About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Comminuted mandibular fractures Previously treated cases of fractures Patients with history of neurological disorders Comorbid patients
Trial design
Parallel
Treatments tested in this trial
Platelets rich Fibrin
Other interventionPRF is the second generation autologous platelet concentrate that is obtained from patient's own blood in simple and cost effective manner. PRF is comprised of three main specifications. First, the existence of platelets and their active growth factors i.e. platelet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), transforming growth factor (TGF), insulin-like growth factor (IGF) and epidermal growth factor (EGF). Second, the role of leukocytes and cytokines i.e. TNF alpha, IL-6 and IL-1ɓ in anti-inflammatory response and immune modulation. Third, the fibrin meshwork where these platelets, cytokines and growth factors are embedded and subsequently released after a short period
Treatment groups
Trial outcomes
Primary outcomes
Neurosensory Recovery
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: