Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-04-02 @ 5:37 AM
Study NCT ID:
NCT02856932
Status:
UNKNOWN
Last Update Posted:
2016-08-05
First Post:
2016-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C015897', 'term': 'glass ionomer'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 31}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2016-08-01', 'studyFirstSubmitQcDate': '2016-08-02', 'lastUpdatePostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance using FDI criteria for dental restorations (functional properties and biological properties)', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Class I Cavities in High Caries Risk']}, 'descriptionModule': {'briefSummary': 'PICOTS:\n\nP: High Caries Risk Patients with bilateral class I cavities. I: Glass Ionomer with Glass Hybrid Technology. C: Conventional High Viscosity Glass Ionomer. O: Clinical performance (Functional properties Biological properties) using (World Dental Federation) Fédération dentaire internationale (FDI) criteria for dental restorations.\n\nT: 1 year. S: Randomized controlled Trial (split mouth design). Research question:In high caries risk patients with class I cavities will glass ionomer with glass hybrid technology has similar clinical performance as conventional high viscosity glass ionomer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral class I carious lesions in their occlusal pits and fissures.\n* High caries risk patients who has 1 or more cavitated lesion with risk factor declared by Caries Management By Risk Assessment (CAMBRA)\n* Co-operative patients approving to participate in the trial.\n\nExclusion Criteria:\n\n* Disabilities.\n* Systemic diseases or severe medically compromised.\n* Lack of compliance.\n* Evidence of severe bruxism, clenching or temporomandibular joint disorders'}, 'identificationModule': {'nctId': 'NCT02856932', 'briefTitle': 'Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CEBD-CU-2016-08-178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glass Ionomer with Glass Hybrid technology', 'description': 'Intervention', 'interventionNames': ['Other: Glass ionomer with glass hybrid technology']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional high viscosity Glass Ionomer', 'description': 'Comparator', 'interventionNames': ['Other: Conventional high viscosity glass ionomer']}], 'interventions': [{'name': 'Conventional high viscosity glass ionomer', 'type': 'OTHER', 'otherNames': ['GC EQUIA'], 'description': 'Dental restorative material', 'armGroupLabels': ['Conventional high viscosity Glass Ionomer']}, {'name': 'Glass ionomer with glass hybrid technology', 'type': 'OTHER', 'otherNames': ['GC EQUIA Forte'], 'description': 'Dental restorative material', 'armGroupLabels': ['Glass Ionomer with Glass Hybrid technology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Amira F El-Zoghby, Professor', 'role': 'CONTACT', 'email': 'Amfzh52@yahoo.com', 'phone': '+201222106620'}, {'name': 'Ahmed A El-Zohairy, Associate professor', 'role': 'CONTACT', 'email': 'Aelzohairy@gmail.com', 'phone': '+201227848002'}], 'facility': 'Faculty of oral and dental medicine, cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed R El-Bialy, Assistant lecturer', 'role': 'CONTACT', 'email': 'M.refaat.op@gmail.com', 'phone': '+201202552666'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Mohamed Refaat El-Bialy', 'investigatorAffiliation': 'Cairo University'}}}}