]>
IRCT2014020316466N1 IRCT 2014-04-17 Dentofacial Deformities Research Center of Shahid Beheshti University of Medical Science Prevention of orthodontic pain A comparison between efficacy of ketoprofen and benzocaine patches on post orthodontic pain 2014-02-24 anticipated 24 Complete https://irct.ir/trial/15398 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Orthodontic pain. Intervention 1: 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. Intervention 2: 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.
public Hamide Motaharifard- Dr. Naseh
Chamran Exp.way,Daneshjoo blvd-dehkhod street
Tehran-Qazvin Iran (Islamic Republic of) 19834 +98 21 2240 3070 motaharifar.h@gmail.com Shahid Beheshti Universiy of Medical Sciences-Private office scientific Ladan Eslamian- Seyed Alireza Mortazavi
Chamran Exp.way, Daneshjoo blvd-Chamran Exp.way, Across Vali-asr Ave.
Tehran Iran (Islamic Republic of) 19834 +98 21 2990 2304 leslamian@gmail.com; alirmortazavi@yahoo.com Shahi Beheshti University of Medical Sciences, Dental & pharmacology schools Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 11 years 35 years Both XXI Factors influencing health status and contact with health services Treatment - Drugs Treatment - Drugs 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. 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. 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. 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. Dentofacial Deformities Research Center of Shahid Beheshti University of Medical Science Approved 2012-04-21 shahid beheshti university of medical science-dental univerity Chamran Exp.way,Daneshjoo blvd tehran Iran (Islamic Republic of)