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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024084
Receipt No. R000027702
Scientific Title The effect of dental topical anesthetic with aroma.
Date of disclosure of the study information 2016/10/01
Last modified on 2018/08/20

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Basic information
Public title The effect of dental topical anesthetic with aroma.
Acronym The effect of dental topical anesthetic with aroma.
Scientific Title The effect of dental topical anesthetic with aroma.
Scientific Title:Acronym The effect of dental topical anesthetic with aroma.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The porpose of this study is to investigate the effect of dental topical anesthetic with aroma for dental anxiety.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes State-Trait Anxiety Inventory (STAI)
Key secondary outcomes Blood pressure, Heart rate, Oxygen saturation of peripheral artery, Heart Rate Variability, Visual Analogue Scale, Salivary amylase, Questionnaires

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 2% Lidocaine jelly is selected as a topical anesthetics.
Interventions/Control_2 Prones-pasta-aroma is selected as a topical anesthetics.
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

Not applicable
Gender Male and Female
Key inclusion criteria Healty volunteers
Key exclusion criteria 1,Ethyl aminobenzoate allergy
2,Lidocaine allergy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sunada Katsuhisa
Organization The Nippon Dental University
Division name Dental Anesthesiology
Zip code
Address 1-9-20 Fujimi Chiyoda-ku Tokyo Japan
TEL 03-3261-6083
Email katsu.sunada@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Tsutsui Yukako
Organization The Nippon Dental University
Division name Dental Anesthesiology
Zip code
Address 1-9-20 Fujimi Chiyoda-ku Tokyo Japan
TEL 03-3261-6083
Homepage URL
Email tsutsuiy@tky.ndu.ac.jp

Sponsor
Institute The Nippon Dental University
Institute
Department

Funding Source
Organization Nippon Shika Yakuhin Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2016 Year 09 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

Management information
Registered date
2016 Year 09 Month 16 Day
Last modified on
2018 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027702

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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