UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017241 |
|---|---|
| Receipt number | R000020004 |
| Scientific Title | Does restriction of mandibular movements during sleep influence jaw-muscle activity? |
| Date of disclosure of the study information | 2015/04/22 |
| Last modified on | 2015/04/22 16:55:42 |
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Basic information
Public title
Does restriction of mandibular movements during sleep influence jaw-muscle activity?
Acronym
All shapes of splint inhibit sleep bruxism
Scientific Title
Does restriction of mandibular movements during sleep influence jaw-muscle activity?
Scientific Title:Acronym
All shapes of splint inhibit sleep bruxism
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of restriction of
mandibular movements during sleep on jaw-muscle electromyographic (EMG) activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Masticatory myographic activity during sleep
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing splint
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All subjects had self-reports of sleep bruxism during the last 6 months as indicated by sleep partner. The inclusion criteria were also a full dentition except third molars without any caries or periodontal problems.
Key exclusion criteria
Subjects who don't fulfil the inclusion criteria
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Arima |
Organization
Hokkaido Unviersity
Division name
Graduate School of Dental Medicine
Zip code
Address
North13 West7, Kita-ku, Sapporo
TEL
0117064275
tar@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Arima |
Organization
Hokkaido University
Division name
Graduate School of Dental Medicine
Zip code
Address
North13 West7, Kita-ku, Sapporo
TEL
0117064275
Homepage URL
tar@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
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
Address
Tel
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
| 2015 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2004 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 22 | Day |
Last modified on
| 2015 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020004
