The aim of this study was to evaluate the effect of preoperative administration of Novafen in pain relief after periodontal surgeries. The target population of this study are patients who are Candidate for crown lengthening surgery and 70 patients of them will be selected. The patients will be divided into two groups randomly. This study will be double-blinded. The first group immediately before periodontal surgery receive Novafen capsules (containing 325 mg of acetaminophen, 200 mg of ibuprofen and 40 mg caffeine) and second group receive placebo (starch). After surgery, all patients will use ibuprofen. On the other hand, at least four hours before treatment, patients should not take other painkillers. Pain severity of patients will be recorded 30 minutes, 1 and 3 hours after surgery by VAS (visual analgesic scale) scale and one, two and three days later by VRS (verbal rating scale) scale. Patients with a history of systemic or mental disease; addiction to alcohol or any mind-altering substance; known sensitivity to NSAID, acetaminophen or caffeine will exclude from study. Finally the data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062822951N1
Registration date:2015-08-04, 1394/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-04, 1394/05/13
Registrant information
Name
milad Ghanizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5921
Email address
milad.ghanizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-07-30, 1394/05/08
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preoperative administration of Novafen in pain relief after periodental surgeries
Public title
administration of Novafen capsules for prevention of the postoperative pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:A consent to inclusion; In the age range 16 to 40 years; Patients candidate for crown lengthening surgery. Exclusion criteria: Systemic disease or mental; Addiction to alcohol or any mind-altering substance; Known sensitivity to NSAID, acetaminophen or caffeine.
Age
From 16 years old to 40 years old
Gender
Both
Phase
N/A
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz,Iran
City
Tabriz
Postal code
Approval date
2015-07-29, 1394/05/07
Ethics committee reference number
Tbzmed.rec.1394.370
Health conditions studied
1
Description of health condition studied
Periodontal surgery
ICD-10 code
K00-K14
ICD-10 code description
Diseases of oral cavity, salivary glands and jaws
Primary outcomes
1
Description
Pain severity
Timepoint
1,2 and 3 days after Intervention
Method of measurement
Based on verbal rating scale
2
Description
Pain severity
Timepoint
30 minutes,1 and 3 hours after Intervention
Method of measurement
Based on visual analgesic scale
Secondary outcomes
empty
Intervention groups
1
Description
Patients will receive a Novafen capsules (containing 325 mg of acetaminophen, 200 mg ibuprofen and 40 mg caffeine) immediately before periodontal surgery. All drugs are manufactured by Alhavy pharmaceutical company (Tehran, Iran) in blinded label packages. All of the patients after surgery only will use ibuprofen painkiller.
Category
Treatment - Drugs
2
Description
Patients wiil receive a Placebo (containing Starch) immediately before periodontal surgery. All drugs are manufactured by Alhavy pharmaceutical company (Tehran, Iran) in blinded label packages. All of the patients after surgery only will use ibuprofen painkiller.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Professional Department of Periodontology, School of Dentistry, Tabriz University of Medical Scienc
Full name of responsible person
Dr. Atrabak Kashefi Mehr
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz,Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Edliye Shirmohammadi
Street address
Tabriz University of Medical Sciences,Golgasht Avenue, Azadi Street,Tabriz,Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Atabak Kashefimehr
Position
Specialist in Periodontics/ Academic Staff
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz,Iran
City
Tabriz
Postal code
Phone
+98 41 3544 0754
Fax
Email
milad.ghanizadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Atabak Kashefimehr
Position
Specialist in Periodontics/ Academic Staff
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz,Iran
City
Tabriz
Postal code
Phone
+98 41 3544 0754
Fax
Email
milad.ghanizadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hatef Mollazadeh
Position
Dentistry student
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz,Iran
City
Tabriz
Postal code
Phone
+98 41 3544 0754
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)