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

NCT07319650 | Not Yet Recruiting

• 1 other identifier: ERB172/ 2 /10-10-2024/S1 ERB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurosensory Disturbance; Mandibular Body Fractures

Keywords

Neurosensory Disturbance; Platelet Rich Fibrin; Mandibular body fractures

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (2)

Case Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Platelets rich Fibrin OTHER

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

Also known as: PRF

Case Group

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

Allama Iqbal Medical College/ Jinnah Hospital Lahore

Lahore, Punjab Province, 54550, Pakistan

Location

Related Publications (11)

• Yadav S, Sachdeva A, Verma A.2011. Inferior alveolar nerve damage following removal of mandibular third molar teeth. Journal of Innovative Dentistry, 1:1-4.

  BACKGROUND

• Wu CL, Lee SS, Tsai CH, Lu KH, Zhao JH, Chang YC. Platelet-rich fibrin increases cell attachment, proliferation and collagen-related protein expression of human osteoblasts. Aust Dent J. 2012 Jun;57(2):207-12. doi: 10.1111/j.1834-7819.2012.01686.x.

  PMID: 22624763 BACKGROUND

• Thurmüller P, Dodson TB, Kaban LB.2001. Nerve injuries associated with facial trauma: natural history, management, and outcomes of repair. Oral Maxillofac Surg Clin,13:283-293.

  BACKGROUND

• SUNDERLAND S. A classification of peripheral nerve injuries producing loss of function. Brain. 1951 Dec;74(4):491-516. doi: 10.1093/brain/74.4.491. No abstract available.

  PMID: 14895767 BACKGROUND

• Reza Tabrizi, DMD1, Hamidreza Moslemi, DMD2, Shervin Shafiei, DMD1,Ramtin Dastgir, DDS3 and Zachary S. Peacock, DMD, MD.2024.FACS4Craniomaxillofacial Trauma &Reconstruction , Vol. 0(0) 1-7

  BACKGROUND

• Tabrizi R, Pourdanesh F, Jafari S, Behnia P. Can platelet-rich fibrin accelerate neurosensory recovery following sagittal split osteotomy? A double-blind, split-mouth, randomized clinical trial. Int J Oral Maxillofac Surg. 2018 Aug;47(8):1011-1014. doi: 10.1016/j.ijom.2018.04.010. Epub 2018 May 4.

  PMID: 30954205 BACKGROUND

• Padmaraj Hegde, Bhadrinath Sai Swaroop, Tripthi Shetty.2021.Department of Oral and Maxillofacial Surgery, NITTE University, AB Shetty Memorial Institute of Dental Sciences 575018, Mangalore, INDIA Nat. Volatiles & Essent. Oils,8(5):10566-10571

  BACKGROUND

• Libersa P, Savignat M, Tonnel A. Neurosensory disturbances of the inferior alveolar nerve: a retrospective study of complaints in a 10-year period. J Oral Maxillofac Surg. 2007 Aug;65(8):1486-9. doi: 10.1016/j.joms.2007.03.023.

  PMID: 17656272 BACKGROUND

• Khojasteh A, Hosseinpour S, Nazeman P, Dehghan MM. The effect of a platelet-rich fibrin conduit on neurosensory recovery following inferior alveolar nerve lateralization: a preliminary clinical study. Int J Oral Maxillofac Surg. 2016 Oct;45(10):1303-8. doi: 10.1016/j.ijom.2016.06.003. Epub 2016 Jun 30.

  PMID: 27371997 BACKGROUND

• Boffano P, Roccia F, Gallesio C, Karagozoglu K, Forouzanfar T. Inferior alveolar nerve injuries associated with mandibular fractures at risk: a two-center retrospective study. Craniomaxillofac Trauma Reconstr. 2014 Dec;7(4):280-3. doi: 10.1055/s-0034-1375169. Epub 2014 Jun 5.

  PMID: 25383147 BACKGROUND

• Abhinav RP, Selvarasu K, Maheswari GU, Taltia AA. The Patterns and Etiology of Maxillofacial Trauma in South India. Ann Maxillofac Surg. 2019 Jan-Jun;9(1):114-117. doi: 10.4103/ams.ams_233_18.

  PMID: 31293938 BACKGROUND

Study Officials

• Dr Gulraiz Zulfiqar, FCPS(OMFS)

  Associate professor and Head of Department Oral & Maxillofacial Surgery, Allama Iqbal Medical College/ Jinnah Hospital Lahore

  STUDY DIRECTOR

Central Study Contacts

Muhammad Umair Shakir, PGR MDS (OMFS)

CONTACT

+92 3127916610; umair446109@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident (MDS) Oral & Maxillofacial Surgery

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

PA (1)