26 20:59:49 |
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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
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
harukatohara@hotmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
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
| 2022 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050265
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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