This randomized double blind Clinical trial study was accomplished to compare the analgesic effect of Celecoxib 200mgand Gelofen 400 mg on post endodontic pain. Ninety patients in 3 groups (30 patients in each group) recruited. In a double blind study, capsules of Celecoxib, Gelofen and Placebo were randomly prescribed to the patients 1 hour before treatment. Patient reported visual analog Scale rating of pain intensity, were used upon initial clinical presentation and patients were asked to record their pain at 4, 8, 12, 24 and 48 hours after intervention. Inclusion criteria were: age between 18 to 65; and having vital premolars of mandible or maxilla without any pre apical lesion and exclusion criteria were: pregnancy; allergy to sulfonamide and NSAIDs; history of asthma related to nasal polyp; history of chronic using of analgesics; alcohol using; uncontrollable high blood pressure; diabetes mellitus; systemic disease and not using analgesic medicine 12 hours before study. Primary outcome of the study was the pain after surgery and measured by pain visual analogous scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106306926N1
Registration date:2011-07-23, 1390/05/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-23, 1390/05/01
Registrant information
Name
Shaghayegh Nooribayat
Name of organization / entity
Babol Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 220 0198
Email address
sh.nooribayat@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz Univecity of Medical Science
Expected recruitment start date
2009-07-27, 1388/05/05
Expected recruitment end date
2009-12-27, 1388/10/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of pretreatment by Celecoxib and Gelofen on post endodontic pain
Public title
Efficacy of pretreatment by medicines on post endodontic pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 65; and having vital premolars of mandible or maxilla without any pre apical lesion
Exclusion criteria: pregnancy; allergy to sulfonamide and NSAIDs; history of asthma related to nasal polyp; history of chronic using of analgesics; alcohol using; uncontrollable high blood pressure; diabetes mellitus; systemic disease and not using analgesic medicine 12 hours before study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
The Office of Research, 7th floor, Main building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
2359317711
Approval date
2009-06-26, 1388/04/05
Ethics committee reference number
705
Health conditions studied
1
Description of health condition studied
Endodontic pain
ICD-10 code
K08.9
ICD-10 code description
Disorder of teeth and supporting structures, unspecified
Primary outcomes
1
Description
Pain
Timepoint
4, 8, 12, 24 and 48 hours after intervention
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Gelofena as capsule 400 mg, oral, one dose 2 houres before starting the treatment
Category
Treatment - Drugs
2
Description
placebo as capsule, oral one dose 2 houres before starting the treatment
Category
Placebo
3
Description
Celecoxib as capsule 200mg, per oral one dose 2 houres before starting the treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodintics department, Dental Faculty, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Mirzaie
Street address
Resident of radiology, Babol Denatal Faculty
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Street address
The Office for Research, 7th floor, Main building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dental student of Research Committee, Dental Faculty, Babol University of Medical Sciences
Full name of responsible person
Shaghayegh Nooribayat
Position
Student of Dentistry, Research Committee, Dental Faculty, Babol University of Medical Sciences
Other areas of specialty/work
Street address
Research Committee, Dental Faculty, Babol University of Medical Sciences