UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030870 |
|---|---|
| Receipt number | R000035243 |
| Scientific Title | Study on the amount and the property of the saliva in the time of oral relaxation |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2021/01/05 09:52:53 |
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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
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
atu@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035243
