UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017240 |
|---|---|
| Receipt number | R000019999 |
| Scientific Title | Choice of biomaterials-Do soft occlusal splints influence jaw-muscle activity during sleep? |
| Date of disclosure of the study information | 2015/04/22 |
| Last modified on | 2015/04/22 16:37:26 |
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Basic information
Public title
Choice of biomaterials-Do soft occlusal splints influence jaw-muscle activity
during sleep?
Acronym
No influence of soft-material occlusal splint on sleep bruxism
Scientific Title
Choice of biomaterials-Do soft occlusal splints influence jaw-muscle activity
during sleep?
Scientific Title:Acronym
No influence of soft-material occlusal splint on sleep bruxism
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim was to investigate the effect
of another type of occlusal surface, such as a soft-material occlusal splint in addition to a hard-type OS in terms of
changes in jaw-muscle activity during sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of masseter electromyographic activity during sleep
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Different matrial of occlusal splints
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 were generally healthy,
more than 20 years old, and had full dentition (28 teeth).
Key exclusion criteria
current illness;
history of neurologic or psychiatric disorders; sleep disorders
(e.g. sleep apnea and periodic limb movement); use of prescription
medicine or drugs; smoking, alcohol abuse and addiction
to coffee; electrode gel allergy; simultaneous participation in
another trial with medicine or in trials of medical devices; and
user of pace maker.
Target sample size
15
Research contact person
Name of lead principal investigator
| 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
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
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | 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=R000019999
