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

NCT07319650 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-06

No results posted yet for this study

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.

Conditions

  • Neurosensory Disturbance
  • Mandibular Body Fractures

Interventions

OTHER

Platelets rich Fibrin

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 & Collaborators

  • University of Health Sciences Lahore

    lead OTHER

Principal Investigators

  • Dr Gulraiz Zulfiqar, FCPS(OMFS) · Associate professor and Head of Department Oral & Maxillofacial Surgery, Allama Iqbal Medical College/ Jinnah Hospital Lahore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-01-31
Completion
2027-02-28

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07319650 on ClinicalTrials.gov