UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003017 |
|---|---|
| Receipt number | R000003661 |
| Scientific Title | Evaluation of analgesic effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on odontalgia -development of a standard evaluation method- |
| Date of disclosure of the study information | 2010/01/12 |
| Last modified on | 2011/07/15 19:32:36 |
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Basic information
Public title
Evaluation of analgesic effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on odontalgia -development of a standard evaluation method-
Acronym
Evaluation of analgesic effect of NSAIDs on odontalgia -development of a standard evaluation method-
Scientific Title
Evaluation of analgesic effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on odontalgia -development of a standard evaluation method-
Scientific Title:Acronym
Evaluation of analgesic effect of NSAIDs on odontalgia -development of a standard evaluation method-
Region
| Japan |
Condition
Condition
Odontalgia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine a standard evaluation method to evaluate the effectiveness of analgesics on odontalgia using Visual Analogue Scale (VAS) and to develop [criteria for the effectiveness of analgesics on odontalgia].
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patient estimates their pain degree before and 15 min, 30 min, 1 h, 2 h, 3 h and 5 h after the administration of analgesics, and evaluates the effectiveness, rapidity and duration of the analgesic effect based on predesignated 4 ranks of patient' s satisfaction.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1.Pain originated from dentin or dental pulp.
Dentin hypersensitivity
Pulpitis
Tooth fracture
2.Pain originated from periodontal tissue.
Gingivitis
Periodontitis
Abscess
Tooth injury
Periapical periodontitis
Alveolitis
3.Pain caused by tooth eruption.
Pericoronitis
Key exclusion criteria
1.Patients under treatment for peptic ulcer
2.Patients with a severe heart/kidney/ liver/blood disorder
3.Patients who have experienced aspirin-induced asthma or drug allergy.
4.Patients with influenza
5.Patients who received medication or pain treatment for diseases of the tooth or periodontal tissue just before their visit.
6.Patients taking analgesics for other diseases.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Suda |
Organization
Tokyo Medical and Dental University
Division name
Pulp Biology and Endodotics
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549
TEL
03-5803-5492
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Wadachi |
Organization
Tokyo Medical and Dental University
Division name
Pulp Biology and Endodotics
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549
TEL
03-5803-5494
Homepage URL
http://www.jsotp.org/
r.wadachi.endo@tmd.ac.jp
Sponsor or person
Institute
Japanese Society of Oral Therapeutics and Pharmacology
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Oral Therapeutics and Pharmacology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nihon University School of Dentistry
Tokyo Dental College
Nippon Dental University School of Life Dentistry at Tokyo
Osaka Dental University
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
| 2010 | Year | 01 | Month | 12 | 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
| 2009 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Random sample
Management information
Registered date
| 2010 | Year | 01 | Month | 12 | Day |
Last modified on
| 2011 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003661
| Research Plan | |
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| 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 |
