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IRCT20191127045516N2 IRCT 2020-12-15 Kermanshah University of Medical Sciences Comparison of the effectiveness of ketorolac injection into the masseter and medial pterygoid muscles in preventing the post-operative complications after mandibular third molar sugrery Comparison of the effectiveness of ketorolac injection into the masseter and medial pterygoid muscles in preventing the post-operative complications after mandibular third molar sugrery 2020-11-10 anticipated 84 Complete https://irct.ir/trial/51968 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: patients who have bilateral surgery have at least 15-days interval between each surgery and are admitted to study for only one surgery, Randomization description: Based on the random allocation law,Random numbers are generated using Excel software by a statistician.to do this,three-digit codes are generated 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, Blinding description: participants and outcome assessor are blinded in this study.as the ketorolac injection is done after the anesthesia,patient will not know the exact location of the injection(masseter or internal pterygoid muscle)and will not be informed.also the outcome assessor will not be informed which muscle was injected. 2 Condition 1: severity of pain. Condition 2: Trismus. Condition 3: swelling. Condition 4: paresthesia. Intervention 1: Intervention group 1: injection of 30 mg ampoule of Ketorolac Tromethamine in to the masseter muscle immediately after anesthesia injection. Intervention 2: Intervention group 2: injection of 30 mg ampoule of Ketorolac Tromethamine in to the internal pterygoid 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 Hadis Yari
The school of Dentistry, shariati St.
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 h.yari7493@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 30 mg ampoule of Ketorolac Tromethamine in to the masseter muscle immediately after anesthesia injection. Intervention group 2: injection of 30 mg ampoule of Ketorolac Tromethamine in to the internal pterygoid 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). Number of analgesics taken. Timepoint: 2 and 7 days after surgery. Method of measurement: number(0-100). 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). Kermanshah University of Medical Sciences Approved 2020-09-12 Ethics Committee of Kermanshah University of Medical Sciences Ethics Committee, Department of Research and Technology, Central Building, Shahid Beheshti Boulevard, Kermanshah kermanshah Kermanshah Iran (Islamic Republic of)