UMIN-CTR Clinical Trial

Basic information
Public title	Study on the amount and the property of the saliva in the time of oral relaxation
Acronym	The efficacy of oral relaxation method
Scientific Title	Study on the amount and the property of the saliva in the time of oral relaxation
Scientific Title:Acronym	The efficacy of oral relaxation method
Region	Japan

Condition
Condition	Healthy subjects, Stress, Xerostomia
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Relaxation of a stress at the time of oral relaxation is considered using saliva.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Before and after implementation of oral relaxation and consideration by various methods Decrease of stress hormone(CgA) in the saliva Increase of amount of saliva Increase of antioxidative potency in the saliva by BAPtest Expansion of the peripheral artery width
Key secondary outcomes	Comparison between the age Consideration of a presence of taking medicine and smoking.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	After a question investigation, 3 kinds of oral relaxation is performed as a hand skill. It takes 30 minutes in total, in for each 5 minutes.
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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) When agreeing, be less than 99 years old more than 20 years old. (2) The Person who feels a xerostomia (3) The person who feels a stress (4) Written informed Consent
Key exclusion criteria	(1) The person who can't extract saliva (2) The person who can't plan for communication (3) The person who has a bruise in the oral (4) The person who judged that the study person in charge was unsuitable about participation in this research
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Attsue Middle name Last name Matsumoto
Organization	Hiroshima University
Division name	Oral Health Sciences Major
Zip code	7340023
Address	1-2-3 Kasumi Minami-Ku Hiroshima-City
TEL	+81822575956
Email	atu@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Atsue Middle name Last name Matsumoto
Organization	Hiroshima University
Division name	Oral Health Sciences Major
Zip code	7340023
Address	1-2-3 Kasumi Minami-Ku Hiroshima-City
TEL	+81822575956
Homepage URL
Email	atu@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	None
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	Hiroshima University
Address	1-2-3 Kasumi Minami-Ku Hiroshima-City
Tel	082-257-1551
Email	kasumi-kenkyu@office.hiroshima-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	広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information	2018 Year 02 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	170
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2008 Year 12 Month 01 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 09 Month 15 Day
Date of IRB	2019 Year 09 Month 24 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2020 Year 12 Month 23 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 01 Month 18 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035243