Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-03-03 @ 11:50 PM
Study NCT ID:
NCT02943395
Status:
UNKNOWN
Last Update Posted:
2016-10-24
First Post:
2016-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-21', 'studyFirstSubmitDate': '2016-10-19', 'studyFirstSubmitQcDate': '2016-10-21', 'lastUpdatePostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Color stability assessed clinically using easy shade vita device', 'timeFrame': '1 Year', 'description': 'Color stability'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction assessed using a Questionnaire', 'timeFrame': '1 Year', 'description': 'Questionnaire for the patient satisfaction'}]}, 'conditionsModule': {'conditions': ['Tooth Discoloration']}, 'referencesModule': {'references': [{'pmid': '24118675', 'type': 'BACKGROUND', 'citation': 'Magalhaes AP, Cardoso Pde C, de Souza JB, Fonseca RB, Pires-de-Souza Fde C, Lopez LG. Influence of activation mode of resin cement on the shade of porcelain veneers. J Prosthodont. 2014 Jun;23(4):291-5. doi: 10.1111/jopr.12098. Epub 2013 Oct 7.'}, {'pmid': '22821429', 'type': 'BACKGROUND', 'citation': 'Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'Light curing cements used for laminate veneers may be not totally cured in certain areas, so dual cured resin cements may solve this problem yet the dual cured cements containing amines cause yellowish discoloration of the veneers after time.\n\nA new dual cured cement which is amine free is introduced so the investigators have to try it clinically using parallel groups in randomized clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects are required to be:\n\n* From 18-60 years old, and able to read and sign the informed consent document\n* physically and psychologically able to tolerate conventional restorative procedures\n* Have no active periodontal or pulpal diseases, have teeth with good restorations\n* Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….)\n* Willing to return for follow-up examinations and evaluation\n\nExclusion Criteria:\n\n* Patients in the growth stage with partially erupted teeth\n* Patient with fractured teeth of more than 50% enamel loss\n* Patients with poor oral hygiene and motivation\n* Pregnant women\n* Psychiatric problems or unrealistic expectations\n* Lack of opposite occluding dentition in the area intended for restoration'}, 'identificationModule': {'nctId': 'NCT02943395', 'briefTitle': 'Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'orgStudyIdInfo': {'id': '17191405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dual cure amine free adhesive resin cement', 'description': 'resin cement that get activated by both light and chemicals', 'interventionNames': ['Other: E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'light cured adhesive resin cement', 'description': 'resin cement that only get activated by light', 'interventionNames': ['Other: E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement']}], 'interventions': [{'name': 'E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement', 'type': 'OTHER', 'armGroupLabels': ['dual cure amine free adhesive resin cement']}, {'name': 'E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement', 'type': 'OTHER', 'armGroupLabels': ['light cured adhesive resin cement']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mahmoud Elkomy, B.D.s', 'role': 'CONTACT', 'email': 'mahmoud.hossam919@gmail.com', 'phone': '01113735370'}, {'name': 'Jylan elguindy', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dentist at egyption ministry of health', 'investigatorFullName': 'mahmoud hossam eldin elkomy', 'investigatorAffiliation': 'Cairo University'}}}}