UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032933 |
|---|---|
| Receipt number | 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 | 2020/12/29 21:28:26 |
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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
52
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
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
s.takano.gerd@tmd.ac.jp
Sponsor or person
Institute
TMDU
Institute
Department
Personal name
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
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 | 08 | 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
| 2020 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037542
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
