Comparison Efficacy of platelet-rich fibrin membrane and melatonin on sensory recovery following mandibular fracture: a double-blind randomized trial

Determining and comparing the effect of platelet-rich fibrin membrane and melatonin on nerve recovery following mandibular fractures

The clinical trial has a control group, with factorial groups, double-blind, randomized, phase 3 on 45 patients, and permutation blocks were used for randomization.

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 . 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. In group 2, 10 mg melatonin capsules were given to the patients the night before surgery and then one capsule every night until 21 days after surgery. Reduction and fixation of fracture lines will be done as in group 1. In group 3, reduction and fixation of fracture lines will be performed as the control group. In this study the examiner and the patient are blind to the type of intervention.

Entry requirements: Patients with minimal displacement Fractures that require open mandibular fracture treatment Patients with no history of sensitivity to melatonin Non-entry conditions: Patients who have severed nerve fibers at the fracture site Patients who have soft tissue injuries in the lower lip and chin area.

In group 1, patients are treated with platelet-rich fibrin membrane. In group 2, patients are treated with melatonin. In group 3 (control), reduction and fixation of fracture lines will be performed.

Improving the para-esthesia of the lower lip and chin caused by mandibular fracture, using platelet-rich fibrin membrane or melatonin

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

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.

All data can be shared transparently.

The access period starts 6 months after the results are published.

All researchers and practitioners in related industry to the study title.

Data use or analysis is permitted with the permission of the research investigators

Mohammad Goodarzi E-mail :m.goodarzi.omfs@gmail.com

By sending an email to the researcher, the documentation plan will be sent to them within a month.