1) Objectives
The aim of this study is to investigating the effect of Gelofen prescription in reduction of pain after impacted third molar surgery that with choose best time to prescribe is decreased the pain problem after surgery.
2) Design
Research with design of clinical trial, randomized controlled and split mouth. All patients who have indication for impacted tooth extraction of mandible in two side and after justification of design, and declare their agreement to cooperation with this plan, and have not been any problem for surgery, will be examined.
3) Procedure
Each side of patients’ mandible were divided into experimental group (prescription before surgery) and control group (prescription after surgery). Gelofen 400mg will prescribed for each group. By questioning of patients, when begin their pain after surgery, and that have received the first painkiller tablet, become distinguished and recorded, and also by asking patients will determined and recorded the number of used painkiller in 12 hours. Time of pain appearing (when first tablet used) and also the number of used tablet in two group assessed by t-test. For experimental group prescribed Gelofen 400mg half an hour before surgery and for control group which will done in next section, prescribed a Gelofen 400mg immediately after surgery.
This study will be done on 20 person (40 sample).
4) Participants
Inclusion criteria
Patients who have been indication for impacted tooth extraction of mandible in two side with same dormancy and express their consciously tendency to cooperation with this plan.
Exclusion criteria
Present of peri coronal acute and chronic inflammation; used tablet except considered tablet; pregnant person; having systematic problems; individuals who used steroid medicine, anti-depressant and antibiotics; individuals who have prohibition to this used medicine.
5) Interventions
One side of patient’s mandible appointed experimental group and the other side was control group. For control group prescribed Gelofen half an hour before surgery and for experimental group prescribed Gelofen immediately after surgery.
6) Main outcome variables
Main variables were the time of pain beginning and the number of used tablet in 12 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030732929N1
Registration date:2017-05-16, 1396/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-16, 1396/02/26
Registrant information
Name
Fina Navi
Name of organization / entity
Islamic Azad University Tehran Dental Branch
Country
Iran (Islamic Republic of)
Phone
+98 912 201 5179
Email address
f_navi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad Univercity Tehran Dental Branch
Expected recruitment start date
2016-12-24, 1395/10/04
Expected recruitment end date
2017-05-10, 1396/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of prescription Gelofen before and after impacted mandibular third molar surgery on the onset and duration of pain after surgery.
Public title
The effect of Gelofen prescription in reduction of pain after impacted wisdom teeth surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria
Patients who have been indication for impacted tooth extraction of mandible in two side with same dormancy and express their consciously tendency to cooperation with this plan.
Exclusion criteria
Present of peri coronal acute and chronic inflammation; used tablet except considered tablet; pregnant person; having systematic problems; individuals who used steroid medicine, anti-depressant and antibiotics; individuals who have prohibition to this used medicine.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Islamic Azad Univercity Tehran dental Branch
Street address
10th Neistan, Pasdaran street
City
Tehran
Postal code
Approval date
2016-11-26, 1395/09/06
Ethics committee reference number
IR.IAU.DENTAL.REC.1395,10
Health conditions studied
1
Description of health condition studied
Impacted tooth
ICD-10 code
K01.1
ICD-10 code description
An impacted tooth is a tooth that has failed to erupt because of obstruction by another tooth.
Primary outcomes
1
Description
Time of pain appearing
Timepoint
Till 12 hour after surgery
Method of measurement
Ask the patient and registered.
2
Description
Number of tablet used
Timepoint
Till 12 hour after surgery
Method of measurement
Ask the patient and registered.
Secondary outcomes
empty
Intervention groups
1
Description
Half an hour before surgery prescribed Gelofen tablets 400 mg for exprimental group.
Category
Treatment - Drugs
2
Description
Immediately after surgery prescribed Gelofen tablets 400 mg for control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad Univercity Tehran Dental Branch
Full name of responsible person
Eshagh Lasemi
Street address
10th Neistan, Pasdaran street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad Univercity Tehran Dental Branch
Full name of responsible person
Dr Arash Azizi
Street address
10th Neistan street, Pasdaran street
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, Islamic Azad Univercity Tehran Dental Branch
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
Islamic Azad Univercity Tehran Dental Branch
Full name of responsible person
Fina Navi
Position
Faculty member
Other areas of specialty/work
Street address
10th Neistan street, Pasdaran street
City
Tehran
Postal code
Phone
+98 21227663460
Fax
Email
f_navi@dentaliau.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad Univercity Tehran Dental Branch
Full name of responsible person
Fina Navi
Position
Maxillofacial surgeon
Other areas of specialty/work
Street address
10th Neistan street, Pasdaran street
City
Tehran
Postal code
Phone
+98 21 2276 3460
Fax
Email
f_navi@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)