Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT04905758
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2021-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059605', 'term': 'Dental Implant-Abutment Design'}], 'ancestors': [{'id': 'D017267', 'term': 'Dental Prosthesis Design'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013674', 'term': 'Technology, Dental'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Maxi-Z plus dental implant'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant mobility using Periotest M', 'timeFrame': '12 months', 'description': 'Periotest M values range from (-8 to 0). high values represent loose implant, while osseointegrated implants showed low values'}, {'measure': 'marginal bone level', 'timeFrame': '12 months', 'description': 'measured in mm using X-ray'}], 'secondaryOutcomes': [{'measure': 'pink estheic score', 'timeFrame': '12 months', 'description': 'from 0-12. 0 means bad aesthetic of soft tissue. 12 means the ultimate aesthetics of soft tissue'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['platform switched implants', 'platform matched implants'], 'conditions': ['Peri-implant Mucositis', 'Dental Implant Failed']}, 'descriptionModule': {'briefSummary': 'patients were randomly divided into Maxi-Z plus dental implant group versus Maxi-Z implant group', 'detailedDescription': 'after tooth extraction implants will be placed immediately and provisional restoration will be placed in both groups to detect the advantaged and drawbacks of newly designed Maxi-Z plus dental implant versus Maxi-Z dental implant'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good health\n* unrestorable, periodontal healthy teeth\n\nExclusion Criteria:\n\n* systemic disease\n* periodontal disease\n* presence of abscess'}, 'identificationModule': {'nctId': 'NCT04905758', 'briefTitle': 'Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design: Randomised Clinical Study', 'orgStudyIdInfo': {'id': 'assmortada2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maxi-Z plus dental implant', 'description': 'platform switched dental implants', 'interventionNames': ['Procedure: platform switching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Maxi-Z dental implant', 'description': 'platform matched dental implants', 'interventionNames': ['Procedure: platform amtching']}], 'interventions': [{'name': 'platform switching', 'type': 'PROCEDURE', 'description': 'reduced implant abutment interface', 'armGroupLabels': ['Maxi-Z plus dental implant']}, {'name': 'platform amtching', 'type': 'PROCEDURE', 'description': 'matched implant abutment interface', 'armGroupLabels': ['Maxi-Z dental implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '214312', 'city': 'Kafr ash Shaykh', 'state': 'Kafrelsheikh', 'country': 'Egypt', 'facility': 'faculty of dentistry, kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'by the end of August 2021 for 6 months', 'ipdSharing': 'YES', 'description': 'after research results publishing will decide', 'accessCriteria': 'open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of oral medicine and periodontology', 'investigatorFullName': 'Walid Elamrousy', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}