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Efficacy of prophylactic use of Sulindac in comparison with Ibuprofen on post-operative endodontic pain

Protocol summary

Summary
In this clinical trial study, 48 patients with average age of 25-50 years who were medically healthy were selected. The study was done on vital anterior single root canal teeth with severe decay and spontaneous pain at range of 0-30 in visual analogue scale (VAS) but without periapical lesion (radiographically), swelling, or fistula. The patients were allocated into three groups matched for sex to receive 400 mg Ibuprofen (Aria, Tehran, Iran), 200 mg Sulindac (Merksharp & dohm, USA) or placebo one capsule as prophylaxis 1 hour before treatment. The drugs were prepared identically as capsules. All patients will receive standard treatments with identical method. In addition, the patients were given two acetaminophen codeine 300/10 mg tablets for severe continuous post-operative pain. Intensity of pain is recorded by the patients through Visual Analogue Scale 6, 12, 24, 48, and 72 hours after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138809222847N1
Registration date: 2010-06-22, 1389/04/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-22, 1389/04/01
Registrant information
Name
Mohammad Mahdi Yaghooti Khorasani
Name of organization / entity
Dental School, Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0031
Email address
dr.yaghooti@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of prophylactic use of Sulindac in comparison with Ibuprofen on post-operative endodontic pain
Public title
Efficacy of prophylactic use of Sulindac in comparison with Ibuprofen on post-operative endodontic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of vital anterior single root canal teeth with severe decay and spontaneous pain at range of 0-30 in VAS, Patient who are medically healthy, positive responses to pulpal tests (thermal testes and pulp tester) Exclusion criteria: Presence of periapical lesion (in radiography), swelling, or fistula, contraindications to study drug consumption, receiving analgesics 12 hours before the treatment
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
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
Ethical committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd.
City
Rafsanjan
Postal code
7717933777
Approval date
2010-05-11, 1389/02/21
Ethics committee reference number
9/20/223

Health conditions studied

1

Description of health condition studied
post-operative endodontic pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
post-operative pain
Timepoint
6, 12, 24, 48, & 72 hours after treatment
Method of measurement
Visual Analog Scale

Secondary outcomes

empty

Intervention groups

1

Description
400mg Ibuprofen (Aria,Tehran,Iran) one hour before the treatment
Category
Treatment - Drugs

2

Description
Placebo, one capsule one hour before the treatment
Category
Placebo

3

Description
The third group were given one capsule containing 200 mg Sulindac(Merksharp&dohm,USA) before the treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental office of Dr Mahmud Motamedinejad
Full name of responsible person
Dr Mahmud Motamedinejad
Street address
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ali Shamsizade
Street address
Rafsanjan University of Medical Sciences, Imam Ali BLV
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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 school, Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Mohammad Mahdi Yaghooti Khorasani
Position
Assistant professor
Other areas of specialty/work
Street address
Dental School, Shahid Mofateh Blvd
City
Rafsanjan
Postal code
Phone
+98 39 1822 0031
Fax
Email
m.yaghooti@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental school, Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Mohammad Mahdi Yaghooti Khorasani
Position
Endodontist
Other areas of specialty/work
Street address
Dental School,Shahid Mofateh BLV
City
Rafsanjan
Postal code
Phone
+98 39 1822 0031
Fax
Email
m.yaghooti@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr Mohammad Mahdi Yaghooti Khorasani
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 39 1822 0031
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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