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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07319650
Acronym
PRF NSD
Enrollment
40
Registered
2026-01-06
Start date
2026-01-31
Completion date
2027-02-28
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Body Fractures, Neurosensory Disturbance

Keywords

Neurosensory Disturbance, Platelet Rich Fibrin, Mandibular body fractures

Brief summary

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.

Detailed description

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.

Interventions

PRF 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

Sponsors

University of Health Sciences Lahore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Experimental Group= The group in which PRF will be placed over mental nerve during open reduction and internal fixation of patients with mandibular body fractures. Control Group= The group in which PRF will not be placed over mental nerve during open reduction and internal fixation of patients with mandibular body fractures.

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Neurosensory RecoveryPatients 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 monthsNeurosensory 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

Countries

Pakistan

Contacts

Primary ContactMuhammad Umair Shakir, PGR MDS (OMFS)
umair446109@gmail.com+92 3127916610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026