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IRCT20140527017880N7 IRCT 2018-11-08 Kermanshah University of Medical Sciences Determining the effect of low-level laser therapy on reducing the injection pain Investigating the effect of low-level laser therapy on pain reduction of anterior maxillary infiltration injection 2018-07-10 anticipated 84 Complete https://irct.ir/trial/33332 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Randomization is a simple method meaning that the selected units have the equal chance of been chosen. Random unit is of individual type and choosing and random instruments are selected envelopes for which the selection process can be carried out by lottery or by person. In this way, the patients are provided with two sets of envelopes. One set includes 84 envelopes: 42 A and 42 B (A: right and B: left) and the other set includes 84 envelopes: 42 C and 42 D (C: intervention side and D: Control side) and then each patient by choosing two envelopes from each set will determine the intervention or control side in the first run and at the next run the reverse is carried out, Blinding description: First, the patient chooses one of the C or D envelopes (C: laser radiation with power of 100 mw, D: laser radiation with power of 0 mw as placebo), then the first executor adjusts the laser device according to the patient-selected envelope, and eventually the second executor adjusts the low-level laser without noticing the patient's choice and immediately does the injection. Then, the patient determines the pain intensity by the use of the visual analog index, and then the analyst analyzes the information without knowing the codes. Blinding is done only by one of the researchers. Therefore, the patient, the injector and the analyst won't find out whether the laser has been radiated or not. N/A Local anesthesia. Intervention 1: Intervention group: first laser with power of 100 mw is radiated. The characteristics of the laser are as follow: low-level laser from Quick Laser with simultaneous radiations (810 and 980 nm), power of 12 w, manufactured by England Quick Laser Company, with the energy of 4 j/cm2 and cross section of 225 mm2 that is applied to the mucous membrane in a vertical form throughout the method of contact with no pressure texture in 90 seconds by a dentist. Then immediately, a 4% lidocaine carpool (epinephrine 1:100000, Iran Daroo Pakhsh) will be injected. All the injections will be carried out under the same circumstances in the depth of vestibule and adjacent to the root of maxillary’s central tooth by a dentist (The bull of the needle’s point should be toward the bone, the needle should be short 27 and the depth of needle penetration should be 2-4 mm and the time of carpool evacuation should be 1 minute). Intervention 2: Control group: first laser with power of 0 mw is radiated as plascebo. The characteristics of the laser are as follow: low-level laser from Quick Laser with simultaneous radiations (810 and 980 nm), power of 12 w, manufactured by England Quick Laser Company, with the energy of 4 j/cm2 and cross section of 225 mm2 that is applied to the mucous membrane in a vertical form throughout the method of contact with no pressure texture in 90 seconds by a dentist. Then immediately, a 4% lidocaine carpool (epinephrine 1:100000, Iran Daroo Pakhsh) will be injected. All the injections will be carried out under the same circumstances in the depth of vestibule and adjacent to the root of maxillary’s central tooth by a dentist (The bull of the needle’s point should be toward the bone, the needle should be short 27 and the depth of needle penetration should be 2-4 mm and the time of carpool evacuation should be 1 minute). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Hosna Bahrami
Across from the post office, Shora st, Dr Shariati st
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3722 2400 bahrami.h1994@gmail.com Kermanshah University of Medical Sciences scientific Dr Roohollah Sharifi
Across from the post office, Shora st, Dr Shariati st
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3722 7151 roholahsharifi@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) General health Absence of pathologic lesion at the injection site Age range from 20 to 25 years In need of restoration or root treatment 20 years 25 years Both Allergy to Lidocaine injectable drug Use of any sedative and anti-depression drugs in two weeks period Y48.3 Local anaesthetics Treatment - Devices Treatment - Devices Intervention group: first laser with power of 100 mw is radiated. The characteristics of the laser are as follow: low-level laser from Quick Laser with simultaneous radiations (810 and 980 nm), power of 12 w, manufactured by England Quick Laser Company, with the energy of 4 j/cm2 and cross section of 225 mm2 that is applied to the mucous membrane in a vertical form throughout the method of contact with no pressure texture in 90 seconds by a dentist. Then immediately, a 4% lidocaine carpool (epinephrine 1:100000, Iran Daroo Pakhsh) will be injected. All the injections will be carried out under the same circumstances in the depth of vestibule and adjacent to the root of maxillary’s central tooth by a dentist (The bull of the needle’s point should be toward the bone, the needle should be short 27 and the depth of needle penetration should be 2-4 mm and the time of carpool evacuation should be 1 minute). Control group: first laser with power of 0 mw is radiated as plascebo. The characteristics of the laser are as follow: low-level laser from Quick Laser with simultaneous radiations (810 and 980 nm), power of 12 w, manufactured by England Quick Laser Company, with the energy of 4 j/cm2 and cross section of 225 mm2 that is applied to the mucous membrane in a vertical form throughout the method of contact with no pressure texture in 90 seconds by a dentist. Then immediately, a 4% lidocaine carpool (epinephrine 1:100000, Iran Daroo Pakhsh) will be injected. All the injections will be carried out under the same circumstances in the depth of vestibule and adjacent to the root of maxillary’s central tooth by a dentist (The bull of the needle’s point should be toward the bone, the needle should be short 27 and the depth of needle penetration should be 2-4 mm and the time of carpool evacuation should be 1 minute). Pain intensity of infiltration injection. Timepoint: Immediately after injection. Method of measurement: Based on the Visual Analogue Scale. Kermanshah University of Medical Sciences Approved 2018-08-15 Ethics Committee of Kermanshah University of Medical Sciences Ethics Committee, Vice Chancellor for Research and Technology, Building No.2, Kermanshah University of Medical Sciences, Shahid Beheshti Boulverd Kermanshah Kermanshah Iran (Islamic Republic of)