The purpose of this study is to compare the effect of laser and Gelofen in reducing pain after separator placement . The study is double blind and the patients randomly select their group by taking a paper from pocket. The number of patients are 60 ranged between 13 -25 years old . An hour before separator placement 30 patients receive one dose of Gelofen and instantly after placement receive laser facade. The remaining 30 patients receive placebo and LLLT laser in the same way.Patients should not have systemic disease and also should not have history of orthodontic treatment. The primary outcome variable is the amount of pain reduction after separator placement .The second outcome variable is to compare the effect of laser and Gelofen in reducing pain after separator placement .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061316582N2
Registration date:2016-10-31, 1395/08/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Vahid Mollabashi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3835 2555
Email address
mollabashi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical comparison of Gelofen drug and low power diode laser effect on pain induced by orthodontic separator implementation
Public title
comparison of analgesic drug and laser effect on pain reduction after orthodontic separator implementation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients between13-25 years old;Female patients not to be pregnant; Patients with no orthodontic treatment history; Patients with no gelofen reaction history in the drug group; In the drug group the minimum weight should be 40 kg.
Exclusion criteria: patients with history of systemic disease; Patients with periodontal disease, More than 3 mm Probing depth; Attached gingiva recession; Using antibiotic in drug group .
Age
From 13 years old to 25 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
Ethics committee,Hamedan University of Medical Sciences
Street address
Orthodontic Department, School of Dentistry, Shahid Fahmideh street, Hamedan
City
Hamedan
Postal code
38677-65178
Approval date
2016-06-11, 1395/03/22
Ethics committee reference number
IR.UMSHA.REC.1395.150
Health conditions studied
1
Description of health condition studied
orthodontic pain
ICD-10 code
K08.9
ICD-10 code description
Disorder of teeth and supporting structures, unspecified
Primary outcomes
1
Description
The pain after seprator placement
Timepoint
Immediately after the intervention, 6 hours after intervention, 12 hours after intervention, 24 hours after intervention,2 days after intervention,3 days or more after intervention
Method of measurement
Questionnaire Modified McGill
Secondary outcomes
empty
Intervention groups
1
Description
In drug group patients receive 400mg Gelofen an hour before placing separator between the contacts of maxillary molars and after placement using laser facade flash without therapeutic effect .
Category
Treatment - Drugs
2
Description
In the laser group patients receive placebo of the Gelofen an hours before placement of separator between the contacts of maxillary molars.Immediately after separator placement laser will expose to three points of apex, mesial and distal.
Laser properties include: Wavelength 940nm
Exposure Time 20 seconde
Exposure Dose 4j/cm2
Power 45 mw.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Dr.Vahid Mollabashi
Street address
Departemant of Orthodontic, Dental Callege, Shahid Fahmide street, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Hamedan University of Medical Science
Full name of responsible person
Dr. Said Bashirian
Street address
School of Medicine, Shahid Fahmide Street, Hamedan
City
Hamedan
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 and Technology, Hamedan University of Medical Science
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
Hamedan University of Medical Sciences
Full name of responsible person
vahid mollabashi
Position
Assistant Professor
Other areas of specialty/work
Street address
Orthodontic Department, School of Dentistery, Shahid Fahmide Street, Hamedan
City
Hamedan
Postal code
38677-65178
Phone
+98 81 3838 0130
Fax
Email
vahidmolabashi@yahoo.com
Web page address
mollabashi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan of Medical Science
Full name of responsible person
Dr.vahid mollabashi
Position
Assistant professor
Other areas of specialty/work
Street address
Hamedan، Shahid Fahmide Street, Dental Callege, Department of Orthodontic
City
Hamedan
Postal code
38677-65178
Phone
+98 81 3838 0130
Fax
Email
vahidmolabashi@yahoo.com
Web page address
mollabashi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr.vahid mollabashi
Position
Assistant professor
Other areas of specialty/work
Street address
Orthodontic Department,School of Dentistery,Shahid Fahmide Street,Hamedan
City
Hamedan
Postal code
38677-65178
Phone
+98 81 3838 0130
Fax
Email
vahid.mollabashi@gmail.com
Web page address
mollabashi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)