The objective of this study was to compare the effect of pretreatment with lbuprofen, Indomethacin , and placebo on postoperative pain of mandibular molars with irreversible pulpitis. In this study 150 adult patients with a diagnosis of irreversible pulpitis in their mandibular molars referred to the Department of Endodontics of Kerman Dental School for treatment, were invited to participate. Pure powder of drugs were provided from drug manufactures and placed in similar capsules by pharmacologist in similar bottles which contain either 600 mg Ibuprofen, 75 mg Indomethacin, or placebo (500 mg lactos monohydrate). Postoperative pain was measured using the Heft–Parker Visual Analogue Scale (VAS) during 48 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811082016N3
Registration date:2010-02-20, 1388/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-20, 1388/12/01
Registrant information
Name
Masoud Parirokh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1245 7931
Email address
m_parirokh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The Oral and Dental research Center and Research Committee of Kerman University of Medical Sciences
Expected recruitment start date
2009-05-18, 1388/02/28
Expected recruitment end date
2010-02-01, 1388/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of pretreatment with lbuprofen, Indomethacin, and placebo on postoperative pain of mandibular molars with irreversible pulpitis.
Public title
Comparison the effect of pretreatment with lbuprofen, Indomethacin, and placebo on postoperative pain of mandibular molars with irreversible pulpitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 18 years, no contraindications to taking either Ibuprofen or Indomethacin (history of any allergic reaction to aspirin, NSAIDS, or Lidocaine with Epinephrine, nasal polyp, history of peptic ulcers or GI bleeding, pregnancy and lactation, renal or hepatic disease), no history of GI disorders or ulcer, having no serious systemic disease.
Exclusion criteria: no response to cold test, having sensitivity to percussion and palpation, having radiographic changes such as PDL widening, lack of vital pulp in coronal pulp chamber access cavity preparation, the teeth with large restoration, teeth with evidence of crack in their crown, presence of periapical radiolucency, internal resorption or calcification, and also taking narcotic drugs or analgesic drugs in recent 12 hours before treatment.
Age
From 18 years old to 100 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethic Committee of Kerman University of Medical Science
Street address
Vice-chancellor for Research, Kerman University of Medical Sciences, Tahmaseb-abad cross, Jahad Street,
City
Kerman
Postal code
76174
Approval date
2009-05-18, 1388/02/28
Ethics committee reference number
k/88/299
Health conditions studied
1
Description of health condition studied
Postoperative pain
ICD-10 code
KO4
ICD-10 code description
Diseases of pulp and periapical tissues
Primary outcomes
1
Description
Postoperative pain
Timepoint
6, 12, 24, and 48 hours after the procedure
Method of measurement
Using Heft-Parker -Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Ibuprofen, 1 capsule of 600 mg, 1 hour before injection of the local anesthetic
Category
Treatment - Drugs
2
Description
Indomethacin, 1 capsule of 75 mg,1 hour before the local anesthetic injection)1 hour before injection of the local anesthetic
Category
Treatment - Drugs
3
Description
Placebo: 1 capsule contain 500 mg lactos mono hydrate,1 hour before the local anesthetic injection)1 hour before injection of the local anesthetic
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Dental Research center
Full name of responsible person
Dr.Masoud Parirokh
Street address
Endodontic Department, Kerman Dental School, Shafa Street
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oral and Dental Research Center and Vice-Chancellor for Research of Kerman University of Medical Sci
Full name of responsible person
Mrs. Hasani
Street address
Vice-Chancellor for Research Building,Tahmasbabad cross, Jahad Street,
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oral and Dental Research Center and Vice-Chancellor for Research of Kerman University of Medical Sci
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
Kerman University of Medical Sciences
Full name of responsible person
Nozar Nakhaee
Position
Resrach Manager/ Associate professor/PHD of epidemiology
Other areas of specialty/work
Street address
Tahmasbabad cross, Jahad Street, Vice Chancellor for Research Building
City
Kerman
Postal code
76175
Phone
+98 34 1226 3815
Fax
+98 34 1211 8073
Email
nakhaeen@yahoo.com
Web page address
www.kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masoud Parirokh
Position
Professor of endodontics
Other areas of specialty/work
Street address
Endodontic Department, Kerman dental School, Shafa street
City
Kerman
Postal code
76175
Phone
+98 34 1245 7931
Fax
+98 34 1211 8073
Email
M_Parirokh@kmu.ac.ir, masoudparirokh@gmail.com
Web page address
www.kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rezvan Ashouri
Position
Postgraduate student
Other areas of specialty/work
Street address
NO 13, Shafa street, Kerman
City
Kerman
Postal code
7618648955
Phone
+98 34 1244 8509
Fax
+98 34 1211 8073
Email
ashouri77@gmail.com
Web page address
www.kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)