]>
IRCT20191014045101N1 IRCT 2020-01-19 Yazd University of Medical Sciences Comparative Assessment of the Effect of Ibuprofen and ketorolac on Edema Trismus and Pain after lower Third Molar Surgery Comparative Assessment of the Effect of Ibuprofen and ketorolac on Edema Trismus and Pain after lower Third Molar Surgery 2020-01-25 anticipated 20 Complete https://irct.ir/trial/43505 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Simple Randomization Using Random Allocation Software, Individual Randomization Unit Random Allocation Software Randomization Tool, How to Build Random Sequence Randomization Software, Explanation of Drug Coded by Dr Pharmacist, and When giving the medicine to the patient, the pharmacist is asked what medication code to give to the patient, Blinding description: The two types of drugs studied include ibuprofen 200 mg and ketorolac 10 mg (Caspian Pharmaceuticals) in capsules apparently similar to those prepared by the pharmacist so that neither the surgeon, the student, nor the patient were aware of the contents of each package. Randomly, one of the packets that is coded by the pharmacist will be given to the patient. 2 Mandibular Impacted Teeth Surgery. Intervention 1: Intervention group: Ibuprofen Consumer: Ibuprofen 200 mg (Caspian Pharmaceutical Company) Two medicines in capsules that are apparently similarly prepared by the pharmacist so that neither the surgeon nor the student nor the patient The contents of each packet will be randomly assigned to one of the packets coded by the pharmacist. Patients will be advised to take one of these capsules when the pain begins after surgery. Afterwards, take the capsule every 6 hours for two days. Intervention 2: Intervention group: Ketorolac Consumer: Ketorolac 10 mg (Caspian Pharmaceutical Company) Two medicines in capsules that are apparently similarly prepared by the pharmacist so that neither the surgeon nor the student nor the patient The contents of each packet will be randomly assigned to one of the packets coded by the pharmacist. Patients will be advised to take one of these capsules when the pain begins after surgery. Afterwards, take the capsule every 6 hours for two days. 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 DR.MOSTAFA GAVAHI
YAZD,DAHE FAJR BLVD,Faculty of Dentistry
YAZD Iran (Islamic Republic of) 8914881167 +98 35 3827 9615 mgdds@ssu.ac.ir Yazd University of Medical Sciences scientific MOSTAFA GAVAHI
YAZD,Dahe fajr Blvd
YAZD Iran (Islamic Republic of) 8914881167 009835362558813 pajoheshdentyazd@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) 1) Age between 16 and 35 years 2) Any systemic disease of any body organ such as anemia, epilepsy, diabetes, hypertension, hyperthyroidism, osteoporosis or digestive disease, addicts and alcoholics who put surgery at risk Either inhibits the administration of the drug or makes it difficult to repair the surgical area 3) The presence of any localized lesions including odontogenic cysts or tumors (dependent or non-dependent on the third molar) trauma to the area or any signs of inflammation (pericoronitis) or Infection 4) No use of any drug, especially anti-inflammatory drugs 3 days before surgery 5) No history of NSAID sensitivity (ibuprofen or ketorolac) 6) Lack of any conditions that may include impaired immunity (including one year's history of chemotherapy, use of immunosuppressants) 16 years 35 years Both 1) Patients who have only one tooth extracted and who have not been referred to the opposite tooth for surgery 2) Patients who have not taken their medication as prescribed 3) Patient non-cooperation Treatment - Drugs Treatment - Drugs Intervention group: Ibuprofen Consumer: Ibuprofen 200 mg (Caspian Pharmaceutical Company) Two medicines in capsules that are apparently similarly prepared by the pharmacist so that neither the surgeon nor the student nor the patient The contents of each packet will be randomly assigned to one of the packets coded by the pharmacist. Patients will be advised to take one of these capsules when the pain begins after surgery. Afterwards, take the capsule every 6 hours for two days Intervention group: Ketorolac Consumer: Ketorolac 10 mg (Caspian Pharmaceutical Company) Two medicines in capsules that are apparently similarly prepared by the pharmacist so that neither the surgeon nor the student nor the patient The contents of each packet will be randomly assigned to one of the packets coded by the pharmacist. Patients will be advised to take one of these capsules when the pain begins after surgery. Afterwards, take the capsule every 6 hours for two days Edema Trismus and Pain. Timepoint: Before surgery and 2 and 7 days after surgery. Method of measurement: In the post-treatment period, pain ratings will be assessed by reporting pain scores on an 11-point visual Analogue scale by patients at 6, 12, and 24 hours after surgery. Edema assessment is performed by measuring intervals such as the interval between the tip of the chin to the lower edge of the ear fins and the mandibular tooth line before and 2 and 7 days after surgery. Evaluation of mouth opening will be done by measuring the maximal distance between the incisal edges of the anterior teeth before and 2 and7 days after surgery. Yazd University of Medical Sciences Approved 2019-07-27 Ethics committee of Yazd Faculity of DENTISTRY Yazd,dahe fajr Blvd YAZD Yazd Iran (Islamic Republic of)