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

December 20, 2025 updated by: Muhammad umair shakir, University of Health Sciences Lahore

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54550
        • Allama Iqbal Medical College/ Jinnah Hospital Lahore
        • Contact:
        • Principal Investigator:
          • Muhammad Umair Shakir, PGR MDS (OMFS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Case Group
The group in which PRF will be placed over mental nerve during open reduction and internal fixation of patients with mandibular body fractures involving mental foramen.
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
Other Names:
  • PRF
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neurosensory Recovery
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Health Sciences Lahore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dr Gulraiz Zulfiqar, FCPS(OMFS), Associate professor and Head of Department Oral & Maxillofacial Surgery, Allama Iqbal Medical College/ Jinnah Hospital Lahore

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ERB172/ 2 /10-10-2024/S1 ERB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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