Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT05049694
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Success of Zirconia and Stainless Steel Crowns for Permanent Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of zirconia and stainless steel crowns that showed successful retention over two years', 'timeFrame': '2 years', 'description': 'Long-term clinical success of zirconia and stainless steel crowns placed on permanent molars'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['zirconia crowns', 'stainless steel crowns', 'dental caries'], 'conditions': ['Caries Active', 'Dentin, Carious']}, 'referencesModule': {'references': [{'pmid': '37924021', 'type': 'DERIVED', 'citation': 'Geduk N, Ozdemir M, Erbas Unverdi G, Ballikaya E, Cehreli ZC. Clinical and radiographic performance of preformed zirconia crowns and stainless-steel crowns in permanent first molars: 18-month results of a prospective, randomized trial. BMC Oral Health. 2023 Nov 3;23(1):828. doi: 10.1186/s12903-023-03501-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and stainless steel crowns on permanent molar', 'detailedDescription': "Zirconia and stainless steel crowns will be placed on at least two permanent molars, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into two groups according to the crown type.\n\nGroup 1: Zirconia crown 2: Stainless steel crown. Plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos will be taken directly after treatment and at control appointments.\n\nThe data will be analysed statistically using Fisher's Exact Test and pearson's chi-square test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients and parent of the patients who accept to participate and sign the informed consent\n* Patients who have at least two permanent molars with caries that require crown restoration\n* Patients that have good cooperation to the procedure\n\nExclusion Criteria:\n\n* Patients and parent of the patients who don't accept to participate and sign the informed consent\n* Teeth that doesn't have opposing permanent molars\n* Patients who have bruxism or deep-bite\n* Patient who are allergic to nickel"}, 'identificationModule': {'nctId': 'NCT05049694', 'briefTitle': 'Success of Zirconia and Stainless Steel Crowns for Permanent Molars', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Clinical and Radiographic Performance of Preformed Zirconia Crowns and Stainless-Steel Crowns in Permanent First Molars: 18-Month Results of a Prospective, Randomized Trial', 'orgStudyIdInfo': {'id': 'posterior permanent crown rest'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zirconia crowns', 'description': 'esthetic crowns for capping permanent molars with caries', 'interventionNames': ['Device: zirconia crowns']}, {'type': 'EXPERIMENTAL', 'label': 'stainless steel crowns', 'description': 'stainless steel crowns for capping permanent molars with caries', 'interventionNames': ['Device: stainless steel crowns']}], 'interventions': [{'name': 'zirconia crowns', 'type': 'DEVICE', 'description': 'esthetic crowns for capping permanent molars with caries', 'armGroupLabels': ['zirconia crowns']}, {'name': 'stainless steel crowns', 'type': 'DEVICE', 'description': 'stainless steel crowns for capping permanent molars with caries', 'armGroupLabels': ['stainless steel crowns']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr.', 'investigatorFullName': 'Zafer Cavit Cehreli, DDS, PhD', 'investigatorAffiliation': 'Hacettepe University'}}}}