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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003017
Receipt No. 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

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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
Email

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/
Email r.wadachi.endo@tmd.ac.jp

Sponsor
Institute Japanese Society of Oral Therapeutics and Pharmacology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003661

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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