UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of dental anxiety of patients on wisdom tooth extraction
Title of the study (Brief title)	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	Shiro Mataki
Organization	Tokyo Medical and Dental University
Division name	Behavioral Dentistry, Graduate school,
Address	1-5-45Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5889
Email	matadiag@tmd.ac.jp

Public contact
Name of contact person	Ken-ichi Tonami
Organization	Tokyo Medical and Dental University
Division name	Oral Diagnosis and General Dentistry, Dental Hospital
Address	1-5-45Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5566
Homepage URL
Email	ken1.gend@tmd.ac.jp

Sponsor
Institute	Behavioral Dentistry, Graduate school, Tokyo Medical and Dental University
Institute
Department

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

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025655