Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-03 @ 9:00 AM
Study NCT ID:
NCT04298151
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2020-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of Zirconia Reinforced GI Versus Conventional Viscous GI in Geriatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance', 'timeFrame': '1 year', 'description': 'clinical performance of the Glass Ionomer restorations using modified USPHS criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glass ionomer', 'Restorations'], 'conditions': ['Geriatric', 'Performance']}, 'referencesModule': {'references': [{'pmid': '27156000', 'type': 'BACKGROUND', 'citation': 'Klinke T, Daboul A, Turek A, Frankenberger R, Hickel R, Biffar R. Clinical performance during 48 months of two current glass ionomer restorative systems with coatings: a randomized clinical trial in the field. Trials. 2016 May 8;17(1):239. doi: 10.1186/s13063-016-1339-8.'}, {'pmid': '27461814', 'type': 'BACKGROUND', 'citation': 'Walia R, Jasuja P, Verma KG, Juneja S, Mathur A, Ahuja L. A comparative evaluation of microleakage and compressive strength of Ketac Molar, Giomer, Zirconomer, and Ceram-x: An in vitro study. J Indian Soc Pedod Prev Dent. 2016 Jul-Sep;34(3):280-4. doi: 10.4103/0970-4388.186746.'}, {'pmid': '30034008', 'type': 'BACKGROUND', 'citation': 'Albeshti R, Shahid S. Evaluation of Microleakage in Zirconomer(R): A Zirconia Reinforced Glass Ionomer Cement. Acta Stomatol Croat. 2018 Jun;52(2):97-104. doi: 10.15644/asc52/2/2.'}, {'pmid': '29663908', 'type': 'BACKGROUND', 'citation': 'de Franca Lopes CMC, Schubert EW, Martins AS, Loguercio AD, Reis A, Chibinski ACR, Wambier DS. Randomized Clinical Trial of ART Class II Restorations Using Two Glass Ionomer Cements: One-Year Follow-Up. Pediatr Dent. 2018 Mar 15;40(2):98-104.'}, {'pmid': '21840585', 'type': 'BACKGROUND', 'citation': 'Friedl K, Hiller KA, Friedl KH. Clinical performance of a new glass ionomer based restoration system: a retrospective cohort study. Dent Mater. 2011 Oct;27(10):1031-7. doi: 10.1016/j.dental.2011.07.004. Epub 2011 Aug 15.'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted to evaluate the clinical performance of Zirconomer Improved GI restoration compared to Conventional viscous GI restoration in geriatric patients with Posterior carious lesions in class I or II cavities', 'detailedDescription': 'This study will be conducted to determine the clinical performance of the Zirconia reinforced glass ionomer restorations ( Zirconomer improved) under stress bearing posterior area (class I or claa II cavities) in geriatric population in comparison to Conventional viscous glass ionomer restorations (Ketac molar quick Aplicap) using the modified United States Public Health Service (USPHS) criteria\n\nP: Geriatric Patients with posterior Caries lesions I: Zirconia reinforced GI (Zirconomer Improved) C: Conventional viscous GI, (Ketac Molar quick Aplicap) O: The Clinical performance of the Glass Ionomer restorations Using USPHS Criteria'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range 60-80 years\n* Geriatric patients with Class I or II Posterior carious lesions.\n* Males or Females.\n* Pulp asymptomatic vital carious posterior teeth.\n* Co-operative patients approving to participate in the trial.\n\nExclusion Criteria:\n\n* Age range less than 60 years.\n* Disabilities.\n* Deep extensive carious cavities that may lead to fracture of the tooth or pulpal affection.\n* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.\n* Heavy smoking.\n* Lack of compliance.'}, 'identificationModule': {'nctId': 'NCT04298151', 'briefTitle': 'Clinical Performance of Zirconia Reinforced GI Versus Conventional Viscous GI in Geriatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Evaluation of Zirconia Reinforced Versus Conventional Viscous Glass Ionomer in Posterior Restorations of Geriatric Patients: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Zirconia GI Conventional GI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zirconomer improved', 'description': 'zirconia reinforced glass ionomer restoration', 'interventionNames': ['Drug: Zirconomer Improved']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ketac molar quick aplicap', 'description': 'conventional viscous glass ionomer restoration', 'interventionNames': ['Drug: Ketac Molar quick Aplicap']}], 'interventions': [{'name': 'Zirconomer Improved', 'type': 'DRUG', 'otherNames': ['zirconia reinforced GI'], 'description': 'glass ionomer restoration reinforced with nano-zirconia particles to improve strength and esthetics', 'armGroupLabels': ['zirconomer improved']}, {'name': 'Ketac Molar quick Aplicap', 'type': 'DRUG', 'otherNames': ['KMQ aplicap'], 'description': 'highly viscous glass ionomer with improved mechanical properties than the conventional GI', 'armGroupLabels': ['ketac molar quick aplicap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12573', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Doaa Abdou', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Doaa Mohammed Mohammed Abdou', 'investigatorAffiliation': 'Cairo University'}}}}