Objectives: The aim of this study is the comparison of analgesic effect of Novafen ® versus Ibuprofen on pain relief after periodontal procedures. Major inclusion and exclusion criteria: Patients at the age range of 16 to 40 years with chronic moderate to severe generalized periodontitis who requires pocket elimination surgery will be enrolled into the study; patients with systemic, mental or hemorrhagic diseases, patients with addiction to alcohol or any other psychoactive substances and patients with known sensitivity to non-steroidal anti-inflammatory drugs, acetaminophen or caffeine will be excluded from the study. Study population: a number of 70 patients with chronic generalized periodontitis who will randomly be assigned into two equal groups. Intervention: the patients in intervention group will be asked to use Novafen® capsules immediately after the surgery and every 6 hours for 3 days, the patients in control group will also be asked to use ibuprofen 400 milligrams tablets immediately after the surgery and every 6 hours for 3 days. Main outcome variables: toothache after 30 minutes, 1 and 3 hours, and after 1, 2 and 3 days after the surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070918425N1
Registration date:2014-09-01, 1393/06/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-01, 1393/06/10
Registrant information
Name
Amir reza Babaloo
Name of organization / entity
Faculty of dentistry,Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
babaloo@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of analgesic effect of Novafen versus Ibuprofen on pain relief after periodontal surgery
Public title
Comparison of analgesic effects of Novafen versus ibuprofen on pain relief after periodontal surgeries.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being at the age range of 16 to 40 years; suffering from chronic generalized periodontitis which requires pocket elimination surgery.
Exclusion criteria: suffering from any systemic or mental diseases; addiction to alcohol or any other psychoactive substance; known sensitivity to non-steroidal anti-inflammatory drugs, caffeine or acetaminophen; suffering from any hemorrhagic disorder.
Age
From 16 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences and health services
Street address
Central office of Tabriz University of Medical Sciences, Daneshgah street, Golgasht street, Tabriz, Iran
City
Tabriz
Postal code
5165687386
Approval date
2014-06-14, 1393/03/24
Ethics committee reference number
9340
Health conditions studied
1
Description of health condition studied
The correlation of analgesic effect of Novafen versus Ibuprofen on pain relief after periodontal surgeries.
ICD-10 code
K08.8
ICD-10 code description
Toothache NOS
Primary outcomes
1
Description
Toothache after periodontal pocket elimination surgery
Timepoint
After 30 minutes, 1 hour and 3 hours after surgery by visual analogue scale (VAS) and after 1,2 and 3 days after surgery by verbal rating scale (VRS)
Method of measurement
Visual analogue scale (VAS) and verbal rating scale (VRS)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Ibuprofen 400 milligram tablets, immediately after the surgery and every 6 hours for 3 days
Category
Treatment - Drugs
2
Description
Intervention group: Novafen capsule (containing acetaminophen 325 mg, ibuprofen 200 mg and caffeine 40 mg) immediately after the surgery and every 6 hours for 3 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry clinic of Tabriz dentistry faculty
Full name of responsible person
Dr. Amirreza Babaloo
Street address
Periodontics ward, Dentistry clinic of Tabriz dentistry faculty, Tabriz faculty of dentistry, Daneshgagh street, Golgasht street, Tabriz, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for reserach, Tabriz university of medical sciences
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Vice chancellor for reserach, Central building of Tabriz University of Medical Sciences, Daneshgah street, Golgasht street, Tabriz, Ira
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reserach, Tabriz university of medical sciences