UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041533 |
|---|---|
| Receipt number | R000047348 |
| Scientific Title | Effect of aromatherapy for sleep bruxism |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2021/08/30 12:28:09 |
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Basic information
Public title
Effect of aromatherapy for sleep bruxism
Acronym
Effect of aromatherapy for sleep bruxism
Scientific Title
Effect of aromatherapy for sleep bruxism
Scientific Title:Acronym
Effect of aromatherapy for sleep bruxism
Region
| Japan |
Condition
Condition
sleep bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To concern the effect of aromatherapy for sleep bruxism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
measuring for 10 days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
using wearable electromyograph for 10 days, to include 4 days with aroma oil, 6 days as control.
measurement using 4 kinds of aroma oil.
Interventions/Control_2
aroma oil, lavender
Interventions/Control_3
aroma oil, bergamot
Interventions/Control_4
aroma oil, marjoram
Interventions/Control_5
aroma oil, rosewood
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy people for student of Tokushima University of dental school and Graduate school, staff of dental school.
Key exclusion criteria
The person who does not hope for the participation.
A person having a psychophysiological disease
The person who does not cooperate with mention of questionnaire about the sleep
The person who does not expect the measurement by the wearable electromyograph
Pregnant woman
The person with the underlying disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Inoue |
Organization
Tokushima University, Institute of Biomedical Sciences, Graduate school
Division name
Department of stomatognathic function and occlusal reconstrucion
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima city
TEL
088-633-7350
inoue.miho@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Inoue |
Organization
Tokushima University, Institute of Biomedical Sciences, Graduate school
Division name
Department of stomatognathic function and occlusal reconstrucion
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima city
TEL
0886337350
Homepage URL
inoue.miho@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University, Institute of Biomedical Sciences, Graduate school
Institute
Department
Personal name
Funding Source
Organization
Tokushima University, Institute of Biomedical Sciences, Graduate school
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University, Institute of Biomedical Sciences, Graduate school
Address
3-18-15 Kuramoto-cho, Tokushima city
Tel
0886337350
inoue.miho@tokushima-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
| 2020 | Year | 11 | 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
| 2020 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 24 | Day |
Last modified on
| 2021 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047348
