In this clinical trial study mandibular molars with irreversible pulpitis were endodontically treated in 66.The medicines were prepared similarly in the form of capsules containing 400 mg Ibuprofen (group A), 25 mg indomethacin (group B) and placebo (group C). The patients were given one capsule 1 h before the start of treatment. Patients recorded their pain measured by a visual analogue scale (VAS) at medication time, during treatment and 8, 12 and 24 h after treatment.
Ibuprofen and indomethacin significantly reduced the postoperative pain in comparison with placebo during treatment and 8 h after treatment; however, there was no significant difference between them at 12 and 24 h after treatment. premedication with ibuprofen and indomethacin can effectively control the postoperative pain; less side effect and more analgesic influence of ibuprofen make it the superior choice
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010712048N1
Registration date:2016-01-05, 1394/10/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-05, 1394/10/15
Registrant information
Name
Zeinab Hamzeheil
Name of organization / entity
Shahid Sadoughi University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1625 6975
Email address
z.hamzeheil@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University Of Medical Sciences
Expected recruitment start date
2011-07-20, 1390/04/29
Expected recruitment end date
2012-02-14, 1390/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Indomethacin and Ibuprofen on postoperative Endodontic pain in referring patients to the Endodontic department with dental pain
Public title
Effect of premedication with Indomethacin and Ibuprofen on postoperative Endodontic pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with first and second molars with irreversible pulpitis having normal radiographic view without any lesion or fistula؛ exhibit a long response to the pulp tester and cold testing
exclusion criteria: individual younger than 18 years and older than 50 years؛ Consumption of analgesic drug 12 hours before treatment؛ Allergic history to NSATDs or Lidocaine with 1/80000 Epinephrine؛ patients with systemic disease؛ Take contraindicated drugs with NSAIDs؛Pregnancy and nursing؛ teeth with periapical lesion or acute periapical abscess؛ aggressive periodontal disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Shahid Sadoughi University of Medical Science
Street address
Central Department of University, Bahonar Square
City
Yazd
Postal code
Approval date
2009-08-15, 1388/05/24
Ethics committee reference number
۱۷/۱/پ/۴۶۲۱۰
Health conditions studied
1
Description of health condition studied
Effect of premedication with Indomethacin and Ibuprofen on postoperative endodontic pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The analgesic effect
Timepoint
8,12,24 hours after treatment
Method of measurement
By Visual Analogus Scale(VAS)
Secondary outcomes
1
Description
Gastritis
Timepoint
After treatment
Method of measurement
Grade (low, intermediate, high)
Intervention groups
1
Description
Indomethacin/25mg/capsule/1 hours befor treatment
Category
Treatment - Drugs
2
Description
Ibuprofen/400mg/capsule/1 hours befor treatment
Category
Treatment - Other
3
Description
Placebo/capsule/1 hours before treatment
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Fatemeh Ezodini
Street address
Yazd Shahid Sadoughi University of Medical Sciences, Dental School, Fazaye sabz Crossroad, Dahe-fajr Blv, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahid Sadoughi 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
Shahid Sadoughi University of Medical Science
Full name of responsible person
Zeinab Hamzeheil
Position
Dentist
Other areas of specialty/work
Street address
Fzaye Sabz, Dental School, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1625 6975
Fax
Email
n_hamzeiil@yahoo.com; z.hamzeheil@ssu.ac
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Fatemeh Mokhtari
Position
Endodontics
Other areas of specialty/work
Street address
Fazaye Sabz, Dental School, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1625 6975
Fax
Email
mokhtari.f.d@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Zeinab Hamzeheil
Position
Dentist
Other areas of specialty/work
Street address
Fazaye Sabz, Dental School, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1625 6975
Fax
Email
n_hamzeiil@yahoo.com; z.hamzeheil@ssu.ac
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)