Pain and discomfort during and after Root canal therapy is the most bothering part of the endodontic treatment. Many drugs have been prescribed to control or eliminate this pain, most of which have undesirable side-effects. Among these; ibuprofen (50-800 mg) has the most decreasing effect on postendodontic pain. Gastro-intestinal problems, are of most important side-effects of NSAIDs . Zintoma a product from Zingiber Officinale has Anti-inflammatory and subsequently analgesic impressions. This study compares the prophylactic effect of Zintoma on postendodontic pain in teeth with irreversible pulpitis, with that of Ibuprofen and placebo. 90 patients who are to be endodontically treated and volunteer to participate in this Double-blind placebo controlled clinical study were randomly assigned into three thirty-person groups. The main inclusion criteria of this study are; irreversible pulpitis of lower first and second molars needing RCT with VAS of 5 or more, ages between 18 and 65 and no history of conflicting disease. The intervention of this study is drug consumption and main outcome measure is pain severity reported by the patient
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903174116N1
Registration date:2010-10-10, 1389/07/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-10, 1389/07/18
Registrant information
Name
Mohsen Ramazani
Name of organization / entity
Babol university of medical sciences- Faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 32354390111
Email address
m.ramzani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The prophylactic effect of Zintoma and Ibuprofen in Post-Endodontic pain
Public title
Comparison of The prophylactic effect of Zintoma and Ibuprofen in Post-Endodontic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1: Age between 18 and 65
2: No history of the following diseases: mitral valve prolapse, myocardial rheumatism, artificial valve or joint, myocardial infarction, brain stroke, uncontrolled hypertension, hepatitis, seizure, bleeding disorders, peptic ulcer, liver or kidney diseases
3: No history of allergy to NSAIDs or Zingiber Officinale
4: No pregnancy, no breast feeding
5: No other drug consumption at least four hours before study commense
6: Severity of spontaneous pain must be at least five
7: Patients ability to read, comprehend and complete the questionaire and VAS
8; completion of informed consent
Age
From 19 years old to 64 years old
Gender
Both
Phase
N/A
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
university of medical sciences
Street address
Ganjafrooz avenue
City
Babol
Postal code
4717647745
Approval date
empty
Ethics committee reference number
30.1391.ژ.پ
Health conditions studied
1
Description of health condition studied
Diseases of pulp and periapical tissues
ICD-10 code
K04.0
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
before intervention and 4, 8, 12, 24, 48 and 72 hours after intervention
Method of measurement
using VAS registration questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Placebo group: 1.5 hour before treatment, 2 placebo capsules are used and 1 hour later, ie 0.5 hour before treatment another 2 placebo capsules are used
Category
Placebo
2
Description
Ibuprofen group: 0.5 hour before treatment, 1 capsule containing 400 mg ibuprofen is used
Category
Treatment - Drugs
3
Description
Zintoma group: 1.5 hour before treatment two 500 mg zintoma capsules are used and 1 hour later, ie 0.5 hour before treatment another two 500 mg zintoma are used
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical sciences, Faculty of Dentistry
Full name of responsible person
Dr Mohsen Ramazani
Street address
Ganjafrooz avenue, Medical University, Faculty of Dentistry, Endodontic Department
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Dr Amrollah Mostafazadeh
Street address
Ganjafrooz avenue-Uneversity of Medical sciences- Faculty of dentistry-Depatment of Endodontics
City
Babol
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, Babol 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
Babol Medical University- Faculty of Dentistry
Full name of responsible person
Mohsen Ramazani
Position
Post Graduate Student
Other areas of specialty/work
Street address
Ganjafrooz avenue, Medical University, Faculty of Dentistry, Endodontic Department
City
Babol
Postal code
-
Phone
+98 11 1222 4032
Fax
-
Email
m.ramzani@mubabol.ac.ir
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohsen Ramazani
Position
Post Graduate Student
Other areas of specialty/work
Street address
Ganjafrooz avenue, Medical University, Faculty of Dentistry, Endodontic Department
City
Babol
Postal code
-
Phone
+98 11 1222 4032
Fax
-
Email
m.ramzani@mubabol.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohsen Ramazani
Position
Post Graduate Student
Other areas of specialty/work
Street address
Ganjafrooz avenue, Medical University, Faculty of Dentistry, Endodontic Department
City
Babol
Postal code
-
Phone
+98 11 1222 4032
Fax
-
Email
m.ramzani@mubabol.ac.ir
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)