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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009805
Receipt No. R000011221
Scientific Title Development of new topical anesthetic method -the study of the starch wafer method-
Date of disclosure of the study information 2013/01/31
Last modified on 2013/01/29

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Basic information
Public title Development of new topical anesthetic method
-the study of the starch wafer method-
Acronym Development of new topical anesthetic method by the starch wafer method
Scientific Title Development of new topical anesthetic method
-the study of the starch wafer method-
Scientific Title:Acronym Development of new topical anesthetic method by the starch wafer method
Region
Japan

Condition
Condition adult
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The object of this study is the increase of efficacy in topical anesthetic and it searches about the activities in the starch wafer method of a various thickness
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The pain assessment during needle insertion (31G)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Covering starch wafer with 1 diameter of thick of 20 micrometers, after applying topical anesthesia to papillary gingiva of the right mandibular first molar
Interventions/Control_2 Covering starch wafer with 1 diameter of thick of 40 micrometers, after applying topical anesthesia to papillary gingiva of the left mandibular first molar
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 the adult fully explained about this study and consent was got
Key exclusion criteria the adult fully explained about this study and consent was not got
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimito SANO
Organization The Nippon Dental University School of Life Dentistry at Niigata
Division name Department of Anesthesiology
Zip code
Address 1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The Nippon Dental University School of Life Dentistry at Niigata
Division name Department of Anesthesiology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute The Nippon Dental University School of Life Dentistry at Niigata
Institute
Department

Funding Source
Organization Self funding
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
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
2013 Year 01 Month 31 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 Preinitiation
Date of protocol fixation
2013 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 02 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
2013 Year 01 Month 18 Day
Last modified on
2013 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011221

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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