Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-22 @ 1:40 PM
Study NCT ID:
NCT05878392
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2023-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Implant With Different Filling Materials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2023-05-18', 'lastUpdatePostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'marginal bone loss', 'timeFrame': '1 year', 'description': 'Cone Beam CT (CBCT) was used measure marginal bone loss'}], 'secondaryOutcomes': [{'measure': 'Implant Stability:', 'timeFrame': '1 year', 'description': 'Resonance frequency analysis (RFA) was used to measure implant stability with an Osstell Mentor device.'}, {'measure': 'Peri-implant Pocket depth', 'timeFrame': '1 year', 'description': 'A graduated probe was used to measure the distance between the base of the pocket and the gingival margin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immediate Implant']}, 'referencesModule': {'references': [{'pmid': '38066454', 'type': 'DERIVED', 'citation': 'Elsheikh HA, Abdelsameaa SE, Elbahnasi AA, Abdel-Rahman FH. Comparison between platelet rich fibrin as space filling material versus xenograft and alloplastic bone grafting materials in immediate implant placement: a randomized clinical trial. BMC Oral Health. 2023 Dec 8;23(1):977. doi: 10.1186/s12903-023-03678-5.'}]}, 'descriptionModule': {'briefSummary': '36 patients, were included in this study. They were chosen from the Outpatient Clinic in the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable maxillary anterior and premolar teeth (esthetic zone) by immediate implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient medically free from systemic diseases.\n* Age above 18 years.\n* A single maxillary anterior or premolar tooth that cannot be restored.\n* No acute infection is present.\n* Patients with sufficient quality and quantity of bone.\n* Free from history of bruxism.\n\nExclusion Criteria:\n\n* A medical condition that would prevent implant surgery.\n* Existence of non-treated generalized progressive periodontitis.\n* Patients who are smokers.'}, 'identificationModule': {'nctId': 'NCT05878392', 'briefTitle': 'Immediate Implant With Different Filling Materials', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Comparison Between Different Filling Materials in Immediate Implant', 'orgStudyIdInfo': {'id': 'A0103023OS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'description': 'immediate implant placement and the buccal jumping gap was packed using PRF', 'interventionNames': ['Other: bone filling materials']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'description': 'immediate implant placement and the buccal jumping gap was packed using xenograft', 'interventionNames': ['Other: bone filling materials']}, {'type': 'EXPERIMENTAL', 'label': 'group 3', 'description': 'immediate implant placement and the buccal jumping gap was packed using alloplast', 'interventionNames': ['Other: bone filling materials']}], 'interventions': [{'name': 'bone filling materials', 'type': 'OTHER', 'description': 'the buccal jumping gap was packed using PRF in group 1 the buccal jumping gap was packed using xenograft in group 2 the buccal jumping gap was packed using Alloplastic β-tricalcium phosphate in group 3', 'armGroupLabels': ['group 1', 'group 2', 'group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Mansoura, Egypt', 'country': 'Egypt', 'facility': 'Heba Elsheikh', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}