Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-01 @ 11:37 PM
Study NCT ID:
NCT05470959
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2022-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioactive Composite Versus Resin-Modified Glass Ionomer Liners: 2-Year Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2022-07-19', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess clinical performance of bioactive ionic resin composite and resin-modified glass ionomer liner by using FDI clinical criteria', 'timeFrame': '2-years', 'description': 'comparison of 2-year clinical performance of recent bioactive ionic resin composite( ACTIVA bioactive) to resin-modified glass ionomer liner ( Riva LC) in indirect dental pulp treatment using FDI world dental federation clinical criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries']}, 'referencesModule': {'references': [{'pmid': '38418863', 'type': 'DERIVED', 'citation': 'Ahmed B, Wafaie RA, Hamama HH, Mahmoud SH. 3-year randomized clinical trial to evaluate the performance of posterior composite restorations lined with ion-releasing materials. Sci Rep. 2024 Feb 28;14(1):4942. doi: 10.1038/s41598-024-55329-6.'}]}, 'descriptionModule': {'briefSummary': 'compare 2-year clinical performance of recent bioactive ionic resin composite to resin-modified glass ionomer liner in indirect dental pulp treatment.', 'detailedDescription': "patients were enrolled in the clinical trial. Each patient had two deep carious lesions, one on each side of the mouth. After selective caries removal, cavities were lined with bioactive ionic resin composite (Activa Bioactive Liner/Base) or resin-modified glass ionomer liner (Riva Light Cure RMGI). All cavities were then restored with nanofilled resin composite (Filtek Z350xt). All materials were placed according to the manufacturers' instructions. Clinical evaluation was accomplished using World Dental Federation (FDI) criteria at baseline and after 6 months, one year, one and half years, and two years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of two deep carious lesions, one on each side of the mouth (ICDAS 5 or 6)\n* vital teeth\n* no sensitivity to teeth percussion\n* no spontaneous pain\n* no radiolucency in the periapical or furcation area of teeth\n* complete and normal occlusion\n* good oral hygiene\n\nExclusion Criteria:\n\n* poor oral hygiene\n* severe or chronic periodontal problems\n* periapical lesions\n* heavy bruxism\n* non-vital teeth\n* visibly cracked teeth\n* spontaneous dental pain\n* sensitivity to teeth percussion'}, 'identificationModule': {'nctId': 'NCT05470959', 'acronym': 'BIRCRMGILYCT', 'briefTitle': 'Bioactive Composite Versus Resin-Modified Glass Ionomer Liners: 2-Year Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Bioactive Ionic Resin Composite Versus Resin-Modified Glass Ionomer Cavity Liners: 2-Year Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'M19091019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ACTIVA bioactive', 'description': 'bioactive ionic resin composite', 'interventionNames': ['Other: ACTIVA bioactive']}, {'type': 'OTHER', 'label': 'Riva LC', 'description': 'Resin-modifed glass ionomer', 'interventionNames': ['Other: Riva LC']}], 'interventions': [{'name': 'ACTIVA bioactive', 'type': 'OTHER', 'description': 'bioactive ionic resin composite', 'armGroupLabels': ['ACTIVA bioactive']}, {'name': 'Riva LC', 'type': 'OTHER', 'otherNames': ['Riva light cure'], 'description': 'resin-modified glass ionomer', 'armGroupLabels': ['Riva LC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'salah mahmoud, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of dentistry, mansoura university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}