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IRCT20191127045516N6 IRCT 2022-02-26 Kermanshah University of Medical Sciences comparison of the effect of Ketorolac and Betamethasone injection on post complications of third molar surgery comparison of the effect of Ketorolac and Betamethasone injection on post complications of third molar surgery (A clinical trial) 2022-02-24 anticipated 108 Complete https://irct.ir/trial/62137 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, the randomization block method with classification will be used. The classification will be based on gender and difficulty of surgery. Random sequencing will be performed by a statistical expert using Excel software with RANDOM function and Sort command in each class separately and codes A and B. To prevent the prediction of the last patient group in each block, blocks with different sizes of two, four and six in all classes will be used. Randomization will be considered for 40 patients in each class, Blinding description: Blinding will be done on one level, only the participant. Participants will not be able to identify the type of injectable drug because they will not be informed of the drug group to which they will belong. Patients are grouped through exactly the same envelopes containing the letters A or B. The physician is aware of the relationship between the letters and the drug, but patients are unaware. Patients will be informed about the drugs used in the trial before participating in the study. 2-3 impacted teeth. Intervention 1: Intervention group 1: A single intramuscular injection of 3mg betamethasone LA in 1mL (manufactured by Exir Pharmaceutical Company) in the master muscle immediately after injection of 2% lidocaine anesthesia. Intervention 2: Intervention group 2: A single intramuscular injection of 30 mg in 1 mL of ketorolac (manufactured by Exir Pharmaceutical Company) in the master muscle immediately after injection of 2% lidocaine anesthesia. 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 no more information
public Hamed Nazari
Shariati St.Dentistry School.
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 Nazari.hamed67@gmail.com Kermanshah University of Medical Sciences scientific Hamed Nazari
Shariati St.Dentistry school
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 Nazari.hamed67@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Physical health (ASA I or II) free of infection and pericoronitis. the presence of a third mandibular molars whose occlusion is confirmed by panoramic radiography age18 to 40 years old 18 years 40 years Both Concomitant use of antibiotics and nonsteroidal anti-inflammatory drugs, salicylates, anticoagulants, anticonvulsants, and valprates is due to interaction with the injectable substance (ketorolac). Current use of any of these substances in the past month (drugs, alcohol, opium, smoking) Someone who has smoked at least two cigarettes a day in the past month Difficulty of surgery based on Pell and Gregory classification (Winter classification). allergies to the drugs used in this study Diseases that interfere with wound healing such as systemic diseases such as diabetes, hypertension, gastrointestinal diseases, kidney and lung and heart diseases, pregnancy. K01.1 Impacted teeth Prevention Prevention Intervention group 1: A single intramuscular injection of 3mg betamethasone LA in 1mL (manufactured by Exir Pharmaceutical Company) in the master muscle immediately after injection of 2% lidocaine anesthesia. Intervention group 2: A single intramuscular injection of 30 mg in 1 mL of ketorolac (manufactured by Exir Pharmaceutical Company) in the master muscle immediately after injection of 2% lidocaine anesthesia. Pain severity. Timepoint: second and seventh day after surgery. Method of measurement: visual analogue scale. Swelling. Timepoint: second and seventh day after surgery. Method of measurement: visual analogue scale. Trismus. Timepoint: the second and seventh day after surgery. Method of measurement: Maximum mouth opening limitation less than 35 mm. Surgery difficulty. Timepoint: before the surgery. Method of measurement: Using panoramic radiography based on tooth position angle, depth and position relative to Ramos mandible - Based on panoramic radiographic classification (Pell and Gregory classification, Winter classifocation) -. Patient general satisfaction. Timepoint: the second and seventh day after surgery. Method of measurement: visual analogue scale. Maximum mouth opening. Timepoint: beofre the surgery and second and seventh day after surgery. Method of measurement: interincisal distance between mandibular and maxillary central teeth. Kermanshah University of Medical Sciences Approved 2022-02-08 Research Ethics Committee of Kermanshah University of Medical Sciences SHAHID BEHESHTI Blvd kermanshah Kermanshah Iran (Islamic Republic of)