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IRCT20130812014333N155 IRCT 2020-11-18 Kermanshah University of Medical Sciences Comparison of two ketorolac injection methods on complications after third tooth surgery Comparison of the effectiveness of ketorolac subperiosteal and infiltrate injections into the buccal mucosa in preventing postoperative complications after impacted third molar surgery. 2020-10-06 anticipated 84 Complete https://irct.ir/trial/50539 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The permutation random block is used for randomization. In this way, first, the total sample size and the ratio of sample size in groups are determined. Then, the number of samples will be selected from the table of random numbers of single-digit numbers between 0 and 9. For studies with two groups, the numbers 0-9 are divided into two equal blocks with a probability of assigning an individual to each block is 0.5. Block 4-0 for the first group and block 5-9 for the second treatment can be used. Based on the selected numbers from the table of random numbers and the determination of blocks, it is clear in which group each person who enters the study will be placed, Blinding description: The patient and physician evaluating the outcome will be kept blind to the exact injection site. 2-3 Impacted teeth. Intervention 1: The first intervention group will receive 30 mg of single-dose ketorolac (Alborz Pharmaceutical Company) as a subperiosteal injection immediately after anesthesia injection of the alveolar and lingual nerve blocks. Intervention 2: The second intervention group will receive 30 mg of single-dose ketorolac (Alborz Pharmaceutical Company) as an infusion injection in the buccal mucosa immediately after injection of anesthesia of the alveolar and lingual nerve blocks. Yes - There is a plan to make this available What will be shared: The main outcomes of the study will be shared. When: 3 months To whom: If requested, results will be made available to other academic researchers Conditions: Collected data is confidential and will not be shared with anyone else Where to obtain: Send E-mail to the responsible for the update to get the documentation How to obtain: Documentation will be emailed within a 15-day timeframe Comments:
public Mehrnaz Pourahmadi
School of Dentistry, Shariati St.
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 140dent95mehr@gmail.com Kermanshah University of Medical Sciences scientific Dr. 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) Physical health Presence of an impacted third molar is confirmed by panoramic radiography and is free of infection and pericoronitis No concomitant use of nonsteroidal anti-inflammatory drugs, salicylates, anticoagulants, anticonvulsants, and valprates due to interference with the injectable substance (ketorolac). 18 years 40 months Both Recent use of anti-inflammatory drugs and antibiotics Having underlying diseases such as diabetes, gastrointestinal diseases, etc. Current consumption of drugs, alcohol and opium over the past month Pregnant women K01 Embedded and impacted teeth Treatment - Other Treatment - Other The first intervention group will receive 30 mg of single-dose ketorolac (Alborz Pharmaceutical Company) as a subperiosteal injection immediately after anesthesia injection of the alveolar and lingual nerve blocks. The second intervention group will receive 30 mg of single-dose ketorolac (Alborz Pharmaceutical Company) as an infusion injection in the buccal mucosa immediately after injection of anesthesia of the alveolar and lingual nerve blocks. Pain intensity. Timepoint: Two and 7 days after dental surgery. Method of measurement: Based on visual pain scale. Trismus. Timepoint: Two and 7 days after dental surgery. Method of measurement: Question from the patient (Low, medium, severe). Paresthesia. Timepoint: Two and 7 days after dental surgery. Method of measurement: Question from the patient (Low, medium, severe). Kermanshah University of Medical Sciences Approved 2020-09-12 Ethics committee of Kermanshah University of Medical Sciences Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)