The aim of the present study is to compare the effect of ketoprofen and benzocaine patches in reduction of pain after separator placement. This study will be conducted as a double-blind controlled randomized clinical trial.
24 cases will be selected from patients referred to orthodontic department of dental school of Shahid Beheshti university of medical sciences and two private offices for fix orthodontic treatment. To eliminate individual differences in the experience of pain research will be conducted as a split mouth trial.
After separator placement, patients will take benzocaine and ketoprofen patches and all subjects will be instructed to use the patches ever 6 hours until 3 days after separator placement. Patches were randomly placed in right and left sides of the jaw. Patients will recorde their pain perception at times of 2 h, 6h, 24h, day2(6 pm), day3(10am and 6 pm) and day7(10 am and 6 pm) using 100 scores visual analogue scale. Eventually pain perception of patients will be assessed with respect of type of the applied patches and statistical analyses.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020316466N1
Registration date:2014-04-17, 1393/01/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-17, 1393/01/28
Registrant information
Name
Ladan Eslamian
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3010
Email address
ladan.eslamian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Dentofacial Deformities Research Center of shahid behehti university of medical sciences
Expected recruitment start date
2014-02-24, 1392/12/05
Expected recruitment end date
2014-05-26, 1393/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between efficacy of ketoprofen and benzocaine patches on post orthodontic pain
Public title
Prevention of orthodontic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: participants, in good general health without any reported systematic diseases; no concurrent use of analgesics and anti-inflammatory drugs; requiring banding of posterior teeth and placement of two or more elastomeric separators as a part of orthodontic treatment; caries-free dentition with healthy periodontium and without any endodontic problems in the posterior part of the mouth; presence of antagonist teeth in the opposite arch and absence of posterior open bite and interdental spaces. Patients were excluded from the study if they used analgesics and anti-inflammatory drugs during the study, did not complete the questionnaire, did not use or improperly used benzocaine or ketoprofen patches,or removed elastomeric separators.
Age
From 11 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
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
shahid beheshti university of medical science-dental univerity
Street address
Chamran Exp.way,Daneshjoo blvd
City
tehran
Postal code
19834
Approval date
2012-04-21, 1391/02/02
Ethics committee reference number
471
Health conditions studied
1
Description of health condition studied
Orthodontic pain
ICD-10 code
XXI
ICD-10 code description
Factors influencing health status and contact with health services
Primary outcomes
1
Description
pain
Timepoint
2 h, 6h, 24h, day2(6 pm), day3(10am and 6 pm) and day7(10 am and 6 pm)
Method of measurement
100 scores visual analogue scale
Secondary outcomes
1
Description
production
Timepoint
2 h, 6h, 24h, day2(6 pm), day3(10am and 6 pm) and day7(10 am and 6 pm)
Method of measurement
visual analogue scale
Intervention groups
1
Description
benzocaine patch, each 6 hours 1 patch until 3 days
The patches contained: Benzocaine(C9H11NO2) ,propylen glycol,di chloro methan,aspartam,poly vynil prolidine,ethanol and hydroxy proppyl methyl cellulose.Solvent casting was performed to make patches.At first the materials are weighted and solve in one proper solvent,then are mixed by magnetic mixer ( Heidolph stirrer, model:MR3001K, Germany)for 30 minutes. If no sediment observed, and the solution is clear ,each 50 cc will be placed in the same sized plates for 48hours under the hood for evaporation.To prevent contamination, a funnel should be placed above the plates; with reducing the speed of dissolving, the contents of the films would not migrate and the final homogenity of the film will be maintained.Hydroxy propyl methyl cellulose and polyvinyl prolidin will provide proper viscousity for the film to adher to oral mucosa.Propyl glycol is used for lavigation of Benzocaine or Ketoprufrn.Dichloro methan and ethanol solvents will be used to disolve the polymers after lavigation.To sweeten the films and making their taste more acceptable, Aspartam will be added.When the apperance of the provided material(film) is acceptable, they are cut into 0.5 x 1.5 cm pieces and hold in periapical radiographic film covers.In each section 2 films are placed. For each patient 12 Benzocaine and 12 ketoprufen patches are needed and the patients have to use them for 3 days.
After placement of elastic separators in proximal of right and left 1st molars, the patients will be instructed to use the keto and benzo patches on both sides of the arch simultaneously to perform a split-mouth study.Since pain is subjective , split-mouth study reduces the individual differences. Pilot study was performed to make certain that the two patches do not mix to reduce the study value.
The patients and the operator would not know which patch contain which element and the patches will be divided to A and B to make the study a double blind one and the patches will be randomly assigned to right and left sides by coin method.The amount of pain will be assessed by VAS scores(0 to 100) and the patients will fill the questioners at the determined times : 2,6 ,12 and 24hours, day 2 and day 3( at 10 am and 6 pm) after separator placement. The amount of pain in scores will be calculated for the two patches and the difference reported.
