Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT04701320
Status:
UNKNOWN
Last Update Posted:
2021-01-08
First Post:
2020-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer in Treatment of Root Caries in Geriatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C586142', 'term': 'glass carbomer cement'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-08-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-06', 'studyFirstSubmitDate': '2020-07-25', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical restorative performance Service (USHPS)', 'timeFrame': 'Change from the baseline at 3, 6 and12 months', 'description': 'Change in the clinical behavior of the restoration (e.g. anatomical contour, shade match, secondary caries) using modified United State Public Health clinical evaluation assessment method Service (USHPS)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glass Carbomer GCP glass fill root caries Clinical perfomance'], 'conditions': ['Dental Restoration Failure']}, 'descriptionModule': {'briefSummary': 'In geriatric patients, will the clinical performance of nano hydroxyapatite reinforced glass ionomer be better than conventional glass ionomer cement in treatment of root caries lesions over one year follow up?', 'detailedDescription': 'Glass carbomers are commercialized under the name of GCP Glass Fill, this material may be an interesting subject of research, certainly its bioactive properties as the manufacturer claims this material to have remineralizing properties. If this is the case, GCP Glass Fill could be an interesting reference material for further bioactivity studies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • ≥ 50 years old\n\n * Males or females.\n * Community-dwelling\n * Have five or more of their own teeth\n * With ≥ 1 root caries lesion\n\nExclusion Criteria:\n\n* • Patients younger than 50 years old\n\n * Disabilities.\n * Systemic diseases or severe medically compromised.'}, 'identificationModule': {'nctId': 'NCT04701320', 'briefTitle': 'Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer in Treatment of Root Caries in Geriatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer Versus Conventional Glass Ionomer in Treatment of Root Caries in Geriatric Patients: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'OPER 3-3-6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glass carbomer', 'description': 'Nano hydroxyapatite Reinforced Glass Ionomer that results in chemical bond formation with tooth structure mimic that of enamel tissue', 'interventionNames': ['Drug: Nano hydroxyapatite reinforced glass ionomer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fuji ix', 'description': 'Conventional Glass Ionomer cement fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics, a wear resistant, self-adhesive', 'interventionNames': ['Drug: Conventional glass ionomer']}], 'interventions': [{'name': 'Conventional glass ionomer', 'type': 'DRUG', 'otherNames': ['Fujiix gc corporation'], 'description': 'Conventional glass ionomer with enhanced mechanical and esthetic proberties', 'armGroupLabels': ['Fuji ix']}, {'name': 'Nano hydroxyapatite reinforced glass ionomer', 'type': 'DRUG', 'otherNames': ['Glass carbomer'], 'description': 'Nanohydroxyapatite reinforced glass ionomer restorative material with enhanced mechanical proberties and chemical adhesion to tooth structure', 'armGroupLabels': ['Glass carbomer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'one year', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate lecturer', 'investigatorFullName': 'Reham nabil mahmoud', 'investigatorAffiliation': 'Cairo University'}}}}