Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:32 AM
Study NCT ID:
NCT07319650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Of Platelet Rich Fibrin (PRF) In Neurosensory Disturbance Among Patients With Mandibular Body Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nControl 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-20', 'studyFirstSubmitDate': '2025-12-20', 'studyFirstSubmitQcDate': '2025-12-20', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurosensory Recovery', 'timeFrame': "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", 'description': '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).\n\nTPD \\>20mm = Score 0 14-20mm= Score 1 \\<14mm= Score 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurosensory Disturbance', 'Platelet Rich Fibrin', 'Mandibular body fractures'], 'conditions': ['Neurosensory Disturbance', 'Mandibular Body Fractures']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22624763', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '14895767', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '30954205', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '17656272', 'type': 'BACKGROUND', 'citation': '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': '27371997', 'type': 'BACKGROUND', 'citation': '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': '25383147', 'type': 'BACKGROUND', 'citation': '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': '31293938', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAlternate 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.\n\nNull 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.', 'detailedDescription': '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 .\n\nThe 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.\n\nLimited 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n\nAge 15-40years, Both Gender ASA\\_1\n\nExclusion Criteria:\n\n* Comminuted mandibular fractures Previously treated cases of fractures Patients with history of neurological disorders Comorbid patients"}, 'identificationModule': {'nctId': 'NCT07319650', 'acronym': 'PRF NSD', 'briefTitle': 'Efficacy Of Platelet Rich Fibrin (PRF) In Neurosensory Disturbance Among Patients With Mandibular Body Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Health Sciences Lahore'}, 'officialTitle': 'Efficacy Of Platelet Rich Fibrin (PRF) In Neurosensory Disturbance Among Patients With Mandibular Body Fractures', 'orgStudyIdInfo': {'id': 'ERB172/ 2 /10-10-2024/S1 ERB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Case Group', 'description': '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.', 'interventionNames': ['Other: Platelets rich Fibrin']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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': [{'name': 'Platelets rich Fibrin', 'type': 'OTHER', 'otherNames': ['PRF'], 'description': "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", 'armGroupLabels': ['Case Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54550', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Dr Gulraiz Zulfiqar, FCPS (OMFS)', 'role': 'CONTACT', 'email': 'gulraizoms@yahoo.com', 'phone': '+92 321 4559970'}, {'name': 'Muhammad Umair Shakir, PGR MDS (OMFS)', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Allama Iqbal Medical College/ Jinnah Hospital Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Muhammad Umair Shakir, PGR MDS (OMFS)', 'role': 'CONTACT', 'email': 'umair446109@gmail.com', 'phone': '+92 3127916610'}], 'overallOfficials': [{'name': 'Dr Gulraiz Zulfiqar, FCPS(OMFS)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate professor and Head of Department Oral & Maxillofacial Surgery, Allama Iqbal Medical College/ Jinnah Hospital Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Health Sciences Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate Resident (MDS) Oral & Maxillofacial Surgery', 'investigatorFullName': 'Muhammad umair shakir', 'investigatorAffiliation': 'University of Health Sciences Lahore'}}}}