Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 7:14 PM
Study NCT ID:
NCT06166160
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2023-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-03', 'studyFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2023-12-03', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical performance', 'timeFrame': 'one-year', 'description': 'The difference in the clinical performance flowable bulk fill composite SDR® flow+ and and high viscous glass-ionomer cement(EQUIA Forte) In Class II cavities in primary molars using FDI criteria'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bulk-fill flowable composite , high viscous GIC ,'], 'conditions': ['Management of Dental Caries of Primary Molars']}, 'descriptionModule': {'briefSummary': 'the study was conducted to compare and evaluate the clinical performance of EQUIA Forte and SDR® flow+ in class II cavities in primary molar', 'detailedDescription': "Initial intra-oral periapical bitewing radiographs of the teeth to be treated were taken before the procedure. After obtaining partial isolation using cotton rolls and saliva ejector, caries excavation and removal of undermined enamel will be done using high-speed diamond burs with water cooling and hand instruments. After finishing the cavity, a matrix band will be placed with the interproximal wedge. The prepared cavities will be restored using Equia Forte or flowable bulk-fill composite resin according to the manufacturer's instructions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 4 to 8 years old medically free children.\n2. Cooperative children are classified as class 3 or 4 based on Frankel et al. classification.\n3. Children who had at least one active dentinal carious lesion on the proximal surface of primary molars\n\nExclusion Criteria:\n\n1. Refusal of the parents to sign the informed consent\n2. Presence of deep bite or any pictures of malocclusion and parafunctional habits.'}, 'identificationModule': {'nctId': 'NCT06166160', 'briefTitle': 'Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Restoring Class II Cavities of Primary Molars: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'PED22-3D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SDR FLOW + bulk fill flowable', 'description': 'in class II cavities of primary molars', 'interventionNames': ['Other: Bulk fill flowable composite SDR Dentsply sirona']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high-viscosity glass ionomer cement (EQUIA Forte)', 'description': 'in class II cavities of primary molars', 'interventionNames': ['Other: Bulk fill flowable composite SDR Dentsply sirona']}], 'interventions': [{'name': 'Bulk fill flowable composite SDR Dentsply sirona', 'type': 'OTHER', 'otherNames': ['high viscosity glass ionomer cement (EQUIA Forte HT) GC'], 'description': 'caries removal in class II cavities of primary molars and application of experminted restorations', 'armGroupLabels': ['SDR FLOW + bulk fill flowable', 'high-viscosity glass ionomer cement (EQUIA Forte)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Marina F assistant lecturer', 'role': 'CONTACT'}], 'facility': 'Faculty of dentistry .Ain shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Marina F assistant lecturer', 'role': 'CONTACT'}], 'facility': 'Marina Fakhry Fahmy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Marina F Fahmy, MD', 'role': 'CONTACT', 'email': 'Dr.marina.fakhry@gmail.com', 'phone': '01273731722'}], 'overallOfficials': [{'name': 'Marina F Fahmy, ass.lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assistant lecturer of pediatric dentistry ,faculty of dentistry ASU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'study protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of pdiateric dentistry and dental public health ,faculty of dentistry', 'investigatorFullName': 'Marina F Fahmy, MD', 'investigatorAffiliation': 'Ain Shams University'}}}}