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IRCT20220227054137N1 IRCT 2022-03-15 Kermanshah University of Medical Sciences Evaluation of the effect of low power laser in reducing injection pain Evaluation of the effect of low power laser in reducing the pain of mandibular block injection in restorative patients 2022-02-23 anticipated 59 Complete https://irct.ir/trial/62392 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done only in the first session in a simple and individual way. A table of random numbers is used for randomization. In Excel software environment, four-digit codes are generated using the RANDBETWEEN command. Each patient is assigned a 4-digit code that if the end digit to the right of the code is 1, 2, 5, 7, 9, at the first visit, they will be given laser radiation, and if the end digit of the code is 0, 3, 4, 6, 8 In the second visit, laser radiation is performed for them. All codes are recorded on paper and stored in specific envelopes. The envelopes are arranged randomly and the responsible secretary, who is aware of the objectives of the study, will give them one of these envelopes before entering the doctor's room when reviewing the inclusion criteria and recording patient information.The secretary is not aware of the study hypothesis and is not aware of the details of the codes for assigning to groups. The doctor will decide on the treatment process for the patient based on the specified code, Blinding description: This study is designed in two forms. Patients are not exposed to the laser radiation. For this purpose, when the laser is not irradiated, the device is still on, which makes the patient unaware of whether the device is on or not by making a sound. Also, the outcome assessor is not in the process of allocating patients. Therefore, they are also unaware of how to allocate. N/A Evaluation of the effect of low power laser in reducing the pain of mandibular block injection. Intervention group: For each patient, two injections of alveolar block in the posterior area of ​​both sides of the mandible will be performed twice in two weeks. In the first session, for all patients, mandibular molar restoration is performed on the right side. For this purpose, using a table of random numbers, people are divided into two groups: laser and placebo. In the second session, restoration is performed on the left tooth and the methods are changed in such a way that patients who received a laser in the first session receive a placebo on the left side and patients who received a placebo receive a placebo this time on the left side. Left receive the laser. The interval between the first and second session is at least two weeks. The patient opens his mouth wide.We see a mucosal protrusion from almost behind the upper tuberosity, which extends to the back of the lower 7 tooth and is called the trigomandibular ridge. Near the trigeminal raphe is where the needle enters the corner of the mouth and about 2 cm of the needle is inserted to hit the bone. In the control group, the device is on, but the laser is not emitted. In fact, the patient is not aware that the laser is on or off and hears the false sound of the device.Settings of low power laser device with specifications: low power laser, quick lase 810nm + 980nm, 12w Dual cw (manufactured by Quick Liz UK, energy 0.3 joules, time s240, cross section 225 mm2, by contact method without pressure Apply perpendicular to the contact area by the first performer and immediately inject a 4% carpol lidocaine (epinephrine 1: 100000).. 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 No decision has been made yet on the release of the information.
public Zohreh Rahimi
Kermanshah, Daneshgah St., School of Medicine, Vice Chancellor for Research and Technology
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 9917 Zrahimi@kums.ac.ir Kermanshah University of Medical Sciences scientific Elahee vlaee
Boostan Dormitory , Zakaria Razi Blv
Kermanshah Iran (Islamic Republic of) 7461168617 +98 83 3428 1374 elahev9@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) General health Insensitivity to lidocaine injection No use of any analgesics, anesthesia, sedation and antidepressant for two weeks No pregnancy no limit no limit Both Lack of cooperation Sensitivity to the injectable drug If for any reason during the intervention more than one injection is applied for each person Cancellation of the participants Very high and low pain threshold N/A Intervention group: For each patient, two injections of alveolar block in the posterior area of ​​both sides of the mandible will be performed twice in two weeks. In the first session, for all patients, mandibular molar restoration is performed on the right side. For this purpose, using a table of random numbers, people are divided into two groups: laser and placebo. In the second session, restoration is performed on the left tooth and the methods are changed in such a way that patients who received a laser in the first session receive a placebo on the left side and patients who received a placebo receive a placebo this time on the left side. Left receive the laser. The interval between the first and second session is at least two weeks. The patient opens his mouth wide.We see a mucosal protrusion from almost behind the upper tuberosity, which extends to the back of the lower 7 tooth and is called the trigomandibular ridge. Near the trigeminal raphe is where the needle enters the corner of the mouth and about 2 cm of the needle is inserted to hit the bone. In the control group, the device is on, but the laser is not emitted. In fact, the patient is not aware that the laser is on or off and hears the false sound of the device.Settings of low power laser device with specifications: low power laser, quick lase 810nm + 980nm, 12w Dual cw (manufactured by Quick Liz UK, energy 0.3 joules, time s240, cross section 225 mm2, by contact method without pressure Apply perpendicular to the contact area by the first performer and immediately inject a 4% carpol lidocaine (epinephrine 1: 100000). Measurement of pain during injection of mandibular alveolar nerve block. Timepoint: Start of study and 14 days after intervention. Method of measurement: The method of measuring pain intensity is the use of a visual analog scale. Kermanshah University of Medical Sciences Approved 2022-02-23 Ethics committee of kermanshah University of Medical Sciences Boostan dormitory , zakaria Razi Blv Kermanshah Kermanshah Iran (Islamic Republic of)