]>
IRCT20200922048799N2 IRCT 2022-01-10 Shahid Beheshti University of Medical Sciences The effect of platelet-rich fibrin on neurosensory recovery of inferior alveolar nerve injury The effect of platelet-rich fibrin on neurosensory recovery of inferior alveolar nerve injury after mandibular body fracture 2022-02-18 anticipated 13 Complete https://irct.ir/trial/61144 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: During the reconstruction of the body fracture, before the fixation of the fracture, the PRF will be put on the IAN of one side as the treatment group. But, the fixation on the other side will be performed without putting the PRF as the control group. For this purpose, the right or left side will be selected randomly by a software, Blinding description: The neurosensory evaluations at three times including before the surgery (T0), 6 months after the surgery (T1), and 12 months after the surgery (T2) will be performed by an examiner who is unaware of the study groups and surgical process. N/A Inferior Alveolar nerve neurosensory defect due to mandibular body fracture. Intervention 1: Intervention group: Before the fixation of the fracture, the PRF will be put on the IAN of one side as the treatment group. Intervention 2: Control group: The fixation of the fracture will be performed without putting the PRF. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Hamidreza Moslemi
Department of Oral and Maxillofacial Surgery, Shahid Beheshti School of Dentistry, Danshjoo BLVD, Velenjak, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1983963113 +98 21 4044 3580 hmoslemi71@gmail.com Shahid Beheshti University of Medical Sciences scientific Reza Tabrizi
Shahid Beheshti School of Dentistry, Danshjoo BLVD, Velenjak, Shahid Chamran Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983963113 +98 21 4044 3580 tabmed@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The patients with bilateral mandibular body fracture with less than 5mm displacement, who are candidates for open reduction-internal fixation (ORIF) no limit no limit Both Patients with other types of fracture or those who are not a candidate for the ORIF treatment method History of mandible genioplasty or orthognathic surgery History of mandible trauma History of mandibular fracture Obvious perioperative nerve injury Psychiatric medication Refusing to participate in the postoperative examinations Having neuropathic systemic diseases such as diabetes Having no consent for participation in the study S04.3 Injury of trigeminal nerve Treatment - Surgery Treatment - Surgery Intervention group: Before the fixation of the fracture, the PRF will be put on the IAN of one side as the treatment group. Control group: The fixation of the fracture will be performed without putting the PRF The two-point discrimination test (TPD). Timepoint: before the surgery (T0), 6 months after the surgery (T1), and 12 months after the surgery (T2). Method of measurement: the minimum distance of two discriminable points, which is created by a needle on the lower lip and the mental area. The brush directional stroke discrimination test. Timepoint: before the surgery (T0), 6 months after the surgery (T1), and 12 months after the surgery (T2). Method of measurement: performed by movement of a thin brush on the lower lip and the mental area and the patient must recognize the direction of the brush movement. Self reported paresthesia. Timepoint: before the surgery (T0), 6 months after the surgery (T1), and 12 months after the surgery (T2). Method of measurement: using the visual analogue scale with a score range of (1-10) so that scores of (1 to 3), (4 to 6), and (7-10) are defined as mild, moderate, and severe, respectively. Shahid Beheshti University of Medical Sciences Approved 2021-12-13 Research Ethics Committees of Research institute of dental sciences Shahid beheshti university of me Shahid Beheshti School of Dentistry, Danshjoo BLVD, Velenjak, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)