Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT06368869
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers
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', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2024-04-12', 'studyFirstSubmitQcDate': '2024-04-12', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Color stability assessment', 'timeFrame': 'up to 12 months', 'description': 'VITA Easyshade® Advance spectrophotometer will be used to measure the shade on the CIELab system, which defines color on 3 axes: L\\*, lightness, ranging from 0 (black) to 100 (white); and a\\* and b\\*, chromatic characteristics ranging from red (+a\\*) to green (-a\\*) and yellow (+b\\*) to blue (-b\\*) The color will be measured 3 times, and the mean L\\*, a\\*, and b\\* values will be calculated and used to measure color change (delta E)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Color; Change Teeth, Posteruptive']}, 'descriptionModule': {'briefSummary': 'Aim of the study was to evaluate the color stability of lithium disilicate ceramic veneers and zirconia reinforced lithium silicate ceramic veneers by using two different types of resin cements including light cured and dual cured cements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good oral hygiene with compliance to perform strict oral hygiene measures (periodontal screening index 0-1).\n* Slight malposition.\n* Teeth with spacing.\n* Teeth with discoloration\n\nExclusion Criteria:\n\n* Advanced periodontitis, gingivitis, or recession.\n* Abutments with subgingival restorations or root caries.\n* Parafunctional habits.\n* Undergoing orthodontic treatment.\n* Presence of orthodontic appliance.\n* Obvious dentition malalignment.\n* Mandibular prognathism.\n* Maxillary retrognathism.\n* Smokers.'}, 'identificationModule': {'nctId': 'NCT06368869', 'briefTitle': 'The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers (Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '#1/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Livento press veneers luted with dual cured resin cement', 'interventionNames': ['Other: Livento press veneers luted with dual cured resin cement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Livento press veneers luted with light cured resin cement', 'interventionNames': ['Other: Livento press veneers luted with light cured resin cement']}, {'type': 'EXPERIMENTAL', 'label': 'Celtra duo veneers luted with dual cured resin cement', 'interventionNames': ['Other: Celtra duo veneers luted with dual cured resin cement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Celtra duo veneers luted with light cured resin cement', 'interventionNames': ['Other: Celtra duo veneers luted with light cured resin cement']}], 'interventions': [{'name': 'Livento press veneers luted with dual cured resin cement', 'type': 'OTHER', 'description': 'Veneers will be fabricated using Lithium disilicate (Livento® Press) ceramic and luted using Bifix QM dual cured cement', 'armGroupLabels': ['Livento press veneers luted with dual cured resin cement']}, {'name': 'Livento press veneers luted with light cured resin cement', 'type': 'OTHER', 'description': 'Veneers will be fabricated using Lithium disilicate (Livento® Press) ceramic and luted using Bisco choice 2 light cured cement', 'armGroupLabels': ['Livento press veneers luted with light cured resin cement']}, {'name': 'Celtra duo veneers luted with dual cured resin cement', 'type': 'OTHER', 'description': 'Veneers will be fabricated using Zirconia-reinforced lithium silicate (Celtra® Press) ceramic and luted using Bifix QM dual cured cement', 'armGroupLabels': ['Celtra duo veneers luted with dual cured resin cement']}, {'name': 'Celtra duo veneers luted with light cured resin cement', 'type': 'OTHER', 'description': 'Veneers will be fabricated using Zirconia-reinforced lithium silicate (Celtra® Press) ceramic and luted Bisco choice 2 light cured cement', 'armGroupLabels': ['Celtra duo veneers luted with light cured resin cement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'amr elshimy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Fixed Prosthodontics', 'investigatorFullName': 'amr elshimy', 'investigatorAffiliation': 'Alexandria University'}}}}