The objective of this study is to evaluate the analgesic efficacy of Celecoxib Versus Prednisolone for the prevention and control of pain after periodontal surgery. This study is a randomized, double-blind, cross-over, placebo-controlled trial, on 20 patients with generalized, moderate to severe chronic periodontitis, aged 20 years or older and have three mucoperiosteal flaps with minor osseous surgery under local anesthesia, at least 4 weeks apart. Each quadrant is randomly assigned to receive one of the following interventions: 200 mg Celecoxib one hour before surgery and 12 hours after the first dose, 10 mg Prednisolone one hour before surgery and 8 hours after the first dose, or placebo. The medications are coded and delivered to the patients by and individual not aware of the research process. The patients will fill out a visual analog scale (VAS) and a five-point verbal rating scale (VRS-5), every hour for the first 8 hours after surgery and at three time points during the day after the surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138709051081N2
Registration date:2009-10-19, 1388/07/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-10-19, 1388/07/27
Registrant information
Name
Golpar Radafshar
Name of organization / entity
Guilan University of Medical Sciences, School of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 0775
Email address
golshad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Secretary of Reseach and Technology of Faculty of Dentistry, GUMS
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2010-02-20, 1388/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic Efficacy of celecoxib Versus Prednisolone For the Prevention and Control of Pain after Periodontal Surgery.
Public title
Effect of celecoxib on the reduction of pain after periodontal surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Otherwise healthy individuals having moderate to severe chronic periodontitis and Being a candidate for mucoperiosteal flap with minor osseous surgery in at least 3 quadrants of dentition
Exclusion criteria: Diabetes mellitus, uncontrolled hypertension, gastric ulcer, pregnancy or breast feeding, allergy to drugs consumed in the study, high risk for Infective Endocarditis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Amount of local anesthetic injection is the same for all patients and Surgery is done by a singel practitioner. Visual analogue Scale and a five -point verbal rating Scale are used for pain measurment. To eliminate effects of anxiety on pain reported by the patients, a Modified Dental anxiety Scale is used.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences, Research Secretary
Street address
Namjoo Blv. GUMS Building
City
Rasht
Postal code
Approval date
2009-04-18, 1388/01/29
Ethics committee reference number
پ/3/132/774
Health conditions studied
1
Description of health condition studied
Pain after periodontal surgery
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Pain severity
Timepoint
From the first hour after surgery for 8 hours, every hour, and at the morning, noon and night of the day after surgery ( 11 time points)