Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT05008068
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2021-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-09', 'studyFirstSubmitDate': '2021-08-02', 'studyFirstSubmitQcDate': '2021-08-09', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The measurement of bone thickness', 'timeFrame': 'After 3 months of the osteotomy and application of Simvastatin', 'description': 'Measuring unit in millimeters , measuring device is CBCT software'}, {'measure': 'The measurement of bone thickness', 'timeFrame': 'After 6 months of the osteotomy and application of Simvastatin', 'description': 'Measuring unit in millimeters , measuring device is CBCT software'}, {'measure': 'The measurement of bone thickness', 'timeFrame': 'After 12 months of the osteotomy and application of Simvastatin', 'description': 'Measuring unit in millimeters , measuring device is CBCT software'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platelet-rich fibrin', 'Simvastatin', 'Bone loss', 'Peri-implant Bone Changes'], 'conditions': ['Platelet-rich Fibrin', 'Simvastatin']}, 'descriptionModule': {'briefSummary': 'ACKGROUND: Simvastatin (SIM), a pharmacological drug used for hypercholesterolemia, has been found to have pleotropic effects on bones. Simvastatin together with the appropriate carrier may decrease bone loss around implants.\n\nPURPOSE: To compare the long term effects of autologous PRF alone, and PRF loaded with SIM on peri-implant bone changes and implant stability in patients undergoing implant rehabilitation.\n\nMATERIALS AND METHODS: A randomized controlled split-mouth studyincluding 8 males between the ages of 45-60 years. Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy. A cone-beam CT was used to evaluate bone changes around the insertion of implant sites atthree, six, and twelve months postoperatively. The secondary outcome included measuring implant stability using Ostell device at baseline and 3 months post insertion. To compare groups at different time periods, data was examined using a two-way (ANOVA) analysis.'}, 'eligibilityModule': {'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with a partially edentulous mandible indicated for rehabilitation with implant prostheses,\n* any extractions, or surgeries performed at least six months earlier.\n\nExclusion Criteria:\n\n* patients with systemic diseases affecting bone quality or resorption\n* temporomandibular joint dysfunction,\n* severe attrition or parafunctional habits,\n* patients undergoing radiotherapy or chemotherapy,\n* heavy smokers,\n* vulnerable groups such as psychologically unstable patients'}, 'identificationModule': {'nctId': 'NCT05008068', 'briefTitle': 'Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes', 'orgStudyIdInfo': {'id': '0012490'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRF alone', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PRF in addition to Simvastatin', 'interventionNames': ['Drug: Simvastatin']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'description': 'Simvastatin with PRF at site of osteotome', 'armGroupLabels': ['PRF alone', 'PRF in addition to Simvastatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'The British University in EGYPT', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Sara Fikry El Shafei', 'investigatorAffiliation': 'British University In Egypt'}}}}