]>
IRCT20120531009926N9 IRCT 2020-10-19 Hamedan University of Medical Sciences Effect of ِِDiode Laser 940 nm in Decreasing of Oropharyngeal Pain after Orthognathic Surgery Determination of the Effectiveness of ِِDiode Laser 940 nm in Decreasing of Oropharyngeal Pain after Bimaxillary Orthognathic Surgery. 2019-05-10 anticipated 40 Complete https://irct.ir/trial/39218 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each patient as a unit of randomization will be allocated in group A or B through four blocks. Concealment will be done by sealed envelope. The sequence of blocks will be determined with software. N/A Condition 1: Pain in the oropharynx after simultaneous surgery of the two jaws. Condition 2: Pain in the oropharynx after simultaneous surgery of the two jaws. Intervention 1: Patients in the intervention group will be irradiated in the oropharyngeal region with 940 laser (Biolase, USA) immediately after surgery and before removal of the nasopharyngeal tube. Irradiation will be done continuously on all regions of oropharyngeal walls i.e posterior wall, lateral walls and posterior of the tongue. Irradiation will be fulfilled with a regular head and without contact to skin or mucosa. Output power is 100 w and spot size is 0.5 cm2. Irradiation time in each region is 20 s and power density is 0.2 w/ cm2. Intervention 2: Control group: In patients in the control group, after laser surgery of both jaws, no 940 diode laser radiation (Biolase, USA) is performed in the oropharynx. Yes - There is a plan to make this available What will be shared: In the intervention group, a 940 nm diode laser is applied to the oropharynx after simultaneous surgery, and the pain in the oropharynx is measured after the operation. When: In the first to fifth days after surgery To whom: Doctors, assistants and students Conditions: Merely the development of science and research Where to obtain: surgery room How to obtain: 1- Patient selection 2- Treatment plan 3- Anesthesia process 4- Surgery 5- Laser irradiation 6. Pain measurement Comments:
public Mohammad Reza Jamalpour
pazhohesh street
Hamَdan Iran (Islamic Republic of) 95166852369 +98 81 3832 3264 jamalpour1972@gmail.com Hamedan University of Medical Sciences scientific Mohammad Reza Jamalpour
Pazhohesh street
Hamadan Iran (Islamic Republic of) 65166852369 +98 81 3832 3264 jamalpour1972@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) All patients who are candidates for bimaxillary orthognathic surgery. no limit no limit Both History of pain in the orofacial region before surgery Taking analgesic, sedative, or corticosteroid before surgery If surgery lasts more than 4 hours and less than 3 hours If the intubation process repeats If an anesthetic complication occurs If a surgical complication occurs Code R07.0 Code R07.0 ICD-10-CM Diagnosis Code R07.0: Pain in throat ICD-10-CM Diagnosis Code R07.0: Pain in throat Treatment - Surgery Treatment - Surgery Patients in the intervention group will be irradiated in the oropharyngeal region with 940 laser (Biolase, USA) immediately after surgery and before removal of the nasopharyngeal tube. Irradiation will be done continuously on all regions of oropharyngeal walls i.e posterior wall, lateral walls and posterior of the tongue. Irradiation will be fulfilled with a regular head and without contact to skin or mucosa. Output power is 100 w and spot size is 0.5 cm2. Irradiation time in each region is 20 s and power density is 0.2 w/ cm2. Control group: In patients in the control group, after laser surgery of both jaws, no 940 diode laser radiation (Biolase, USA) is performed in the oropharynx. Oropharyngeal pain. Timepoint: ّFirst, second, third, fourth and fifth days after surgery. Method of measurement: Visual Analogue Scale. Pain in maxillary and/or mandibular regions. Timepoint: ّFirst, second, third, fourth and fifth days after surgery. Method of measurement: Visual Analogue Scale. Pain during swallowing. Timepoint: ّFirst, second, third, fourth and fifth days after surgery. Method of measurement: Visual Analogue Scale. Stridor. Timepoint: ّFirst, second, third, fourth and fifth days after surgery. Method of measurement: Listening. ACTRN1261600143646op " for ANZCTR WHO International Clinical Trials Registry Hamedan University of Medical Sciences Approved 2019-05-04 Ethics Committee of Hamadan Medical Sciences University Oral and Maxillofacial Surgery Department- Hamadan Medical Sciences University- Shahid Fahmideh Blv- Hamadan Hamadan Hamadan Iran (Islamic Republic of)