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IRCT20181204041849N1 IRCT 2019-02-10 Bojnourd University of Medical Sciences Effect of dexamethasone injection on reducing complications due to impacted wisdom tooth surgery Comparison of efficacy of pre-operative dexamethasone injection into masseter muscle versus gluteus major muscle on reducing complications due to impacted mandibular third molar surgery 2019-01-01 anticipated 22 Complete https://irct.ir/trial/35879 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Individual randomization will be done through lottery. On paper sheets with same color and concealed content, numbers from 0 through 9 will be put and for every patient who is studied, a number will be drawn to determine on which muscle and which side the first injection must be done. For even numbers, the injection is performed on Masseter, conversely, in case of odd numbers the patient will be injected in Gluteus. To decide on which side the surgery must be done, on two same-colored sheets of paper the words "left" and "right" will be put then a one paper is drawn. To equalize the groups in size, there will be no more draws after the quorum for subject who have been given the first injection on the same muscle is present and the rest will be injected in the other muscle at first; in other words, 11 subjects will take the first injection in Masseter and the other 11 will get the initial injection in Gluteus. furthermore, 11 patients will undergo surgery on their right side at first, whereas, the other 11 will be operated on their left side at first, Blinding description: Information will be provided to the analyzer in the form of muscle numbers 1 & 2. 3 Impacted mandibular third molar surgery. Intervention 1: Intervention group: injection of Dexamethasone 8 mg into the Masseter muscle 1-2 hours before surgery & after inferior alveolar nerve block injection for one side surgery. Intervention 2: Intervention group: injection of Dexamethasone 8mg into the gluteus major muscle 1-2 hours before surgery for the other side of the same person. Yes - There is a plan to make this available What will be shared: Information about the main consequence, have the ability to share, after unidentifiable people. When: Start the access period 6 months after printing the results To whom: Researchers working in academic & scientific institutions Conditions: The use of data in order to complete scientific information and research is permissible and sending a request for access to data has not a specific condition. Where to obtain: 1.North Khorasan University of Medical Sciences, dental College 2. s.etemadzade@gmail.com How to obtain: After sending the email, it will be answered for a few days. Comments:
public Sepideh Etemadzadeh
Shahriar St., North Khorasan University of Medical Sciences
Bojnord Iran (Islamic Republic of) 9417694735 +98 58 3624 5629 s.etemadzade@gmail.com Bojnourd University of Medical Sciences scientific Sepideh Etemadzadeh
Shahriar St., North Khorasan University of Medical Sciences
Bojnord Iran (Islamic Republic of) 9417694735 +98 58 3624 5629 s.etemadzade@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) People who have impacted mandibular wisdom tooth in both sides with same difficulty. People who don`t have pericoronitis & infection. 15 years 35 years Both Pregnant women People who have uncontrolled systemic disease. People who have sensitivity to the drugs that are being used in the study. Use of drugs that interfere with dexamethasone. Prevention Prevention Intervention group: injection of Dexamethasone 8 mg into the Masseter muscle 1-2 hours before surgery & after inferior alveolar nerve block injection for one side surgery. Intervention group: injection of Dexamethasone 8mg into the gluteus major muscle 1-2 hours before surgery for the other side of the same person. Edema. Timepoint: Before the surgery, second & seventh day after surgery. Method of measurement: Swelling will be measured by a flexible ruler & the distance between the facial landmarks (tragus-pogonium, tragus-commissur of the lip, angle of mandible-outer canthus of eye) in millimeters. Pain. Timepoint: Surgical day, Day 1, Day 3 and Seventh day after surgery. Method of measurement: Patients score 10-0 according to the Standard Visual Analog Scale. Trismus. Timepoint: Before the surgery, second & seventh day after surgery. Method of measurement: Measure the distance between the edges of the upper and lower central incisors by a graded ruler, when the patient opens the mouth to the extent possible. Bojnourd University of Medical Sciences Approved 2018-12-03 National commitee of North Khorasan University of Medical Sciences Shahriar Ave., North Khorasan University of Medical Sciences Bojnord North Khorasan Iran (Islamic Republic of)