Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT04320758
Status:
UNKNOWN
Last Update Posted:
2020-09-17
First Post:
2020-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
One Year Clinical Evaluation of Translucent Zirconia Crowns in Dental Esthetic Zone With Biologically Oriented Preparation Technique (BOPT) Versus Conventional Preparation (Randomized Clinical Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal adaptation', 'timeFrame': '1 year', 'description': 'Measured using Modified USPHS criteria1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Single Crowns in Aesthetic Dental Zone']}, 'descriptionModule': {'briefSummary': 'Aim of the studyto evaluate the clinical behavior of translucent zirconia crown in dental esthetic zone with biologically oriented preparation technique versus conventional preparation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects are required to be:\n\n 1. From 21-35 years old, be able to read and sign the informed consent document.\n 2. Have no active periodontal or pulpal diseases, have teeth with good restorations\n 3. Psychologically and physically able to withstand conventional dental procedures\n 4. Patients with teeth problems indicated for single all ceramic restoration in maxillary esthetic zone cr\n\n 1. Badly decayed teeth\n 2. Teeth restored with large filling restorations\n 3. Endodontically treated teeth\n 4. Malformed teeth\n 5. Malposed teeth (Tilted, over-erupted, rotated, etc.)\n 6. Spacing between maxillary teeth in esthetic zone\n 5. Able to return for follow-up examinations and evaluation\n\nExclusion Criteria:\n\n1. Patient less than 21or more than 35 years\n2. Patient with active resistant periodontal diseases\n3. Patients with poor oral hygiene and uncooperative patients\n4. Pregnant women\n5. Patients in the growth stage with partially erupted teeth\n6. Psychiatric problems or unrealistic expectations\n7. Patient with periodontal problems\n8. patients with malocclusion or parafunctional habits'}, 'identificationModule': {'nctId': 'NCT04320758', 'briefTitle': 'One Year Clinical Evaluation of Translucent Zirconia Crowns in Dental Esthetic Zone With Biologically Oriented Preparation Technique (BOPT) Versus Conventional Preparation (Randomized Clinical Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'One Year Clinical Evaluation of Translucent Zirconia Crowns in Dental Esthetic Zone With Biologically Oriented Preparation Technique (BOPT) Versus Conventional Preparation (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '2019-09-30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single crown in dental aesthetic zone', 'description': 'teeth in dental aesthetic zone', 'interventionNames': ['Other: conventional preparation design']}, {'type': 'EXPERIMENTAL', 'label': 'teeth need single crown in dental aesthetic zone', 'description': 'teeth in dental aesthetic zone', 'interventionNames': ['Other: biologically oriented preparation technique']}], 'interventions': [{'name': 'conventional preparation design', 'type': 'OTHER', 'otherNames': ['horizontal preparation technique'], 'description': 'chamfer finish line', 'armGroupLabels': ['single crown in dental aesthetic zone']}, {'name': 'biologically oriented preparation technique', 'type': 'OTHER', 'otherNames': ['vertical perpetration technique'], 'description': 'shoulder less preparation design', 'armGroupLabels': ['teeth need single crown in dental aesthetic zone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Cairo', 'state': 'New Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'kareem talaat Ali, M,D,s', 'role': 'CONTACT', 'email': 'kareemtalaat@dentistry.edu.eg', 'phone': '01002225212', 'phoneExt': '02'}], 'facility': 'Faculty of dentistry Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Kareem Talaat Ali, M>D>s', 'role': 'CONTACT', 'email': 'kareemtalaat@dentistry.cu.edu.eg', 'phone': '01002225212', 'phoneExt': '002'}, {'name': 'Amina Zaki', 'role': 'CONTACT', 'email': 'aminazaki@dentistry.cu.edu.eg', 'phone': '01065550016', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident,Fixed Prosthodontics Department,Faculty of Dentistry', 'investigatorFullName': 'Kareem Talaat Abdelwahab Ahmed Ali', 'investigatorAffiliation': 'Cairo University'}}}}