UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027992 |
|---|---|
| Receipt number | R000025655 |
| Scientific Title | Study of dental anxiety of patients on wisdom tooth extraction |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2017/06/29 13:49:15 |
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Basic information
Public title
Study of dental anxiety of patients on wisdom tooth extraction
Acronym
Patients anxiety on wisdom tooth extraction
Scientific Title
Study of dental anxiety of patients on wisdom tooth extraction
Scientific Title:Acronym
Patients anxiety on wisdom tooth extraction
Region
| Japan | Asia(except Japan) |
Condition
Condition
Pericoronitis of wisdom tooth
Impacted wisdom tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify relation between patients' background and physiological stress during wisedom tooth extraction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Correlation between activity of synthetic /parasynthetic nerve and patients' back ground such as gender, age and result of psychological test.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
No experience of teeth extraction
Key exclusion criteria
Pessess underlying disease such as heart desease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Mataki |
Organization
Tokyo Medical and Dental University
Division name
Behavioral Dentistry, Graduate school,
Zip code
Address
1-5-45Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5889
matadiag@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Tonami |
Organization
Tokyo Medical and Dental University
Division name
Oral Diagnosis and General Dentistry, Dental Hospital
Zip code
Address
1-5-45Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5566
Homepage URL
ken1.gend@tmd.ac.jp
Sponsor or person
Institute
Behavioral Dentistry, Graduate school, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Behavioral Dentistry, Graduate school, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
UNIVERSITY OF MEDICINE AND
PHARMACY AT HO CHI MINH CITY
Name of secondary funder(s)
UNIVERSITY OF MEDICINE AND
PHARMACY AT HO CHI MINH CITY
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
503/UMP-BOARD
Org. issuing International ID_1
Board of Ethics in Biomedial Reserch, Ministry of Health, University of Medicine and Pharmacy at Ho Chi Minh City
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
University Hospital,
UNIVERSITY OF MEDICINE AND
PHARMACY AT HO CHI MINH CITY
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research is planned to reveal validity of frequency analysis of heart rate as stress monitor.
Management information
Registered date
| 2017 | Year | 06 | Month | 29 | Day |
Last modified on
| 2017 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025655
