UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022049 |
|---|---|
| Receipt number | R000025418 |
| Scientific Title | Analgesic effects of Emla cream as topical anesthetic for gingiva. |
| Date of disclosure of the study information | 2016/07/31 |
| Last modified on | 2017/10/26 12:57:29 |
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Basic information
Public title
Analgesic effects of Emla cream as topical anesthetic for gingiva.
Acronym
Analgesic effects of Emla cream as topical anesthetic for gingiva.
Scientific Title
Analgesic effects of Emla cream as topical anesthetic for gingiva.
Scientific Title:Acronym
Analgesic effects of Emla cream as topical anesthetic for gingiva.
Region
| Japan |
Condition
Condition
Dental medicine
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the analgesic effect of Emla cream applied to gingiva.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
I evaluate it by a change of Visual Analogue Scale, the vital signs after pricking gingiva with needle.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Emura group: Emura cream have applied 20 minutes before pucture with needle.
Interventions/Control_2
Ethyl aminobenzoate group: I puncture with a 25G needle after ethyl aminobenzoate have applied.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults.
Key exclusion criteria
People who has paralysis on their faces. People who are allergic to local allergy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoka Matsumura |
Organization
Tokyo Medical and Dental University Dental Hospital.
Division name
Dental Anesthesiology
Zip code
Address
1-5-45 Yushima Bunkyou-ku Tokyo Japan.
TEL
03-5803-5549
tomoanph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoka Matsumura |
Organization
Tokyo Medical and Dental University Dental Hospital.
Division name
Dental Anesthesiology
Zip code
Address
1-5-45 Yushima Bunkyou-ku Tokyo Japan.
TEL
03-5803-5549
Homepage URL
tomoanph@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University Graduated school Anesthesiology and Clinical Physiology.
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
| 2016 | Year | 07 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 30 | 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 | 04 | Month | 25 | Day |
Last modified on
| 2017 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025418
| 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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