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临床试验/NCT07319650
NCT07319650尚未招募不适用

Efficacy Of Platelet Rich Fibrin (PRF) In Neurosensory Disturbance Among Patients With Mandibular Body Fractures

University of Health Sciences Lahore1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Neurosensory Recovery

研究概览

简要总结

Mandibular body fractures frequently result in inferior alveolar nerve (IAN) and mental nerve injuries which ultimately leads to paresthesia of chin and lower lip area. The objective of this study is to evaluate the efficacy of platelet rich fibrin (PRF) application to mental nerve during open reduction and internal fixation (ORIF) of patients having neurosensory disturbance (NSD) following mandibular body fracture involving mental foramen. The PRF application to mental nerve in mandibular body fractures will not only aid in hard and soft tissue healing but also prove to be a game changer for a holistic healing of a patient rather than separate surgical procedures for nerve repair such as microsurgery, grafting, tissue glues, laser.

Alternate Hypothesis HA= The application of PRF to the mental nerve during open reduction and internal fixation of mandibular body fractures involving the mental foramen significantly improves neurosensory recovery compared to cases where PRF is not applied.

Null Hypothesis HO= The application of PRF to the mental nerve during open reduction and internal fixation of mandibular body fractures involving the mental foramen does not significantly improve neurosensory recovery compared to cases where PRF is not applied.

详细描述

Oral and Maxillofacial surgical procedures such as maxillofacial trauma treatments,TMJ surgeries, cyst enucleation, tumor resection, orthognathic surgeries may result in nerve injuries. Bilateral sagittal split osteotomy can result in damage to IAN nerve. Mandibular fractures can result in damage to IAN/ mental nerve as result of trauma. The frequency of temporary IAN injury is 0.5-5%, whereas permanent injury is <1% and can result in numbness or paresthesia in lower lip and chin area .

The use of PRF may provide a beneficial effect in virtue because it contains several growth factors and may enhance epineurium fibroblast regeneration. PRF has better efficacy than PRP and normal saline (control) in functional nerve recovery (Khojasteh et al.,2016). The use of PRF placement in mandibular body fractures will not only aid in hard and soft tissue healing but also prove to be a game changer for a holistic healing of a patient (Preponement et al.,2013) rather than separate surgical procedures for nerve repair such as microsurgery, grafting, tissue glues, laser.

Limited studies have been done regarding the role of PRF in neurosensory disturbance following mandibular body fractures. The most recent study conducted by Tabrizi et al.(2024) who studied the role of PRF in neurosensory recovery following mandibular body fractures. In this study PRF was placed on IAN between fracture segments. This study had several limitations such as low sample size and there was no direct application of PRF to mental nerve, which may be a factor in NSD. The actual sample size was lower i.e 25 patients as compared to their calculated sample size i.e 30, because 5 patients did not return for follow-up. Our study will provide more significant data related to efficacy of PRF application to mental nerve in patients having neurosensory disturbance following mandibular body fracture involving mental foramen. The PRF application to mental nerve in mandibular body fractures will not only aid in hard and soft tissue healing but also prove to be a game changer for a holistic healing of a patient rather than separate surgical procedures for nerve repair such as microsurgery, grafting, tissue glues, laser.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
15 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having neurosensory disturbance following mandibular body fracture involving mental foramen and pre-operative TPD discrimination score '0' or '1' will be selected in this study ( as per operational definition). TPD discrimination will be recorded; Preoperatively Immediately post operatively After 6 months
  • Age 15-40years, Both Gender ASA_1

排除标准

  • Comminuted mandibular fractures Previously treated cases of fractures Patients with history of neurological disorders Comorbid patients

结局指标

主要结局

Neurosensory Recovery

时间窗: Patients having NSD following mandibular body fractures involving mental foramen and pre-operative TPD discrimination score '0' or '1' will be selected in this study .TPD discrimination will be recorded; Preoperatively Immediately After six months

Neurosensory disturbance in patients following mandibular body fractures involving mental foramen will be assessed using Two-point discrimination as the primary variable. TPD will be recorded as the minimum distance between two pinpricks that patient could recognize at lower lip and chin area. TPD will be performed by placing a sliding caliper on the skin of chin and mucosa of lower lip. Following scoring criteria has been used in literature (khojasteh et al.,2016). TPD \>20mm = Score 0 14-20mm= Score 1 \<14mm= Score 2

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad umair shakir

Postgraduate Resident (MDS) Oral & Maxillofacial Surgery

University of Health Sciences Lahore

研究点 (1)

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