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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032933
Receipt No. R000037542
Scientific Title The effects of isometric exercise on maximum bite forces for elders
Date of disclosure of the study information 2018/08/01
Last modified on 2019/06/10

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Basic information
Public title The effects of isometric exercise on maximum bite forces for elders
Acronym isometric exercise of jaw muscle for elders
Scientific Title The effects of isometric exercise on maximum bite forces for elders
Scientific Title:Acronym isometric exercise of jaw muscle for elders
Region
Japan

Condition
Condition full or partial edentulous
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to determine whether the short term, isometric exercise of musticatory muscle with maximum occlusal power is also effective for elders like young adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes bite force
EMG
echo analysis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Each group was randomly divided
into an equal number of control and experimental subjects.
Experimental subjects are asked to
clench on the splint for 10 sec, five times a day for 4 weeks.
Interventions/Control_2 Controls are given an unrelated instruction like behavior.
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
65 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria full or partial edentulous elders who are older than 65
Key exclusion criteria The subjects selected were generally healthy, with no temporomandibular joint (TMJ) problem
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Haruka
Middle name
Last name Tohara
Organization TMDU
Division name Graduate School of Medical and Dental Sciences
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN
TEL 03-5803-5559
Email haruka-t@rd5.so-net.ne.jp

Public contact
Name of contact person
1st name Satoru
Middle name
Last name Takano
Organization TMDU
Division name Graduate School of Medical and Dental Sciences
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN
TEL 03-5803-5559
Homepage URL
Email s.takano.gerd@tmd.ac.jp

Sponsor
Institute TMDU
Institute
Department

Funding Source
Organization private
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization none
Address none
Tel none
Email none

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
2018 Year 08 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 Open public recruiting
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2018 Year 08 Month 27 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 08 Day
Last modified on
2019 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037542

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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