Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-02 @ 3:06 AM
Study NCT ID:
NCT05285293
Status:
UNKNOWN
Last Update Posted:
2022-03-17
First Post:
2022-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periodontal Regeneration Using Vitamin A and PRF Compared to PRF Alone Treating Intra-bony Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056690', 'term': 'Prolactin-Releasing Hormone'}, {'id': 'D014801', 'term': 'Vitamin A'}], 'ancestors': [{'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-16', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic linear defect depth', 'timeFrame': '6 Month', 'description': 'Measured as the depth of intra-osseous defect from the alveolar crest to the defect base (E et al., 2004)'}], 'secondaryOutcomes': [{'measure': 'Clinical attachment level', 'timeFrame': '6 Month', 'description': 'clinical attachment level measured in mm. using williams graduated probe(SP, 1967)'}, {'measure': 'Probing pocket depth', 'timeFrame': '6 Month', 'description': "Measuring probing depth in mm using William's graduated Periodontal probe (SP, 1967)"}, {'measure': 'Radiographic defect bone density', 'timeFrame': '6 MOnth', 'description': 'Bone density will be measured using Digital Radiographs using ImageJ software (B et al., 2019)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrabony Periodontal Defect']}, 'descriptionModule': {'briefSummary': 'Will the addition of vitamin A (Retinol) to PRF add more periodontal regenerative value in the treatment of intra-bony defects compared to PRF alone, clinically?', 'detailedDescription': 'Vitamin A has been extensively studied for its role in bone health. Vitamin A can be consumed in two forms, i.e., preformed retinol and pro-vitamin A. Preformed retinol is often found in food originated from animals, such as dairy, liver and eggs. Provitamin A, such as alpha (α)-carotene, beta (β)-carotene orβ-cryptoxanthin, are commonly found in plant-based food, such as fruits and vegetables (Toti et al., 2018). At certain concentrations, it has been proven to enhance the pluripotency of periodontal cells for regeneration (Fawzy El-Sayed, Hein and Dörfer, 2019).\n\nYet, to the best of our knowledge no clinical trials have evaluated the effect of Vitamin A added to PRF in the regeneration of intra-bony defects. This study is to fill the gap of knowledge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage III periodontitis patient (Papapanou et al., 2018) with 3 walled or 2 walled intra-bony defects.\n* Non-smokers\n* No pregnancy\n* Medically free\n* Presence of intra-bony defect of three or two walls (as predominant component) with a radiographic intra-bony component of ≥3 mm;\n* Presence of ≥2 mm of keratinized gingiva at the tooth with the defect.\n* Willingness to optimal compliance with the study procedures\n\nExclusion Criteria:\n\n* Uncontrolled systemic or local infection in the tissue of interest,\n* History or clinical evidence or positive tests for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV).\n* History of chronic autoimmune disease\n* Participation in an intervention trial in the same quadrant in the previous two months.\n* Type III tooth mobility, vertical root fracture in the selected tooth.\n* Contraindications for periodontal surgery.'}, 'identificationModule': {'nctId': 'NCT05285293', 'briefTitle': 'Periodontal Regeneration Using Vitamin A and PRF Compared to PRF Alone Treating Intra-bony Defects', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Evaluation of Periodontal Regeneration Using Vitamin A Added to PRF in Comparison to PRF Alone in Treatment of Intra-bony Defects: Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '121221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 Control', 'description': 'PRF in intra-bony defects', 'interventionNames': ['Biological: Platelet Rich Fibrin (PRF)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 Experimental', 'description': 'PRF and Retinol in intra-bony defects', 'interventionNames': ['Biological: Platelet Rich Fibrin (PRF) and Retinol']}], 'interventions': [{'name': 'Platelet Rich Fibrin (PRF)', 'type': 'BIOLOGICAL', 'description': 'Platelet rich fibrin (PRF) in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)', 'armGroupLabels': ['Group 1 Control']}, {'name': 'Platelet Rich Fibrin (PRF) and Retinol', 'type': 'BIOLOGICAL', 'description': 'Platelet rich fibrin (PRF) mixed with Retinol in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)', 'armGroupLabels': ['Group 2 Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Abdallah H. Mostafa, M.Sc.', 'role': 'CONTACT', 'email': 'dr.abdallah.hassan@gmail.com', 'phone': '+2001005682509'}], 'overallOfficials': [{'name': 'Abdallah H. Mostafa, M.Sc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data will be available once the study is over and for one year', 'ipdSharing': 'YES', 'description': 'Inclusion, exclusion criteria, Methodology and Results', 'accessCriteria': 'by emailing " Dr.abdallah.hassan@gmail.com"'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'B.Sc., M.Sc. Abdallah Hassan Mostafa', 'investigatorFullName': 'Abdallah Hassan Mostafa', 'investigatorAffiliation': 'Cairo University'}}}}