Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06016218
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2023-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-08-23', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in crestal peri-imlant Bone', 'timeFrame': '12 months', 'description': 'Radiographic evaluation of crestal bone changes around the studied implants'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries Extending to Pulp', 'Dental Implant Failed']}, 'descriptionModule': {'briefSummary': 'This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not.\n\nThis will be done through:\n\n1. Measuring bone changes around the implant by cone beam\n2. Measuring change in bone density around the implants\n\nB- Evaluate the effect of statins on osteoblasts activity and expression of various osteogenic products in vitro.', 'detailedDescription': 'Twenty four patients requiring rehabilitation by immediate implantation in an extraction socket were recruited for this study. The Patients were divided into three groups (n=8), For the first group; immediately after extraction, PRF alone was added into the extraction socket prior to implant insertion. For the second group, PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion. For the third Group; PRF + Bone powder are inserted into the extraction site before implant insertion. A conebeam CT was used to evaluate the effect on bone changes and bone density around implant sites, for every patient in all implant groups immediately after the surgery and at follow-up time. In vitro experiment: isolation of human Adipose mesenchymal stem cells (hAd-MSCs), characterization and osteogenic differentiation will be done. The cells were divided into two groups one control group and the other statin group. Osteogenic markers were measured in both groups and statistical analysis performed'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Badly Broken Down Tooth requiring extraction\n* Medically Free\n* Any other procedures or surgeries were performed 6 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 like psychologically unstable patients.'}, 'identificationModule': {'nctId': 'NCT06016218', 'briefTitle': 'Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'Effect of Local Application of Platelet-Rich Fibrin Scaffold Loaded With Simvastatin Versus Bone Powder on Peri-Implant Bone Changes', 'orgStudyIdInfo': {'id': '260981'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'PRF', 'description': 'PRF alone was added to extraction site prior to implant insertion', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SIM+ PRF', 'description': 'PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BO+ PRF', 'description': 'PRF + Bone powder are inserted into the extraction site before implant insertion.', 'interventionNames': ['Drug: Simvastatin']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'description': 'Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone', 'armGroupLabels': ['BO+ PRF', 'PRF', 'SIM+ PRF']}]}, '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': 'SPONSOR'}}}}