Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT05315518
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2022-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Using Shade Blocker Versus Chameleon Effect of Two Single Shade of Resin Composite in Class IV Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014075', 'term': 'Tooth Discoloration'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-04-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2022-03-17', 'studyFirstSubmitQcDate': '2022-04-04', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'shade matching', 'timeFrame': '12 months', 'description': 'the shade matching of both groups will be assessed visually by using modified USPH criteria.\n\nscore: 1- Alpha : the restoration match the shade and translucency of the adjacent tooth 2-Bravo : there is a mismatch in the shade and translucency but it is within a normal range of tooth shade 3- Charlie: the mismatch is beyond the normal range of the tooth shade and translucency'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Discoloration, Tooth']}, 'descriptionModule': {'briefSummary': 'Aim of this study will be conducted to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade of universal resin composite in class IV restorations over 1 year evaluation period', 'detailedDescription': 'The color matching of both groups will be evaluated visually using modified USPH criteria'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nmoderate class IV defect with no lingual wall presence of favorable occlusion and teeth are in normal contact with the adjacent teeth good oral hygiene cooperative patients\n\n\\-\n\nExclusion Criteria:\n\n* tooth hypersensitivity severe periodontal affection non vital teeth heavy smoking'}, 'identificationModule': {'nctId': 'NCT05315518', 'briefTitle': 'Effect of Using Shade Blocker Versus Chameleon Effect of Two Single Shade of Resin Composite in Class IV Restorations', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Using Shade Blocker Versus Chameleon Effect on Shade Matching of Two Single-shade Resin Composite Materials in Class IV Restorations: A One Year Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'OPR 14/3/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single shade universal resin composite (omnichroma) with blocker', 'description': '(OMNICHROMA BLOCKER) is indicated for preventing shade-matching interference in Class IV restorations, Masking dark dentition and dentin. In cases where there is a lack of tooth structure to bond to, (BLOCKER) works as a supplementary product to provide a lingual wall to the restoration, prevent shade-match obstruction and mask staining.', 'interventionNames': ['Diagnostic Test: single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'single shade universal resin composite(GC solare sculpt) with chameleon effect', 'description': 'One-shade universal resin composite (GC solare sculpt) gives very natural appearance, High gloss retention over time, time saving regarding to layering technique, wide shade matching range (chameleon effect) and delivering lifelike aesthetic restorations. These features can be offered by supra-nano spherical filler which have controlled refractive index, records excellent esthetic properties in small and medium class IV restorations.', 'interventionNames': ['Diagnostic Test: single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)']}], 'interventions': [{'name': 'single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)', 'type': 'DIAGNOSTIC_TEST', 'description': '(OMNICHROMA BLOCKER) is indicated for preventing shade-matching interference in Class IV restorations, Masking dark dentition and dentin. In cases where there is a lack of tooth structure to bond to, (BLOCKER) works as a supplementary product to provide a lingual wall to the restoration, prevent shade-match obstruction and mask staining.', 'armGroupLabels': ['single shade universal resin composite (omnichroma) with blocker', 'single shade universal resin composite(GC solare sculpt) with chameleon effect']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'sarah ahmed, master', 'role': 'CONTACT', 'email': 'sarah.mohamed@dentistry.cu.edu.eg', 'phone': '01015139628'}], 'overallOfficials': [{'name': 'sarah ahmed, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The restorations will be evaluated at T1= after 1 week T2= 3months T3= 6 months T4= 12 months', 'ipdSharing': 'YES', 'description': 'The aim of the study is to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade universal resin composite in class IV restorations over 1year evaluation period.', 'accessCriteria': '* Patients with class IV defects (due to caries lesions, trauma…etc.)\n* Young adult (20 : 40 years old)\n* Good oral hygiene\n* Co-operative patients approving to participate in the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's degree student-faculty of dentistry", 'investigatorFullName': 'sarah ali mohamed ahmed', 'investigatorAffiliation': 'Cairo University'}}}}