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IRCT20200123046230N1 IRCT 2020-02-22 Faculty of Dentistry, Islamic Azad University of Medical Sciences Evaluation of the Effect of Low-level Laser Therapy on the Neurosensory Disturbances Following Inferior Alveolar Nerve Lateralization Surgery: A Randomized Clinical Trial Evaluation of the Effect of Low-level Laser Therapy on the Neurosensory Disturbances Following Inferior Alveolar Nerve Lateralization Surgery: A Randomized Clinical Trial 2020-02-20 anticipated 20 Complete https://irct.ir/trial/45621 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization is performed with the coin toss for each participant and receives one side based on the laser coin toss, Blinding description: After obtaining consent from patients, randomly assigned to the case group (low power laser) and control group (no laser irradiation) for each patient The device is switched off and the patient assumes that both sides are laser treated The researcher is also unaware of the laser being irradiated and the laser treatment process is performed by the technician. N/A Inferior alveolar nerve neurosensory disturbance. Intervention 1: Intervention group: Surgery will be performed by one of the experienced professors with the same standard protocol and materials. After surgery, the intervention group was treated with laser therapy with a 0.3 watt diode laser and 6 joule power (InGaAlP; wavelength 660nm; Thor DD2 Control Unit, Thor, London, UK) for 8 sessions at 72 intervals. It will be placed in the oral alveolar nerve pathway orally for 20 seconds per square centimeter per session. Intervention 2: Control group: Surgery will be performed by one of the experienced professors with the same standard protocol and materials. After surgery, the control group is exposed to placebo laser irradiation with a 0.3 watt laser diode and 6 joules of power (InGaAlP; wavelength 660nm; Thor DD2 Control Unit, Thor, London, UK ) In 8 sessions at 72 hours intervals for 20 seconds per square centimeter, the inferior alveolar nerve pathway will be inhaled orally but the device will be switched off and the laser will not be illuminated. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Arash Azaripour Esfahani
No. 112 , Hodhod building 1 , North Navab Highway
Tehran Iran (Islamic Republic of) 1319813719 +98 21 6638 4856 arashazaripour@gmail.com Faculty of Dentistry, Islamic Azad University of Medical Sciences scientific Arash azaripour Esfahani
No. 112 , Hodhod Building 1 , North Navab Highway
Tehran Iran (Islamic Republic of) 1319813719 +98 21 6638 4856 arashazaripour@gmail.com Faculty of Dentistry, Islamic Azad University of Medical Sciences Iran (Islamic Republic of) Patients Applicant for Dental Implant Therapy on Both Posterior Mandible with Insufficient Bone Height who candidates for inferior alveolar nerve lateralization surgery 20 years no limit Both History of facial fractures History of long term headache Psychological disorders Neurologic disorders Diabetes History of taking anti epileptic drugs Clear nerve damage during surgery Pregnancy G50.8 Other disorders of trigeminal nerve Treatment - Devices Placebo Intervention group: Surgery will be performed by one of the experienced professors with the same standard protocol and materials. After surgery, the intervention group was treated with laser therapy with a 0.3 watt diode laser and 6 joule power (InGaAlP; wavelength 660nm; Thor DD2 Control Unit, Thor, London, UK) for 8 sessions at 72 intervals. It will be placed in the oral alveolar nerve pathway orally for 20 seconds per square centimeter per session. Control group: Surgery will be performed by one of the experienced professors with the same standard protocol and materials. After surgery, the control group is exposed to placebo laser irradiation with a 0.3 watt laser diode and 6 joules of power (InGaAlP; wavelength 660nm; Thor DD2 Control Unit, Thor, London, UK ) In 8 sessions at 72 hours intervals for 20 seconds per square centimeter, the inferior alveolar nerve pathway will be inhaled orally but the device will be switched off and the laser will not be illuminated Sensory function of the inferior alveolar nerve. Timepoint: Before surgery and 1, 3 and 6 months after surgery. Method of measurement: Visual Analogue Scale. Faculty of Dentistry, Islamic Azad University of Medical Sciences Approved 2018-05-27 Ethics committee of Tehran Azad University of Medical Sciences - Faculty of Dentistry No. 112 , Hodhod 1 building , North navab highway Tehran Tehran Iran (Islamic Republic of)