UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009805 |
|---|---|
| Receipt number | 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 17:24:36 |
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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
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
Sponsor or person
Institute
The Nippon Dental University School of Life Dentistry at Niigata
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011221
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
