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IRCT20230619058536N1 IRCT 2023-07-06 Artesh University of Medical Sciences Comparison of Leukocyte Platelet-rich Fibrin And Low level laser on acceleration of neurosensory recovery following Genioplasty Comparison of Leukocyte Platelet-rich Fibrin And Low level laser on acceleration of neurosensory recovery following Genioplasty 2023-07-11 anticipated 16 Complete https://irct.ir/trial/70893 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: One side of the mandible is designated as intervention side and the other as the control side ,in the first patient right side will be chosen as intervention side and this will be continued in every other patient, Blinding description: On the control side, the laser probe will be turned off and will be placed on the designated area; the device will not be activated, so patients will not be aware of which side will being radiated by laser. neurosensory evaluation will be performed by a person who is not aware of which side the laser will be radiated. N/A Trauma to mental nerve ( following genioplasty ). Intervention 1: Intervention group: Photo-biomodulation therapy will be performed immediately post surgery and 4-6 weeks (twice weekly). Intervention 2: Control group: On the control side, the laser probe will be turned off and will be placed on the designated area. Yes - There is a plan to make this available What will be shared: The data of all of the main variables of the split mouth designed research can be shared. When: 6 months post publication the data may be released. To whom: Data will be shared with all researchers. Conditions: Correct citation of the shared data and the name of all researchers in the future research using the data . Where to obtain: Dr Parsa Behnia Cell phone : 09122979748 Address : No.3 , 21 St , Velenjak , Tehran , Iran 1985878354 parsabehnia1@gmail.com How to obtain: Sending a legal email. Comments:
public Parsa Behnia
No. 3, 21 St , Velenjak
Tehran Iran (Islamic Republic of) 1985838754 +98 21 2242 6454 parsabehnia1@gmail.com Artesh University of Medical Sciences scientific Parsa Behnia
No. 3, 21 St , Velenjak
Tehran Iran (Islamic Republic of) 1985838754 +98 21 2242 6454 parsabehnia1@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) The patient who are candidate for genioplasty 18 years no limit Both Patients who have a history of trauma in the mandible area, especially in the chin area They were previously subjected to similar orthognathic surgery (SSO or Genioplasty). Obvious nerve damage occurs during surgery or the nerve is not identified during surgery. Patients who use psychiatric drugs. People who do not want to participate in the study. Nerve damage has occurred in the past for other reasons. Rehabilitation Rehabilitation Intervention group: Photo-biomodulation therapy will be performed immediately post surgery and 4-6 weeks (twice weekly). Control group: On the control side, the laser probe will be turned off and will be placed on the designated area. To asses post trauma (genioplasty) neurosensory recovery of mental nerve. Timepoint: 1-14-28-56 days post surgery by a clinician unaware of laser therapy. Method of measurement: To asses neurosensory recovery , five subjective and objective tests will be used included Visual Analog Scales (VAS) for general sensitivity, directional discrimination, two point discrimination, pain discrimination and thermal discrimination. Artesh University of Medical Sciences Approved 2023-05-15 Ethics committee of AJA University of Medical Sciences No. 3, 21 St, Velenjak Ave Tehran Tehran Iran (Islamic Republic of)