This study was performed to evaluate prophylactic effect of Novafen and Gelofen on post endodontic treatments pain decrement. Patients who received treatment in Endodontic Dentistry Clinic, Dentistry School of Babol University Of Medical Sciences between the years of 2013-2014 were participated in this study. Inclusion criteria included: patients’ contentment and their ability for completing the forms. Exclusion criteria included: history of systemic disease; hypersensitivity to NSAIDs; and history of chronic use of analgesics or sedatives. The sample size of 60 was considered. One hour before treatment; 2 capsulles as placebo to the patients in control group, 2 200 mg Novafen capsulles to Novafen group, and 2 200 mg Gelofen capsulles to Gelofen group; were prescribed orally in order to pain decrement after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041316973N2
Registration date:2014-10-04, 1393/07/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-04, 1393/07/12
Registrant information
Name
Mohammad Kashefinejad
Name of organization / entity
Faculty of Dentistry, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 1408
Email address
m.kashefi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic effect of Novafen and Gelofen on post endodontic treatments pain decrement
Public title
evaluation of the effect of Novafen and Gelofen in post canal treatment pain decrement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1.The patient should be able to read , understand and complete the consent form; 2.Patient's consent form has been completed; 3.Teeth with a live pulp that do not have a peri-apical lesion should have been evaluated.
Exclusion criteria :
1.Pregnancy; 2.Hypersensitivity to NSAIDs and Sulfonamides; 3.History of asthma associated with nasal polyps; 4.History of chronic use of analgesics or sedatives; 5.Alcohol abuse; 6.Patients with uncontrolled hypertension; 7.Diabetes mellitus; 8.Renal disease, CNS disease, heart disease and liver dysfunction; 9.Cancer or major anomalies confirmed by clinical examinations or laboratory findings; 10.Aged less than 18 and more than 65; 11.Pregnancy or breastfeeding; 12.Analgesic use less than 12 hours to the beginning of the study.
Age
From 18 years old to 64 years old
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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Ganj Afrooz Ave. University Sq.
City
Babol
Postal code
4717641376
Approval date
2013-12-23, 1392/10/02
Ethics committee reference number
923698
Health conditions studied
1
Description of health condition studied
Pharmacokinetics
ICD-10 code
K04.9
ICD-10 code description
Other and unspecified diseases of pulp and periapical tissues
Primary outcomes
1
Description
pain
Timepoint
One hour before treatment
Method of measurement
4,8,12,24,48
Secondary outcomes
empty
Intervention groups
1
Description
In control group : Prescribed 2 capsules orally 1 hour before treatment as placebo