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IRCT20230517058216N1 IRCT 2023-07-27 Yazd University of Medical Sciences Comparison Efficacy of platelet-rich fibrin membrane and melatonin on sensory recovery following mandibular fracture Comparison Efficacy of platelet-rich fibrin membrane and melatonin on sensory recovery following mandibular fracture: a double-blind randomized trial 2022-12-22 anticipated 45 Complete https://irct.ir/trial/70987 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into three groups according to the permutation block randomization method. Based on the permutation blocks method, 5 blocks of 9 blocks are considered for randomizing the samples in three groups. The randomization method of permutation blocks is based on random blocks with the same size, and random allocation 1 software is used to create random blocks. Based on the output of the software, based on each block of size 9, a number from 1 to 9 that represents the block number is randomly selected and then according to the assigned groups in each block, randomization of the samples in the order of entering The study is based on the specified intervention, Blinding description: This study is double-blind, and the examiner who performs the post-operative examinations and completes the checklist and the patient are blind to the type of intervention. For all patients, the study process, including how to prepare platelet-rich fibrin from the patient's blood sample in the first group, and the use of melatonin in the second group, are described. However, which group the patient will be placed in is determined during the sampling process and based on randomization. 3 Lower lip and chin paresthesia due to mandibular fracture. Intervention 1: Intervention group: In group 1, after exposing the fracture area, in cases of involvement of the lower alveolar canal, PRF prepared from the patient's blood is placed inside the bone and on the canal, and then bone reduction and fixation are performed by miniplates and mono-cortical screws. In cases of exposure of the mental nerve, the fibrin membrane is placed directly on the nerve in the exit area of ​​the foramen and is supported by an absorbable collagen membrane and absorbable suture. Intervention 2: Intervention group: In group 2, 10 mg melatonin capsules (Galinos-Iran) were given to the patients the night before surgery and then one capsule every night until 21 days after surgery. Patients who undergo IMF after surgery dissolve the contents of the capsule in a glass of water and drink it. Reduction and fixation of fracture lines will be done as in group 1. Intervention 3: Control group: In group 3, reduction and fixation of fracture lines will be performed as the control group. Yes - There is a plan to make this available What will be shared: All data can be shared transparently. When: The access period starts 6 months after the results are published. To whom: All researchers and practitioners in related industry to the study title. Conditions: Data use or analysis is permitted with the permission of the research investigators Where to obtain: Mohammad Goodarzi E-mail :m.goodarzi.omfs@gmail.com How to obtain: By sending an email to the researcher, the documentation plan will be sent to them within a month. Comments:
public Mohammad Goodarzi
Department of Maxillofacial Surgery, Shahid Rahnamon Hospital, Farrokhi Street, Yazd
Yazd Iran (Islamic Republic of) 8913814396 +98 35 3312 2002 m.goodarzi.omfs@gmail.com Yazd University of Medical Sciences scientific Alireza Navab Azam
Department of Maxillofacial Surgery, Shahid Rahnamon Hospital, Farrokhi Street, Yazd
Yazd Iran (Islamic Republic of) 8913814396 +98 35 3312 2002 alirezanavabazam266@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Patients whit no history of systemic diseases such as diabetes, kidney and liver problems Patients with no history of sensitivity to melatonin Patients who have informed consent to participate in the study Patients who have no history of previous mandibular surgery and nerve damage Patients with minimally displaced fractures that require open treatment of the mandible Patients with a level of GCS of 15, who are fully awake for examinations 18 years 60 years Both Patients who have dissected nerve fibers at the fracture site Patients who have soft tissue injuries in the lower lip and chin area. Patients with mental retardation and psychotic disorders who do not cooperate for examinations Patients with blood and coagulation disorders R20 Disturbances of skin sensation Treatment - Drugs Treatment - Drugs Treatment - Surgery Intervention group: In group 1, after exposing the fracture area, in cases of involvement of the lower alveolar canal, PRF prepared from the patient's blood is placed inside the bone and on the canal, and then bone reduction and fixation are performed by miniplates and mono-cortical screws. In cases of exposure of the mental nerve, the fibrin membrane is placed directly on the nerve in the exit area of ​​the foramen and is supported by an absorbable collagen membrane and absorbable suture. Intervention group: In group 2, 10 mg melatonin capsules (Galinos-Iran) were given to the patients the night before surgery and then one capsule every night until 21 days after surgery. Patients who undergo IMF after surgery dissolve the contents of the capsule in a glass of water and drink it. Reduction and fixation of fracture lines will be done as in group 1 Control group: In group 3, reduction and fixation of fracture lines will be performed as the control group. Improving the amount of lower lip paresthesia caused by mandibular fracture. Timepoint: One week, one month and three months. Method of measurement: Two-point discrimination, brush direction detection and self-expression (Visual Analogue Scale) tests. Yazd University of Medical Sciences Approved 2022-12-12 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Central Organization of Shahid Sadoughi University of Medical Sciences and Health Services, Shahid Bahonar square, Yazd Yazd Yazd Iran (Islamic Republic of)