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IRCT20191127045516N5 IRCT 2021-10-11 Kermanshah University of Medical Sciences Comparison of the effectiveness of Betamethasone LA injection into the masseter and medial pterygoid muscles in preventing the post-operative complications after mandibular third molar surgery Comparison of the effectiveness of Betamethasone LA injection into the masseter and medial pterygoid muscles in preventing the post-operative complications after mandibular third molar surgery 2021-10-09 anticipated 90 Complete https://irct.ir/trial/58712 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random numbers are generated using Excel software by a statistician to do this. Four-digit codes are generated. A four digit code is allocated to each patient and the last digit on the right indicates the patient group.if the number obtained is odd(1,3,5,7,9),the patient is in the internal pterygoid muscle injection group and if the number is even(0,2,4,6,8),the patient is in the masseter muscle injection group Each of the generated codes is kept separately inside the envelope and the receptionist gives one of these envelopes to the patient before entering the doctor's room. Accordingly, the next patient code is not predictable. Based on the patient's code, the physician determines which treatments to implement, Only the physician who implements the intervention knows the code allocated to the patient, which after evaluating the outcome, based on thepatient's name, the information collected will be related to the assigned codes, Blinding description: As the injection is done in each masseter and internal pterygoid muscle its not possible to blind the patient. but the person who is in charge of assessing the outcome , is uninformed about the method of allocation of patients to groups . Therefore only outcome assessor is blinded in this study. 2 Condition 1: severity of pain. Condition 2: Trismus. Condition 3: swelling. Condition 4: paresthesia. Intervention 1: Intervention group:1: injection of 1mL ampoule of Betamethasone LA in to the internal pterygoid muscle immediately after anesthesia injection. Intervention 2: Intervention group 2: injection of 1mL ampoule of Betamethasone LA in to the masseter muscle immediately after anesthesia injection. 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 There is no further information
public Hamed Nazari
The school of Dentistry, shariati St.
kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 Nazari.hamed67@gmail.com Kermanshah University of Medical Sciences scientific Hamed Nazari
School of Dentistry, Shariati St.
kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 Nazari.hamed67@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) ASA I or II health status. presence of a impacted mandibular third molar confirmed by a panoramic image absence of the mandibular third molar infection and pericoronitis The patient is ready to take part in the study and sign the testimonial 18 years 40 years Both History of underlying diseases affecting the wound healing process like systemic diseases(diabetes,high blood pressure,gastrointestinal system diseases,kidney disorders,heart and lung diseases) current consumption of drugs,alcohol,opiums(consumption of any of these substances during the last month) smoking(someone who has smoked at least two cigarettes a day during the last month) recent consumption of anti- inflammatory drugs and antibiotics pregnant women any allergies or Hypersensitivities to the drugs used in this study G89.1 G71.8 R22.9 R20 Acute pain, not elsewhere classified Other primary disorders of muscles Localized swelling, mass and lump, unspecified Disturbances of skin sensation Prevention Prevention Intervention group:1: injection of 1mL ampoule of Betamethasone LA in to the internal pterygoid muscle immediately after anesthesia injection. Intervention group 2: injection of 1mL ampoule of Betamethasone LA in to the masseter muscle immediately after anesthesia injection. Severity of pain. Timepoint: before surgery,2 and 7 days later. Method of measurement: Visual Analogue Scale(VAS). Swelling. Timepoint: 2 and 7 days after surgery. Method of measurement: Visual Analogue Scale(VAS). General satisfaction. Timepoint: 2 and 7 days after surgery. Method of measurement: Visual Analogue Scale(VAS). Trismus. Timepoint: 2 and 7 days after surgery. Method of measurement: Restrictions on opening the mouth(mild,moderate,severe). Paresthesia. Timepoint: 2 and 7 days after surgery. Method of measurement: yes/no. Maximum opening of the mouth. Timepoint: before surgery,2 and 7 days later. Method of measurement: by a ruler(0-50 millimetre). Difficulty of the surgery. Timepoint: Before surgery. Method of measurement: according to panoramic radiograph based on spatial direction,depth and ramus relationship(easy,moderate,difficult). Number of analgesics taken. Timepoint: 2 and 7 days after surgery. Method of measurement: number(0-100). Kermanshah University of Medical Sciences Approved 2021-09-11 کمیته اخلاق دانشگاه علوم پزشکی کرمانشاه Ethics Committee, Department of Research and Technology, Central Building, Shahid Beheshti Boulevard, Kermanshah kermanshah Kermanshah Iran (Islamic Republic of)