Category
Treatment - Drugs
2
Description
ketoprpfen patch , each 6 hours 1 patch until 3 days
The patches contained: Ketoprufen(C16H14O3), propylen glycol,di chloro methan,aspartam,poly vynil prolidine,ethanol and hydroxy proppyl methyl cellulose.Solvent casting was performed to make patches.At first the materials are weighted and solve in one proper solvent,then are mixed by magnetic mixer ( Heidolph stirrer, model:MR3001K, Germany)for 30 minutes. If no sediment observed, and the solution is clear ,each 50 cc will be placed in the same sized plates for 48hours under the hood for evaporation.To prevent contamination, a funnel should be placed above the plates; with reducing the speed of dissolving, the contents of the films would not migrate and the final homogenity of the film will be maintained.Hydroxy propyl methyl cellulose and polyvinyl prolidin will provide proper viscousity for the film to adher to oral mucosa.Propyl glycol is used for lavigation of Benzocaine or Ketoprufrn.Dichloro methan and ethanol solvents will be used to disolve the polymers after lavigation.To sweeten the films and making their taste more acceptable, Aspartam will be added.When the apperance of the provided material(film) is acceptable, they are cut into 0.5 x 1.5 cm pieces and hold in periapical radiographic film covers.In each section 2 films are placed. For each patient 12 Benzocaine and 12 ketoprufen patches are needed and the patients have to use them for 3 days.
After placement of elastic separators in proximal of right and left 1st molars, the patients will be instructed to use the keto and benzo patches on both sides of the arch simultaneously to perform a split-mouth study.Since pain is subjective , split-mouth study reduces the individual differences. Pilot study was performed to make certain that the two patches do not mix to reduce the study value.
The patients and the operator would not know which patch contain which element and the patches will be divided to A and B to make the study a double blind one and the patches will be randomly assigned to right and left sides by coin method.The amount of pain will be assessed by VAS scores(0 to 100) and the patients will fill the questioners at the determined times : 2,6 ,12 and 24hours, day 2 and day 3( at 10 am and 6 pm) after separator placement. The amount of pain in scores will be calculated for the two patches and the difference reported.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Eslamian orthodontic office
Full name of responsible person
Dr. Ladan Eslamian
Street address
#60,Satari bvd, Africa Blvd
City
Tehran
2
Recruitment center
Name of recruitment center
Orthodontic Department of Shahid Beheshti Univercity of Medical Science
Full name of responsible person
Dr. Ladan Eslamian- Mrs Foomani
Street address
Chamran exp.way. Daneshjoo blvd.
City
Tehran
3
Recruitment center
Name of recruitment center
Dr. Naseh dental office
Full name of responsible person
Dr. Roya Naseh
Street address
City
Qazvin
4
Recruitment center
Name of recruitment center
Dr. Haqiqat Naseri dental office
Full name of responsible person
Dr. Sara Haqiqat Naseri
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dentofacial Deformities Research Center of Shahid Beheshti University of Medical Science
Full name of responsible person
Dr.asghar Ebadifar
Street address
Shahid Beheshti Dental School
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dentofacial Deformities Research Center of Shahid Beheshti 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
Shahid Beheshti Universiy of Medical Sciences-Private office
Full name of responsible person
Hamide Motaharifard- Dr. Naseh
Position
Dental student-Orthodontist
Other areas of specialty/work
Street address
Chamran Exp.way,Daneshjoo blvd-dehkhod street
City
Tehran-Qazvin
Postal code
19834
Phone
+98 21 2240 3070
Fax
Email
motaharifar.h@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahi Beheshti University of Medical Sciences, Dental & pharmacology schools
Full name of responsible person
Ladan Eslamian- Seyed Alireza Mortazavi
Position
Professor of Orthodontics-Professor of Pharmaceutics PhD
Other areas of specialty/work
Street address
Chamran Exp.way, Daneshjoo blvd-Chamran Exp.way, Across Vali-asr Ave.
City
Tehran
Postal code
19834
Phone
+98 21 2990 2304
Fax
Email
leslamian@gmail.com; alirmortazavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Orthodontics, Warwick Dentistry, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, U
Full name of responsible person
Ali Borzooabadi Farahani-Arash Farzan
Position
DDS, MScD (Cardiff), MOrth RCS (Ed)-Postgraduate student of orthodontics
Other areas of specialty/work
Street address
Warwick Dentistry, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK - Chamran Exp.way-Daneshjoo blvd
City
Londan-Tehran
Province
London-Tehran
Postal code
Phone
00447803514186-00982129902304
Fax
Email
faraortho@yahoo.com; dr.arash.farzan@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)