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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047348


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name