Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT04795102
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2021-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of "Autogenous Leukocyte Platelet Rich Fibrin- Tooth Graft" Combination Around Immediately Placed Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2021-03-07', 'studyFirstSubmitQcDate': '2021-03-10', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical evaluation of bone formation around immediately placed dental implants', 'timeFrame': '9 months', 'description': 'Changes on bone formation using ATBG with or without L-PRF around immediately placed dental implants in periodontally compromised teeth'}, {'measure': 'radiographic outcome around immediately placed dental implants', 'timeFrame': '9 months', 'description': 'the radiographic outcome of ATBG on bone formation with or without L-PRF around immediately placed dental implants in periodontally compromised teeth'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autogenous Tooth Bone Graft', 'Immediate Implant Placement', 'L-PRF']}, 'descriptionModule': {'briefSummary': 'Immediate implant placement into fresh extraction sockets is gaining popularity because of fewer clinical procedures and maintenance of bone architecture compared to conventional methods, thus reducing the treatment time and increasing patient satisfaction. In addition, the survival rate of the immediate implantation is comparable to that of the healed implantation sites. Recently, ATBG made from compromised teeth was applied in bone defects and resulted in a good clinical efficacy. Moreover, it is more accepted by patients to use extracted teeth as a bone graft material, especially in the case of immediate implant placement. In 2020, Kizildağ and coworkers studied the outcome of PRF as an adjunct with ATBG on bone healing in rabbit peri-implant osseous defects. They reported that combination of ATBG with PRF contributed to significantly higher new bone formation and better bone/implant contact in rabbits with peri-implant bone defects. The main hypothesis behind this study is that using L-PRF with ATBG following immediate implant placement could promote stabilization of graft particles and enhance new bone formation with a shorter time. Therefore, the purpose of this study was to compare the clinical and radiographic outcomes of ATBG on bone formation with or without L-PRF around immediately placed dental implants in periodontally compromised teeth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Teeth need to be extracted for periodontal reasons with a defect of labial bone (horizontal or vertical bone defect).\n* the teeth without acute inflammation.\n* no uncontrolled systemic disease which is not suitable for implantation.\n* Good systemic and oral health.\n\nExclusion Criteria:\n\n* patients with systemic diseases or medications known to alter healing processes\n* Psychiatric disorders.\n* Root canal treated teeth.\n* patients undergoing or who had undergone radiation therapy and chemotherapy to the head and neck region during 12 months.\n* patients with para-functional habits.\n* alcoholics.\n* drug abusers.\n* heavy smokers'}, 'identificationModule': {'nctId': 'NCT04795102', 'briefTitle': 'Effect of "Autogenous Leukocyte Platelet Rich Fibrin- Tooth Graft" Combination Around Immediately Placed Implants', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Effect of "Autogenous Leukocyte Platelet Rich Fibrin- Tooth Graft" Combination Around Immediately Placed Implants in Periodontally Compromized Sites: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'KD/03/20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-PRF with ATBG around implant', 'description': 'L-PRF clots to cover ATBG around immediately placed dental implants in the extraction sockets', 'interventionNames': ['Combination Product: immediate implant placement with ATBG and L-PRF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ATBG around implant', 'description': 'ATBG around immediately placed dental implants in the extraction sockets', 'interventionNames': ['Combination Product: immediate implant placement with ATBG']}], 'interventions': [{'name': 'immediate implant placement with ATBG and L-PRF', 'type': 'COMBINATION_PRODUCT', 'description': 'immediate implant placement using ATBG as a graft material, with L-PRF', 'armGroupLabels': ['L-PRF with ATBG around implant']}, {'name': 'immediate implant placement with ATBG', 'type': 'COMBINATION_PRODUCT', 'description': 'immediate implant placement using ATBG as a graft material without L-PRF', 'armGroupLabels': ['ATBG around implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33511', 'city': 'Kafr ash Shaykh', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'overallOfficials': [{'name': 'Dalia R Issa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kafrelsheikh University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dalia Rasheed Issa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Dalia Rasheed Issa', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}