UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005067 |
|---|---|
| Receipt number | R000005892 |
| Scientific Title | Study of pain control for dental treatment by the density of diphenhydramine difference |
| Date of disclosure of the study information | 2011/02/15 |
| Last modified on | 2022/02/18 09:13:45 |
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Basic information
Public title
Study of pain control for dental treatment by the density of diphenhydramine difference
Acronym
Study of pain control for dental treatment by diphenhydramine
Scientific Title
Study of pain control for dental treatment by the density of diphenhydramine difference
Scientific Title:Acronym
Study of pain control for dental treatment by diphenhydramine
Region
| Japan |
Condition
Condition
Teeth are free of caries, large restrations, and periodontal disease
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
it is said an emergency visit for the laceration that a patient having an allergic history can treat by minor operation for local anesthetic when the diphenhydramine 1% solution is effective as substitute medicine of the local anesthetic.
We search the level whether analgesic effect is obtained by diphenhydramine when a patient having a history of the allergic reaction to local anesthetics undergoes dental treatment to require local anesthesia by this study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Confirmation of the anesthetic effect using a pulp tester
2)Time to analgesia manifestation
3)Duration of the analgesia
4)Circulatory dynamics
5)Presence and degree of the side effect manifestation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group D1
1.8mL of 1% difhenhydramine with 1:100,000 adrenarine
Interventions/Control_2
Group D1.5
1.8mL of 1.5% difhenhydramine with 1:100,000 adrenarine
Interventions/Control_3
Group D2
1.8mL of 2% difhenhydramine with 1:100,000 adrenarine
Interventions/Control_4
Group D1
1.8mL of 2% lidocaine with 1:100,000 adrenarine
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Written informed concent
Key exclusion criteria
1. The patient who has allergia to medicine to use in this examination
2.Pregnancy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kimito |
| Middle name | |
| Last name | SANO |
Organization
The Nippon Dental University achool of lifr Dentistry at Niigata
Division name
Department of Dental Anesthesia
Zip code
9518580
Address
1-8 Hamaura-cho, Chuo-ku, Niigata 951-8580,Japan
TEL
025-267-1500
yamada@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | YAMADA |
Organization
The Nippon Dental University achool of lifr Dentistry at Niigata
Division name
Department of Dental Anesthesia
Zip code
9518580
Address
1-8 Hamaura-cho, Chuo-ku, Niigata 951-8580,Japan
TEL
025-267-1500
Homepage URL
yamada@ngt.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University achool of lifr 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
The Nippon Dental University achool of lifr Dentistry at Niigata
Address
1-8 Hamaura-cho, Chuo-ku, Niigata 951-8580,Japan
Tel
0252671500
yamada@ngt.ndu.ac.jp
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
日本歯科大学新潟病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 15 | 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
| 2011 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 10 | Day |
Last modified on
| 2022 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005892
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