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IRCT20211127053194N1 IRCT 2022-01-23 Tehran University of Medical Sciences- faculty of dentistry The effect of laser therapy on recovery of facial sensation after upper jaw surgery Evaluation the effect of photobiomodulation therapy with 810 nm Diode laser on the recovery of mid face sensation following maxillary Lefort 1 surgery: A triple-blind, split-face, randomized controlled trial 2022-06-22 anticipated 20 Complete https://irct.ir/trial/60279 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, using a simple randomization method with a table of random numbers, the intervention is assigned to one of the two right or left. In this way, in the table of random numbers from top to bottom, in case of collision with odd number, the intervention will be assigned to the right, and in case of collision with even number, the intervention will be assigned to the left. Move in the columns of the random number table from top to bottom until the number of samples is exhausted, Blinding description: During laser treatment, the patient will not feel any heat changes or pain during the laser treatment. The device probe is used on the control side with the same time as intended on the intervention side in off mode. The patient (according to the above points) will be blind to which side of the mouth he receives the laser from. The person who measures the results of the study will be blind to this allocation. Also, labels A and B are considered for both intervention and control so that the statistical analyst is blind to the end of the data analysis relative to the allocation. 3 neurosensory disorder after Lefort 1 surgery. Intervention 1: Intervention group: In the middle part of the face, on the intervention side, laser therapy will be done by an operator on days 1, 3, 7, 14, 21 and 28 after surgery, by GaAlAs diode laser device with wave length specifications of 810, power 250mW, in Continuous wave density energy density 12 J / cm2 made by Konftec, Co, Taipei, Taiwan. 13 points (each point with an area of 0.5 cm2 and for 24 seconds) will be irradiated from the upper lip vermilion to the ipsilateral zygoma. The handpiece of the laser device is in contact with the skin surface of the mentioned area and is applied with a little pressure. The patient will not feel any heat changes or pain during the laser treatment. Intervention 2: Control group: The probe of the device is used on the control side with the same time as intended on the intervention side and in places similar to laser therapy points on the intervention side, in off mode. 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 Because the participants have not been identified yet.
public Nima Dehghani
North Kargar St, Enghalab sq
Tehran Iran (Islamic Republic of) ۱۴۳۹۹۵۵۹۹۱ +98 21 4279 4500 nimadt۲۰۰۲@gmail.com School of Dentistry (Tehran University of Medical Sciences) scientific Nima Dehghani
North Kargar St, Enghalab sq
Tehran Iran (Islamic Republic of) ۱۴۳۹۹۵۵۹۹۱ +98 21 4279 4500 nimadt۲۰۰۲@gmail.com School of Dentistry (Tehran University of Medical Sciences) Iran (Islamic Republic of) No previous maxillofacial trauma Absence of oral diseases No uncontrolled systemic diseases Age between 18 and 40 years 18 years 40 years Both Existence or history of trauma or head and neck malignancies Pregnancy and lactation experiencing fractures or obvious nerve damage during surgery Postoperative infection Contraindication laser therapy R20.2 Disturbance of skin senation Treatment - Devices Placebo Intervention group: In the middle part of the face, on the intervention side, laser therapy will be done by an operator on days 1, 3, 7, 14, 21 and 28 after surgery, by GaAlAs diode laser device with wave length specifications of 810, power 250mW, in Continuous wave density energy density 12 J / cm2 made by Konftec, Co, Taipei, Taiwan. 13 points (each point with an area of 0.5 cm2 and for 24 seconds) will be irradiated from the upper lip vermilion to the ipsilateral zygoma. The handpiece of the laser device is in contact with the skin surface of the mentioned area and is applied with a little pressure. The patient will not feel any heat changes or pain during the laser treatment. Control group: The probe of the device is used on the control side with the same time as intended on the intervention side and in places similar to laser therapy points on the intervention side, in off mode. Score of 2 point discrimination test. Timepoint: day preoperative and then on days1,3,7,14,21,28 and 35 postoperative. Method of measurement: The points of calipers are held against the skin at different distances from each other. The test determines the minimal distance at which the patient can distinguish whether one or two points are in contact with the skin. This distance starts at 10 mm in the upper lip and 20 mm in the nasolabial fold, and gradually decreases by one millimeter each time the test is performed, until patient feel the 2 points as one point. The amount of distance that the patient first senses two points as one point is considered as an outcome. We will do this process 3 times and consider its average. Score of brush directional stroke test. Timepoint: Day preoperative and then on days1,3,7,14,21,28 and 35 postoperative. Method of measurement: brush directional stroke test consisted of performing ten horizontal or vertical movements with a micro brush tip on the marked points (about 1 cm) and ask for the patient to report the direction. The number of correct answers is recorded from the number of 10 tests performed. Score of thermal discrimination test. Timepoint: Day preoperative and then on days1,3,7,14,21,28 and 35 postoperative. Method of measurement: In this test, small glass tubes filled with cold water (15 degrees) and hot water (50 degrees) are used. The end of the tube is in contact with the desired point on the skin for 5 seconds and the patient is asked about the water temperature (hot or cold). Finally, after 10 tests, the number of correct answers is considered as the patient's score. Score of sharp blunt discrimination. Timepoint: Day preoperative and then on days1,3,7,14,21,28 and 35 postoperative. Method of measurement: This test is performed using a dental explorer 17/23 to test the sharp sense and a periodontal probe for the blunt sense. One of these two tools contacts the target point with a gentle pressure and the patient is asked about its feeling of being sharp or blunt, and at the end, the number of correct answers is recorded from 10. Score of visual analogue scale. Timepoint: Day preoperative and then on days1,3,7,14,21,28 and 35 postoperative. Method of measurement: The level of patient satisfaction with the restoration of sensation in the middle of the face is indicated by a number between 0 and 10. student Approved 2021-10-02 Ethics committee of Tehran University of Medical Sciences- faculty of dentistry Faculty of dentistry (TUMS), ST north Kargar, Tehran Tehran Iran (Islamic Republic of)