Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT04995458
Status:
UNKNOWN
Last Update Posted:
2023-01-25
First Post:
2021-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Composite-ceramic Implant-supported Posterior Crowns (Cerasmart)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-22', 'studyFirstSubmitDate': '2021-08-02', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of restorations at baseline', 'timeFrame': 'Baseline', 'description': "The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement)."}, {'measure': 'Quality of restorations at 1 year', 'timeFrame': '1 year', 'description': "The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement)."}, {'measure': 'Quality of restorations at 2 year', 'timeFrame': '2 years', 'description': "The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement)."}, {'measure': 'Quality of restorations at 3 year', 'timeFrame': '3 years', 'description': "The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement)."}, {'measure': 'Plaque Index (PI) at baseline', 'timeFrame': 'baseline', 'description': 'Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.'}, {'measure': 'Plaque Index (PI) at 1 year', 'timeFrame': '1 year', 'description': 'Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.'}, {'measure': 'Plaque Index (PI) at 2 years', 'timeFrame': '2 years', 'description': 'Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.'}, {'measure': 'Plaque Index (PI) at 3 years', 'timeFrame': '3 years', 'description': 'Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.'}, {'measure': 'Gingival Index (GI) at baseline', 'timeFrame': 'Baseline', 'description': 'Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.'}, {'measure': 'Gingival Index (GI) at 1 year', 'timeFrame': '1 year', 'description': 'Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.'}, {'measure': 'Gingival Index (GI) at 2 years', 'timeFrame': '2 years', 'description': 'Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.'}, {'measure': 'Gingival Index (GI) at 3 years', 'timeFrame': '3 years', 'description': 'Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.'}, {'measure': 'Probing depth at baseline', 'timeFrame': 'Baseline', 'description': 'Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome'}, {'measure': 'Probing depth at 1 year', 'timeFrame': '1 year', 'description': 'Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome'}, {'measure': 'Probing depth at 2 year', 'timeFrame': '2 years', 'description': 'Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome'}, {'measure': 'Probing depth at 3 year', 'timeFrame': '3 years', 'description': 'Probing depth of the abutment teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implant-supported crowns', 'monolithic zirconia', 'composite-ceramic', 'clinical evaluation', 'survival'], 'conditions': ['Dental Materials']}, 'descriptionModule': {'briefSummary': 'The objectives of the present study are to analyze and to compare the survival rates and possible biological and technical complications arising from the use of composite-ceramic posterior implant-supported crowns with those obtained when using their counterparts prepared using monolithic zirconia restorations. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.', 'detailedDescription': 'Eighty patients in need of posterior implant-supported crowns (n=80) were recruited from the Master of Buccofacial Prostheses and Occlusion, Faculty of Odontology, University Complutense of Madrid, Madrid, Spain. Before treatment, all participants were informed of the purpose of the study, the clinical procedures, the material to be used, and the advantages and risks of the restorations. They were asked to give their written informed consent to participate in the study.\n\nEighty posterior implant-supported crowns were produced and allocated in parallel an randomly to either monolithic zirconia or composite-ceramic restorations by means of a randomization list. A total of 40 implant-supported crowns were placed using monolithic zirconia and 40 composite-ceramic. The clinical procedures were performed by two experienced clinicians. Full-arch impressions were taken using addition silicone. The restorations were cemented using a resin-based cement. The occlusion was adjusted and the surfaces polished after cementing. All restorations were prepared by an experienced technician. The restorations will be examined at one week (baseline), 1, 2, and 3 years by two researchers who were not involved in the restorative treatment. Each assessor evaluated the restoration independently, and the worst assessment will be used in the event of discrepancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One posterior tooth (molar or premolar) to restore, and with opposing tooth\n\nExclusion Criteria:\n\n* unacceptable oral hygiene\n* bruxism'}, 'identificationModule': {'nctId': 'NCT04995458', 'acronym': 'Cerasmart', 'briefTitle': 'Clinical Evaluation of Composite-ceramic Implant-supported Posterior Crowns (Cerasmart)', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Clinical Evaluation of Cerasmart Implant-supported Posterior Crowns', 'orgStudyIdInfo': {'id': 'GC Europe N.V-4156360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Composite-ceramic', 'description': 'To assess the clinical performance and survival of posterior composite-ceramic implant-supported crowns', 'interventionNames': ['Procedure: composite-ceramic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monolithic zirconia', 'description': 'To assess the clinical performance and survival of posterior monolitihic zirconia implant-supported crowns', 'interventionNames': ['Procedure: Monolithic zirconia']}], 'interventions': [{'name': 'composite-ceramic', 'type': 'PROCEDURE', 'otherNames': ['Cerasmart'], 'description': 'To assess the clinical performance of composite-ceramic crowns', 'armGroupLabels': ['Composite-ceramic']}, {'name': 'Monolithic zirconia', 'type': 'PROCEDURE', 'description': 'To assess the clinical performance of monolithic z¡irconia crowns', 'armGroupLabels': ['Monolithic zirconia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Faculty of Odontology', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'MARIA J SUAREZ, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad Complutense de Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'GC Europe', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}