Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT04298294
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2020-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using of Injectable Platelet Rich Fibrin on Filling the Gap of Immediate Dental Implant
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blinded'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group I (study group)8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with i-PRF\\& bone graft\n\nGroup II (control group) 8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with bone graft'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2020-02-29', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiograhic evaluation of the effect of i-PRF on filling the buccal gap distance between the immediately placed dental implant and the surrounding bone.', 'timeFrame': '6 months follow up', 'description': 'density, vertical and horizontal assessment of labial plate'}, {'measure': 'Radiographic analysis', 'timeFrame': '6 months follow up', 'description': 'vertical assessment of labial plate'}, {'measure': 'Radiographic analysis', 'timeFrame': '6 months follow up', 'description': 'density of labial plate'}], 'secondaryOutcomes': [{'measure': 'Esthetic evaluation of the effect of i-PRF on the soft tissue around immediately placed dental implant', 'timeFrame': '6 months follow up', 'description': 'pink esthetic score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Loss']}, 'descriptionModule': {'briefSummary': 'The effect of using of i-PRF (injectable platelet rich fibrin) on filling the gap of immediate dental implant in the esthetic zone', 'detailedDescription': 'Grouping the samples: (sixteen patients was recruited from the outpatient clinic of Oral Medicine, Periodontology, Diagnosis and Radiology Department, Faculty of Dentistry, Ain Shams University).\n\nThe sixteen patients assigned to group 1 or group 2 will be randomly allocated using flip of a coin into one of the 2 treatment modalities.\n\nPrimary objective:\n\nRadiograhic evaluation of the effect of i-PRF on filling the buccal gap distance between the immediately placed dental implant and the surrounding bone.\n\nSecondary objective:\n\nEsthetic evaluation of the effect of i-PRF on the soft tissue around immediately placed dental implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult patient.\n* Age from 20-50 years old\n* Patients must be free of any systemic disease which could influence the surgical procedure.\n* Tooth involved in the esthetic zone.\n* Sufficient hard and soft tissue volume in vertical and buccolingual 6. Natural teeth adjacent to the involved tooth were required to be free from infection.\n* Controlled oral hygiene.\n* Indication for tooth extraction included;\n\n * Endodontic failures\n * Untreatable caries\\> Non- restorable teeth\n * Vertical root fracture\n * Remaining roots\n* The decision to proceed with the implant placement was made after tooth extraction and probing of the extraction socket which revealed:\n\n * The presence of intact facial bone.\n * Compliance with all requirements in the study and signing the informed consent.\n\nExclusion Criteria:\n\n* Patient had surgeries in the same site during the last 6 months prior to the surgery.\n* Severe vertical bone loss (socket type lll or type lV).\n* Presence of acute dento-alveolar infection or periodontal affected of involved tooth.\n* Pregnant and lactating females.\n* Smokers.'}, 'identificationModule': {'nctId': 'NCT04298294', 'briefTitle': 'Using of Injectable Platelet Rich Fibrin on Filling the Gap of Immediate Dental Implant', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Effect of Using of Injectable Platelet Rich Fibrin on Filling the Gap of Immediate Dental Implant in the Esthetic Zone', 'orgStudyIdInfo': {'id': 'Bassant Mohye'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'injectable platelet rich fibrin group', 'description': '8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with i-PRF\\& bone graft', 'interventionNames': ['Other: injectable platelet rich fibrin']}, {'type': 'NO_INTERVENTION', 'label': 'no injectable platelet rich fibrin group', 'description': '8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with bone graft'}], 'interventions': [{'name': 'injectable platelet rich fibrin', 'type': 'OTHER', 'description': 'biologic activator', 'armGroupLabels': ['injectable platelet rich fibrin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11724', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Bassant Mohye', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bassant Mohye', 'investigatorAffiliation': 'Ain Shams University'}}}}