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IRCT20180930041179N1 IRCT 2018-12-21 Bagheiat-allah University of Medical Sciences Effect of low level laser on nerve healing Effect of low – level laser irradiation on healing process of lower lip hypoesthesia following sagittal split ramus osteotomy 2017-10-12 anticipated 40 Complete https://irct.ir/trial/34173 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be divided into the groups in an individual simple random sampling (SRS) manner. In this order random number table will be used. Any of 500 referred patients to the hospital who need orthognathic surgery will have a number. These numbers will be put in the number table without any pattern and totally disorderly. The numbers are found by a second blinded person in order to allocation concealment. At first a point is selected to start. By default, the direction from left to right is set. By moving on the table each number will be recorded which is the person who is included in the study. By default, numbers under 250 are included in the intervention group and numbers over 250 are included in control group. This process will be continued until 40 patients (sample size) are completed, Blinding description: Every patient is included in control or intervention group randomly and is not informed about that.In control group the probe is used whilst the laser unit is off. In this order the patients will not understand that whether the laser is irradiated or not and are blinded to the survey. The examiner who assesses the outcomes is not aware that each patient is whether in the intervention group or not. Actually the study is designed to be double blinded. N/A Neurosensory disturbance in facial area. Intervention 1: Intervention group: Laser irradiation would be performed immediately, 24 hours, 48 hours, and 72 hours following surgery. Laser therapy is continued three times a week in the next two weeks (total 10 sessions). Diode laser wavelength is 810 nm, the power density is 8.4 j/cm2, power is 70 mW, and the beam diameter is 8mm. Intervention 2: Control group: Laser irradiation would be performed immediately, 24 hours, 48 hours, and 72 hours following surgery. Laser therapy is continued three times a week in the next two weeks (total 10 sessions).probe is used whilst the laser unit is off. 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 more information exist.
public Mohammad Esmaeelinejad
Faculty of Dentistry, Semnan University of Medical Sciences, Hefdah Shahrivar St., Saadi square
Semnan Iran (Islamic Republic of) ۳۵۱۳۱۳۸۱۱۱ +98 23 3332 4700 esmaeelnejad@gmail.com Semnan University of Medical Sciences scientific Mohammad Esmaeelinejad
Faculty of Dentistry, Semnan University of Medical Sciences, Hefdah Shahrivar St., Saadi square
Semnan Iran (Islamic Republic of) ۳۵۱۳۱۳۸۱۱۱ +98 23 3332 4700 esmaeelnejad@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Patients who undergo sagittal split osteotomy surgery. Nerve damage is as neuropraxia. No technical error is occurred during surgery. No previous facial surgery is mentioned. No previous nerve damage is mentioned. Patients are not medically compromised. Patients do not consume anticonvulsants and antidepressants drugs. no limit no limit Both History of previous orthognathic surgery History of neurosensory disturbance in the facial area Inappropriate surgical technique or complication occurrence Neurotmesis or axonotmesis happening Medically compromised patients Uncooperative patients G50.8 Other disorders of trigeminal nerve Treatment - Devices Placebo Intervention group: Laser irradiation would be performed immediately, 24 hours, 48 hours, and 72 hours following surgery. Laser therapy is continued three times a week in the next two weeks (total 10 sessions). Diode laser wavelength is 810 nm, the power density is 8.4 j/cm2, power is 70 mW, and the beam diameter is 8mm. Control group: Laser irradiation would be performed immediately, 24 hours, 48 hours, and 72 hours following surgery. Laser therapy is continued three times a week in the next two weeks (total 10 sessions).probe is used whilst the laser unit is off Patient’s satisfaction. Timepoint: One, three, six, and twelve months after laser therapy. Method of measurement: Visual Analogue Scale. Pinprick test. Timepoint: One, three, six, and twelve months after laser therapy. Method of measurement: Pinprick test; is defined as the patient’s ability to identify the sharp needle touching the affected skin. Dental probe is used for this test with the constant force. Thermal test. Timepoint: One, three, six, and twelve months after laser therapy. Method of measurement: Thermal test; which is defined as the patient’s ability to discern either the heat or cool probe. Small glass tubes containing water at15°C and 50°C are used. The perception of either cold or hot stimulus is recorded. Two-point discrimination. Timepoint: One, three, six, and twelve months after laser therapy. Method of measurement: Two-point discrimination test; which is defined as the patient’s ability to detect the two nearby objects contacting the face skin truly two distinct points, not one. A calibrated drawing compass was used with minimum error (reproducibility more than 95%). Bagheiat-allah University of Medical Sciences Approved 2016-10-03 Ethics committee of Baqiatallah University of Medical Sciences Vice chancellor for research, Baqiyatallah university, Sheikhbahaei Ave., Molasadra Ave., Vanak square Tehran Tehran Iran (Islamic Republic of)