The purpose of this study is Comparison of low dose Pregabalin versus Gelofen on postoperative pain reduction in third molar extraction patients. In this randomized, single blind clinical trial, a number of twenty five patients, 18 – 40 yr old, inclusion criteria: candidate for third molar extraction; lack of severe cardiac and mental disease; consent to take a share in the study and exclusion criteria: history of drug allergy; opiate and sedative use. According to the random numbers chart they are split into two groups: Pregabalin and Gelofen. At the end of surgery study group takes 75 milligram Pregabalin orally or 400 milligram Gelofen orally with a glass of water. Third molar extraction is performed by one surgeon with same surgical technique under local anesthesia. One month afterwards, the procedure will repeat for contralateral tooth and the drug will change. At the end of surgery before discharge, and every two hours until twelve hours after surgery, pain measure and record by a collaborator who does not know about grouping by using a visual index (Visual Analogue Scale) and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122131501N1
Registration date:2017-05-26, 1396/03/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-26, 1396/03/05
Registrant information
Name
Parsia Choubsaz
Name of organization / entity
Shahid Beheshti School of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 21 8861 6150
Email address
parsia.choubsaz@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Sahid Beheshti School of Dentistry
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative clinical trial of low dose Pregabalin versus Gelofen in decreasing postoperative pain in patients after mandibular third molar surgery
Public title
Effect of low dose Pregabalin versus Gelofen for postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: candidate for third molar extraction; lack of severe cardiac and mental disease; consent to take part in the study
Exclusion criteria: history of drug allergy; opiate use; sedative use
Age
From 18 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Randomization was performed by using random numbers chart
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shahid Beheshti University of Medical Sciences,
Street address
School of Dentistry, Daneshjoo Blvd, Evin, Shahid Chamran Highway
City
Tehran
Postal code
1983963113
Approval date
2017-02-18, 1395/11/30
Ethics committee reference number
IR.SBMU.RIDS.REC.1395.392
Health conditions studied
1
Description of health condition studied
Pain after third molar surgery
ICD-10 code
K010
ICD-10 code description
Embedded teeth
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, and every 2 hours in12 hours after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Pregabalin 75 mg oral capsules (lyrics -Pfizer company) with a glass of water at the end of surgery
Category
Prevention
2
Description
Control group:Gelofen 200 milligram oral capsules(Ibuprofen -Doona pharma company) with a glass of water at the end of surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sahid Beheshti School of Dentistry
Full name of responsible person
Dr. Azita Tehranchi
Street address
School of Dentistry, Daneshjoo Blvd, Evin, Shahid Chamran Highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Azita Tehranchi
Street address
School of Dentistry, Daneshjoo Blvd, Evin, Shahid Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciensec
Full name of responsible person
Parsia Choubsaz
Position
Dentistry student
Other areas of specialty/work
Street address
Department of Maxilofacial Surgery,Velenjak Hospital
City
Tehran
Postal code
Phone
+98 21 8861 6150
Fax
+98 21 8861 6149
Email
parsia.choubsaz@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciensec
Full name of responsible person
Dr. Fatemeh Latifi
Position
Maxilofacial surgeon,Assistant professor
Other areas of specialty/work
Street address
Department of Maxilofacial Surgery,Taleghani Hospital
City
Tehran
Postal code
Phone
+98 21 2240 3075
Fax
+98 21 2240 3194
Email
dr.f.latifi@gmail.com
Web page address
http://dentistry.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciensec
Full name of responsible person
Parsia Choubsaz
Position
Dentistry student
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 8861 6150
Fax
Email
parsia.choubsaz@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)