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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038122
Receipt No. R000043441
Scientific Title Stress assessment by dental treatment
Date of disclosure of the study information 2019/09/28
Last modified on 2021/03/27

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Basic information
Public title Stress assessment by dental treatment
Acronym Stress assessment by dental treatment
Scientific Title Stress assessment by dental treatment
Scientific Title:Acronym Stress assessment by dental treatment
Region
Japan

Condition
Condition Dental phobia
gag reflex
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analyze stress markers(amylase,cortisol,chromogranin A,IgA,etc.)from saliva to understand stress and examine non-invasive stress reduction methods.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amylase monitor
Visual analogue scale
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Saliva measurement
Interventions/Control_2 VAS
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1 dental phobia
2 severe gag reflex
3 White coat hypertension
4 Vascular vagus nerve reflex
Key exclusion criteria 1 Mental disorders
2 Dementia
Target sample size 150

Research contact person
Name of lead principal investigator
1st name YUKIHIKO
Middle name
Last name TAKEMURA
Organization Graduate School of Dentistry Kanagawa Dental University
Division name Department of Oral Interdisciplinary Medicine
Zip code 238-8580
Address 82 Inaoka-cho, Yokosuka, Kanagawa
TEL 046-822-8854
Email takemura@kdu.ac.jp

Public contact
Name of contact person
1st name YUKIHIKO
Middle name
Last name TAKEMURA
Organization Graduate School of Dentistry Kanagawa Dental University
Division name Department of Oral Interdisciplinary Medicine
Zip code 238-8580
Address 82 Inaoka-cho, Yokosuka, Kanagawa
TEL 046-822-8854
Homepage URL
Email takemura@kdu.ac.jp

Sponsor
Institute Kanagawa Dental University
Institute
Department

Funding Source
Organization Kanagawa Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kanagawa Dental University
Address 82 Inaoka-cho, Yokosuka, Kanagawa
Tel 046-822-1500
Email takemura@kdu.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
2019 Year 09 Month 28 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 31 Day
Date of IRB
2018 Year 12 Month 27 Day
Anticipated trial start date
2019 Year 09 Month 27 Day
Last follow-up date
2023 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
2019 Year 09 Month 26 Day
Last modified on
2021 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043441

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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