Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT06603116
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2024-09-17', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of restorations of class two cavities', 'timeFrame': 'from one week to one year', 'description': 'Measured used FDI criteria'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bioactive Giomer restoration', 'Nano hybrid composite'], 'conditions': ['Dental Restoration Failure']}, 'descriptionModule': {'briefSummary': 'Assess the clinical performance of the bioactive Giomer restoration in class II cavities after one year using FDI criteria for assessment of dental restorations. Moreover, the surface roughness will be investigated in-vitro using profilometer', 'detailedDescription': '* Patients will be selected according to the following inclusion and exclusion criteria from the outpatient Operative clinic, Faculty of Dental Medicine for Girls, Al-Azhar University.\n* The patients will be informed about the purpose of the investigation, the clinical procedures and the advantages/risks of the applied materials and techniques. A written informed consent form will be signed from patients prior to study initiation.\n* Co-operative patients of age range 20-30 years old with no gender prediction, The patients will be divided into two groups Group (1): Bioactive Giomer restoration. Group (2): Nano-hybrid Composite restoration. Restoration will be evaluated using FDI criteria (functional and biological properties) All the restorations will be clinically evaluated after 1 week (baseline),3 month, 6 months,12 months.\n\ndata collected and statistically analyzed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Each patient should have at least two proximal carious lesions on both sides in the posterior teeth.\n\n * Adjacent and opposing natural teeth should be present.\n * Patient should be willing to return for follow-up examination and evaluation.\n\nExclusion Criteria:\n\n* • Patient with poor oral hygiene and motivation.\n\n * Patient with unrealistic expectations.\n * Patients with disabilities, systemic diseases or severe medically compromised, bruxism, clenching or temporomandibular joint disorders and patients with allergy to any components of the materials.'}, 'identificationModule': {'nctId': 'NCT06603116', 'briefTitle': 'Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty of Dental Medicine for Girls'}, 'officialTitle': 'Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year and in Vitro Investigation of the Surface Roughness', 'orgStudyIdInfo': {'id': 'NTaher'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bioactive Giomer restoration.', 'description': 'material applied according to manufacturer instructions. BEAUTIFIL II LS applied directly into the cavity and create the shape desired in layers not exceeding 2 mm and light cured for 20 seconds', 'interventionNames': ['Other: treatment of class two cavities']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nano-hybrid Composite restoration.', 'description': 'applied to the cavity use the conventional incremental technique according to manufacturer instruction', 'interventionNames': ['Other: treatment of class two cavities']}], 'interventions': [{'name': 'treatment of class two cavities', 'type': 'OTHER', 'description': 'restorations in class 2 cavities', 'armGroupLabels': ['Bioactive Giomer restoration.', 'Nano-hybrid Composite restoration.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Maha Niazy, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Dental Medicine for Girls', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer at operative department', 'investigatorFullName': 'Noha Taher', 'investigatorAffiliation': 'Faculty of Dental Medicine for Girls'}}}}