UMIN-CTR Clinical Trial

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
Email	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
Email	inoue.miho@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University, Institute of Biomedical Sciences, Graduate school
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047348