Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT04272112
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2020-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-06', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical perfomance', 'timeFrame': '12 month', 'description': 'To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.'}, {'measure': 'Clinical perfomance', 'timeFrame': '24 month', 'description': 'To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.'}, {'measure': 'Clinical perfomance', 'timeFrame': '36 month', 'description': 'To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.'}, {'measure': 'Clinical perfomance', 'timeFrame': '60 month', 'description': 'To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.'}], 'secondaryOutcomes': [{'measure': 'Patient questionnaire', 'timeFrame': '12 month', 'description': "Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied')."}, {'measure': 'Patient questionnaire', 'timeFrame': '24 month', 'description': "Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied')."}, {'measure': 'Patient questionnaire', 'timeFrame': '36 month', 'description': "Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied')."}, {'measure': 'Patient questionnaire', 'timeFrame': '60 month', 'description': "Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied')."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['all ceramic', 'zirconia', 'crown', 'clinal trial'], 'conditions': ['Dental Prosthesis Failure']}, 'referencesModule': {'references': [{'pmid': '25580846', 'type': 'BACKGROUND', 'citation': 'Le M, Papia E, Larsson C. The clinical success of tooth- and implant-supported zirconia-based fixed dental prostheses. A systematic review. J Oral Rehabil. 2015 Jun;42(6):467-80. doi: 10.1111/joor.12272. Epub 2015 Jan 10.'}, {'pmid': '31105161', 'type': 'BACKGROUND', 'citation': 'LE M, Larsson C, Papia E. Bond strength between MDP-based cement and translucent zirconia. Dent Mater J. 2019 Jun 1;38(3):480-489. doi: 10.4012/dmj.2018-194. Epub 2019 May 17.'}, {'pmid': '24392475', 'type': 'BACKGROUND', 'citation': 'Larsson C, Wennerberg A. The clinical success of zirconia-based crowns: a systematic review. Int J Prosthodont. 2014 Jan-Feb;27(1):33-43. doi: 10.11607/ijp.3647.'}, {'pmid': '23865549', 'type': 'BACKGROUND', 'citation': 'Johansson C, Kmet G, Rivera J, Larsson C, Vult Von Steyern P. Fracture strength of monolithic all-ceramic crowns made of high translucent yttrium oxide-stabilized zirconium dioxide compared to porcelain-veneered crowns and lithium disilicate crowns. Acta Odontol Scand. 2014 Feb;72(2):145-53. doi: 10.3109/00016357.2013.822098. Epub 2013 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, prospective clinical trial. The aim of the project is to assess the clinical performance of three types of tooth-supported crowns; monolithic high translucent colored zirconia, crowns of high-translucent colored zirconia with a mini-veneer buccally and crowns of lithium-disilicate glass-ceramic. Crowns will be placed on posterior teeth and evaluated from an esthetic and functional point of view, to identify if there are any differences between the materials.', 'detailedDescription': '90 monolithic tooth-supported crowns are planned to be included in the study; 30 crowns of high translucent zirconia (BruxZir, Glidewell), 30 crowns of high translucent zirconia (BruxZir, Glidewell) with a mini-veneer of porcelain and 30 crowns of lithium-disilicate glass-ceramic (IPS e.max CAD, Ivoclar Vivadent AG, Schaan, Liechtenstein).\n\nPatients with indications for single crowns will be recruited from three general dental clinics. Inclusion criteria for participating in this study are patients in need of crowns in the posterior dentition, premolars and molars. Exclusion criteria are patients with high caries activity/risk for caries and/or advanced periodontal disease. Patients who meet the criteria will be offered the opportunity to participate in the study. They will receive written information about the study design, clinical procedures and the materials and methods to be used. Patients who are interested will confirm their participation by a written consent. The patients will be offered an extended warranty for the crowns in case of failure.\n\nThe study has been approved by the Regional Ethical Board in Lund, Sweden'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* need of one or more dental crowns in the posterior dentition, premolars and molars\n\nExclusion criteria:\n\n* high caries activity/risk for caries and/or advanced periodontal disease'}, 'identificationModule': {'nctId': 'NCT04272112', 'briefTitle': 'Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.', 'organization': {'class': 'OTHER', 'fullName': 'Malmö University'}, 'officialTitle': 'Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical Trial Comparing Glass-ceramic Crowns to Monolithic Translucent Zirconia Crowns With and Without a Semi-veneer', 'orgStudyIdInfo': {'id': 'NN1401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glass-ceramic', 'description': '30 dental crowns of lithium-disilicate glass-ceramic', 'interventionNames': ['Combination Product: BruxZir, Glidewell', 'Combination Product: BruxZir*, Glidewell']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zirconia', 'description': '30 dental crowns of high translucent zirconia', 'interventionNames': ['Combination Product: IPS e.max CAD, Ivoclar Vivadent', 'Combination Product: BruxZir*, Glidewell']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zirconia with mini-veneer', 'description': '30 dental crowns of high translucent zirconia with a mini-veneer of porcelain', 'interventionNames': ['Combination Product: IPS e.max CAD, Ivoclar Vivadent', 'Combination Product: BruxZir, Glidewell']}], 'interventions': [{'name': 'IPS e.max CAD, Ivoclar Vivadent', 'type': 'COMBINATION_PRODUCT', 'description': 'Type: monolithic lithium-disilicate glass ceramic', 'armGroupLabels': ['Zirconia', 'Zirconia with mini-veneer']}, {'name': 'BruxZir, Glidewell', 'type': 'COMBINATION_PRODUCT', 'description': 'Type: high translucent zirconia', 'armGroupLabels': ['Glass-ceramic', 'Zirconia with mini-veneer']}, {'name': 'BruxZir*, Glidewell', 'type': 'COMBINATION_PRODUCT', 'description': 'Type: high translucent zirconia with a mini-veneer of porcelain', 'armGroupLabels': ['Glass-ceramic', 'Zirconia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Malmo', 'country': 'Sweden', 'facility': 'Malmö University', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Christel Larsson, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Malmö University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malmö University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal investigator', 'investigatorFullName': 'Minh Le', 'investigatorAffiliation': 'Malmö University'}}}}