Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-31 @ 7:02 PM
Study NCT ID:
NCT06721806
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-06
First Post:
2024-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Platelet Rich Plasma in Bone Regeneration After Enucleation of Odontogenic Jaw Cysts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007570', 'term': 'Jaw Cysts'}], 'ancestors': [{'id': 'D001845', 'term': 'Bone Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001861', 'term': 'Bone Regeneration'}], 'ancestors': [{'id': 'D016723', 'term': 'Bone Remodeling'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012038', 'term': 'Regeneration'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-11', 'size': 425172, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-11-12T17:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone healing', 'timeFrame': '6 months', 'description': 'effect of PRP in bone healing by measuring bone density'}, {'measure': 'PRP & infection rate', 'timeFrame': '6 months', 'description': 'PRP reduce infection rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PRP & Jaw Cysts']}, 'referencesModule': {'references': [{'pmid': '37261171', 'type': 'BACKGROUND', 'citation': 'Tiwari A. A Traumatic Ulcer Caused by Accidental Lip Biting Following Topical Anesthesia: A Case Report. Cureus. 2023 Apr 29;15(4):e38316. doi: 10.7759/cureus.38316. eCollection 2023 Apr.'}, {'pmid': '16504849', 'type': 'BACKGROUND', 'citation': 'Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.'}, {'pmid': '16504850', 'type': 'BACKGROUND', 'citation': 'Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.'}, {'pmid': '19573909', 'type': 'BACKGROUND', 'citation': 'Intini G. The use of platelet-rich plasma in bone reconstruction therapy. Biomaterials. 2009 Oct;30(28):4956-66. doi: 10.1016/j.biomaterials.2009.05.055. Epub 2009 Jul 1.'}, {'pmid': '36110657', 'type': 'BACKGROUND', 'citation': 'Rathore A, Tiwari A, Nazim M, Gupta AK, Gande M, Krishnakumar J. Detection of Human PapillomaVirus and its Association with Potentially Malignant Disorders and Oral Squamous Cell Carcinoma: A Retrospective Study. J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S820-S824. doi: 10.4103/jpbs.jpbs_9_22. Epub 2022 Jul 13.'}, {'pmid': '25624621', 'type': 'BACKGROUND', 'citation': "Raghavendra KM, Sara TB, Mariam VJ, Bhat GS. Author's reply: Platelet-rich fibrin as an adjunct to palatal wound healing after harvesting a free gingival graft: A case series. J Indian Soc Periodontol. 2014 Nov-Dec;18(6):684-5. doi: 10.4103/0972-124X.147397. No abstract available."}, {'pmid': '25024559', 'type': 'BACKGROUND', 'citation': 'Kulkarni MR, Thomas BS, Varghese JM, Bhat GS. Platelet-rich fibrin as an adjunct to palatal wound healing after harvesting a free gingival graft: A case series. J Indian Soc Periodontol. 2014 May;18(3):399-402. doi: 10.4103/0972-124X.134591.'}]}, 'descriptionModule': {'briefSummary': 'in the present study, the effect of PRP on bone regeneration when applied to the site of removal of cyst of the jaws is evaluated. PRP was delivered to the site combined with gelfoam. Thrombin clot accelerator was not used.', 'detailedDescription': "Jaw cysts are common lesions in the oral and maxillofacial region. Enucleation of cyst wall \\& curettage has evolved as the treatment of choice. In order to reduce infections and to accelerate bone regeneration, by using of Platelet rich plasma.\n\nPlatelets are involved in regeneration at sites of pathology, apart from their role in clotting. A preparation composed mainly of platelets (platelet-rich plasma gel) applied to sites of bony pathology, after surgical treatment of lesions, may hasten bone regeneration.\n\nAn interesting idea developed that the addition of a concentrate of platelets, to wounded tissues or surgical sites, may enhance the body's natural wound healing mechanisms . Platelet-rich plasma (PRP) is the accepted term to describe the preparation made out of autologous platelets suspended in autologous plasma, in concentration greater than normally found in peripheral blood Because it is autologous, PRP avoids the risk of transmissible diseases such as HIV, Hepatitis B, C or D and other blood-borne pathogens .A clot accelerator such as bovine thrombin is added to gel the PRP or PRP is added to other materials such as collagen, gelfoam, etc."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Size of the cyst more than 2 cm\n2. The lesion could be visualized radiographically\n3. Patients within the age range of 20 to 50 years\n\nExclusion Criteria:\n\n1. Patients who were alcoholics \\& smokers\n2. -Patients with systemic diseases\n3. History of bleeding tendencies, blood dyscrasia\n4. Low platelet count\n5. Patients unable or unwilling to return for follow-up'}, 'identificationModule': {'nctId': 'NCT06721806', 'briefTitle': 'Role of Platelet Rich Plasma in Bone Regeneration After Enucleation of Odontogenic Jaw Cysts', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Platelet Rich Plasma in Bone Regeneration After Enucleation of Odontogenic Jaw Cysts', 'orgStudyIdInfo': {'id': 'PRP & bone healing'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PRP and bone regeneration after enucleation of odontogenic jaw cysts', 'description': 'effect of PRP on regeneration', 'interventionNames': ['Procedure: PRP & bone regeneration']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'bone regeneration power without PRP', 'description': 'bone healing without use of PRP', 'interventionNames': ['Procedure: PRP & bone regeneration']}], 'interventions': [{'name': 'PRP & bone regeneration', 'type': 'PROCEDURE', 'description': 'PRP effect on bone healing', 'armGroupLabels': ['PRP and bone regeneration after enucleation of odontogenic jaw cysts', 'bone regeneration power without PRP']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maikel M G Morkos, dr', 'role': 'CONTACT', 'email': 'Michael.16266363@med.aun.edu.eg', 'phone': '+201271267725'}, {'name': 'Samy Masoud, prof .dr', 'role': 'CONTACT', 'email': 'samyosman@aun.edu.eg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Maikel Merit Gerges Morkos', 'investigatorAffiliation': 'Assiut University'}}}}