]>
IRCT20230131057290N1 IRCT 2023-08-14 Shiraz University of Medical Sciences Comparison of the effect of bromoline drug on pain and trismus after dental surgery Comparison of the effect of two drugs bromelain and ibuprofen in combination with acetaminophen and corticosteroid on pain and trismus after mandibular third molar surgery 2023-08-23 anticipated 80 Complete https://irct.ir/trial/71937 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize in this study, simple randomization method will be used. Randomization will be done using a sealed envelope containing a bead. If there is a white bead in the envelope, the patient will be in the intervention group, and if the envelope contains a red bead, he will be placed in the control group, Blinding description: This study will be a double-blind study. The evaluated drugs are placed in the same packages and will be provided to the patients along with the prescription instructions. Patients receive the medicine in sealed envelopes with black cover that are coded (A and B). Study drugs are administered to patients by an independent surgeon. Therefore, neither the patients nor the researchers will be aware of the type of drug given to the patients. 1-2 .. Intervention 1: Intervention group: 500 mg bromelain drug (Permon Amin Pharmaceutical Company) along with acetaminophen 325 mg every 8 hours (three times a day) and corticosteroids including dexamethasone 8 mg by intramuscular injection in one session immediately after surgery. Intervention 2: Control group: Ibuprofen drug 200 mg (Hakim Pharmaceutical Company) along with acetaminophen 325 mg every 8 hours (three times a day) and corticosteroid including dexamethasone 8 mg as intramuscular injection in one time immediately after surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is The data will remain confidential with the researcher and will only be used to carry out this research project.
public Ilnaz Ghanbari
Qomabad St. Qasrdasht - School of Dentistry
shiraz Iran (Islamic Republic of) 1587871956 +98 71 3628 0112 ilnazaghanbari@sums.ac.ir Shiraz University of Medical Sciences scientific Ilnaz Ghanbari
Qomabad Qasrdasht St. - School of Dentistry
shiraz Iran (Islamic Republic of) 1587871956 +98 71 3628 0112 ilnazaghanbari@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Needing mandibular third molar surgery Age between 17-35 years Semi-embedded mesiangular mandibular third molar teeth 17 years 35 years Both Patients who have taken painkillers or other drugs within 24 hours before surgery. have a history of addiction to drugs or painkillers Patients who are pregnant or breastfeeding, or have a known sensitivity to analgesics, common non-steroidal anti-inflammatories or cyclooxygenase-2 inhibitors. Those who have a history of nasal polyps, bronchospasm or angioedema caused by non-steroidal anti-inflammatories. Patients who were not able to take medicine orally . . Treatment - Drugs Treatment - Drugs Intervention group: 500 mg bromelain drug (Permon Amin Pharmaceutical Company) along with acetaminophen 325 mg every 8 hours (three times a day) and corticosteroids including dexamethasone 8 mg by intramuscular injection in one session immediately after surgery. Control group: Ibuprofen drug 200 mg (Hakim Pharmaceutical Company) along with acetaminophen 325 mg every 8 hours (three times a day) and corticosteroid including dexamethasone 8 mg as intramuscular injection in one time immediately after surgery. Pain. Timepoint: 1, 3 and 7 days after surgery. Method of measurement: A visual analogue scale (VAS), with 10 points, will be evaluated from 0 for "no pain" to 10 for "worst possible pain". Trismus. Timepoint: 1, 3 and 7 days after surgery. Method of measurement: The degree of trismus is also measured by measuring the inter-incisal distance using a measuring caliper and the results are reported with an accuracy of 0.01 mm. Shiraz University of Medical Sciences Approved 2023-07-05 Ethics Committee of Shiraz University of Medical Sciences Zand St., Central Building of Shiraz University of Medical Sciences shiraz Fars Iran (Islamic Republic of)