Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT04685967
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2020-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014076', 'term': 'Tooth Diseases'}], 'ancestors': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performances of different restorative systems according to USPHS criteria', 'timeFrame': 'two years', 'description': 'Two year results according to USPHS criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tooth Disease']}, 'descriptionModule': {'briefSummary': "The clinical performance of a restorative glass ionomer and bulk-fill resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a restorative glass ionomer \\[Equia Forte HT, GC, Tokyo, Japan (EHT)\\] and bulk-fill composite resin \\[SonicFill2, Orange, CA, USA (SBF)\\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age range will be 18 to 65\n* patients should have at least 2 approximal caries lesions require restoration\n* healthy periodontal status\n* a good likelihood of recall availability\n\nExclusion Criteria:\n\n* poor gingival health\n* adverse medical history\n* potential behavioral problems'}, 'identificationModule': {'nctId': 'NCT04685967', 'briefTitle': 'Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin', 'orgStudyIdInfo': {'id': 'glass ionomer-bulk fill'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glass-ionomer', 'description': 'Equia Forte HT, GC, Tokyo, Japan (EHT)', 'interventionNames': ['Device: Glass ionomer']}, {'type': 'EXPERIMENTAL', 'label': 'Bulk-Fill', 'description': 'SonicFill2, Orange, CA, USA (SBF)', 'interventionNames': ['Device: Bulk-fill composite']}], 'interventions': [{'name': 'Glass ionomer', 'type': 'DEVICE', 'description': 'Equia Forte HT, GC, Tokyo, Japan', 'armGroupLabels': ['Glass-ionomer']}, {'name': 'Bulk-fill composite', 'type': 'DEVICE', 'description': 'SonicFill2, Orange, CA, USA', 'armGroupLabels': ['Bulk-Fill']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Dr. Fatma Dilşad Öz', 'investigatorAffiliation': 'Hacettepe University'}}}}