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IRCT20230517058214N1 IRCT 2023-06-19 Mashhad University of Medical Sciences The Effect of Bromelain on Pain, Swelling and Trismus after Orthognathic Surgery The Effect of Bromelain on Pain, Swelling and Trismus after Surgery in Orthognathic Patients 2023-07-23 anticipated 20 Complete https://irct.ir/trial/70169 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Since the two groups are supposed to have the same sample size, the block randomization method will be used in this study. Random block units will usually be used in order to balance the number of samples allocated to each study group. The size of the blocks will be chosen randomly, and each block contains an equal number of each group. The way to make the random sequence will be by the computer software "Random Allocation Software". Concealment of random allocation in sealed envelopes with random sequence will be done by a person who is not aware of the study process, Blinding description: Participants, surgeons, orthodontists, and data and outcome analysts will not know how the groups were assigned. Placebo and bromelain capsules with a completely similar appearance are prepared by the pharmacist and provided to the researchers in plastic covers with the number specified by the pharmacist. 3 Class III with maxilla deficiency and mandible prognathism. Intervention 1: Intervention group: Taking bromelain 200 mg powder inside the capsule three times a day for 8 days. Intervention 2: Control group: Taking the powder inside the placebo capsule three times a day for 8 days. Yes - There is a plan to make this available What will be shared: All collected data would be shared for all researchers after the participants were unidentified. When: The access to data will be started 6 months after publication. To whom: The data would only be available for people working in academic institutions. Conditions: It is allowed to use the data for meta-analysis and systematic reviews. Where to obtain: The data can be obtained via email, from the corresponding researcher (Dr Seyedeh Maryam Omidkhoda). E-mail: omidkhodam@mums.ac.ir How to obtain: The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission. Comments:
public Seyedeh Maryam Omidkhoda
Mashhad Dental School, Vakil Abad Blvd.
Mashhad Iran (Islamic Republic of) 9177948959 +98 917 112 8147 omidkhodam@mums.ac.ir Mashhad University of Medical Sciences scientific Sahand Samiee Rad
Mashhad Dental School, Vakil Abad Blvd.
Mashhad Iran (Islamic Republic of) 9177948959 +98 912 813 7859 samieerads@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of the Disease by an Orthodontist and Surgery by a Maxillofacial Surgeon Willingness to Cooperate and Sign the Informed Consent Form after being fully informed about the objectives and method of conducting the study Not taking supplements for at least one month before 20 years 50 years Both Suffering from chronic diseases such as diabetes mellitus, kidney failure, liver disorder and cancer Suffering from other autoimmune and inflammatory diseases Suffering from hormonal disorders, thyroid disorders Alcohol consumption and hookah use Smoking and being exposed to secondhand smoke chronically Unwillingness to participate in the study K07.1 Anomalies of jaw-cranial base relationship Treatment - Drugs Placebo Intervention group: Taking bromelain 200 mg powder inside the capsule three times a day for 8 days Control group: Taking the powder inside the placebo capsule three times a day for 8 days Evaluation of swelling before and after intervention. Timepoint: Days 1, 7, 30 after surgery will be compared with these measurements before surgery and immediately after surgery. Method of measurement: to evaluate the swelling of the total length of the considered lines in the anatomical areas of the face will be used. 2. Assessment of pain before and after intervention. Timepoint: Days 1, 7, 30 after surgery will be compared with these measurements before surgery and immediately after surgery. Method of measurement: Visual analogue scale will be used in this evaluation. Evaluation of mouth opening before and after the intervention. Timepoint: Days 1, 7, 30 after surgery will be compared with these measurements before surgery and immediately after surgery. Method of measurement: with a ruler from the incisal edge of the centrals in the state of maximum mouth opening. Mashhad University of Medical Sciences Approved 2023-03-11 Ethics committee of Mashhad University of Medical Sciences Ghoreishi Building, Daneshgah avenue. Mashhad Razavi Khorasan Iran (Islamic Republic of)