UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032792 |
|---|---|
| Receipt number | R000037352 |
| Scientific Title | The short-term inhibiting effect of occlusal splint with contingent vibratory stimulus on sleep bruxism |
| Date of disclosure of the study information | 2018/06/04 |
| Last modified on | 2022/06/09 22:34:38 |
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Basic information
Public title
The short-term inhibiting effect of occlusal splint with contingent vibratory stimulus on sleep bruxism
Acronym
The short-term effect of contingent vibratory stimulus for sleep bruxism inhibition
Scientific Title
The short-term inhibiting effect of occlusal splint with contingent vibratory stimulus on sleep bruxism
Scientific Title:Acronym
The short-term effect of contingent vibratory stimulus for sleep bruxism inhibition
Region
| Japan |
Condition
Condition
Sleep bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the short-term effects of vibration stimulation on sleep bruxism and sleep quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Masseter muscle EMG during sleep
Key secondary outcomes
Total sleep time, EEG, sleep stage, micro arousal, subjective evaluation for deep sleep
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The subjects are monitored masseter muscle EMG overnight wearing the occlusal splint with vibratory stimulus generator after one night habituation of the splint. The vibratory stimulus is set to occur when the electric signal from the intra-splint force detector surpasses 15% of the maximum voluntary contraction level and is scheduled to be applied intermittently for 30 min, with 30 min-intervals.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Students or faculties who belong to the university or university dental hospital
Presence of occlusal contact with natural dentition
Those who gave written informed consent in first-person
Key exclusion criteria
Two or more missing molars, excluding third molars
Use of removable prosthesis
Use of medication with possible effects on sleep or motor behavior
Alcohol or drug abuse
Ongoing physical or dental therapy, including orthodontic treatment
Presence of major neurological or psychiatric disorders
Presence of Sleep disorder (e.g., sleep apnea syndrome, narcolepsy)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Takaba |
Organization
Showa University
Division name
Department of Prosthodontics
Zip code
145-8515
Address
2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
TEL
03-3787-1151
mtakaba@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Abe |
Organization
Showa University
Division name
Department of Prosthodontics
Zip code
152-0001
Address
2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
TEL
03-3787-1151
Homepage URL
abeyuka@dent.showa-u.ac.jp
Sponsor or person
Institute
Department of Prosthodontics, Showa University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Showa University
IRB Contact (For public release)
Organization
Ethics Committee of Showa University
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo, Japan
Tel
0337871151
funabata@ofc.showa-u.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
| 2018 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s11325-019-01782-x
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s11325-019-01782-x
Number of participants that the trial has enrolled
13
Results
The number of SB episodes tended to decrease with the vibration stimuli, and the decrease in the total SB duration was statistically significant (14.3 +- 9.5 vs. 26.0 +- 20.0, p = 0.03). No substantial change was found in terms of the micro-arousal index.
Results date posted
| 2022 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 01 | Month | 26 | Day |
Baseline Characteristics
Sleep bruxism
Participant flow
After making a clinical diagnosis based on clinical symptoms, sleep bruxism-related masticatory muscle activity was examined for a definitive diagnosis. Experiments were then performed.
Adverse events
None
Outcome measures
The number of SB episodes (times/hour)
The total SB duration (seconds/hour)
The mean duration of SB episodes (seconds/episode)
The micro-arousal index (times/hour)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 28 | 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 | 05 | Month | 30 | Day |
Last modified on
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037352
