Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT04274920
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2020-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dentin Bridge Formation After Indirect Pulp Capping With Bioactive Glass Incorporated in Resin Composite and Its Adhesive in Comparison With Light Cured Calcium Hydroxide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-17', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of dentine thickness', 'timeFrame': 'baseline, one month, 3 months and 6 months', 'description': 'Thickness in millimeters using CBCT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulp Disease, Dental', 'Dental Caries']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of application of bioactive glass in different protocols on the formation of dentin bridge after indirect pulp capping using resin composite with its adhesive both are containing bioactive glass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active carious lesion in deep dentin of molars.\n* Absence of cavitated lesions at the buccal or lingual surfaces as determined by clinical and radiographic examination.\n* Absence of clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues, and abnormal tooth mobility;\n* Absence of clinical symptoms of irreversible pulpitis, such as spontaneous pain or sensitivity to pressure;\n* The extension of the carious lesion should be such that complete caries removal would risk pulp exposure, as determined by clinical and radiographic assessment;\n* Absence of radiolucencies at the interradicular or periapical regions, or thickening of the periodontal spaces, that would indicate the presence of irreversible pulp pathologies or necrosis;\n* Absence of internal or external root resorption.\n* Co-operative patients approving the trial.\n\nExclusion Criteria:\n\n* Patients with systemic medical conditions\n* pregnant females\n* Teeth with spontaneous pain or sensitivity to percussion.\n* Teeth with periodontal lesions, internal or external root resorption, mobility of tooth, sinus opening, or abscessed tooth.\n* Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.'}, 'identificationModule': {'nctId': 'NCT04274920', 'briefTitle': 'Dentin Bridge Formation After Indirect Pulp Capping With Bioactive Glass Incorporated in Resin Composite and Its Adhesive in Comparison With Light Cured Calcium Hydroxide', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Clinical Response of Human Pulps Capped With Bioactive Glass Incorporated in Resin Composite and Adhesive', 'orgStudyIdInfo': {'id': 'REC16-071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bioactive Glass', 'description': "18 teeth were capped indirectly with dental adhesive containing bioactive glass applied according to the manufacturer's instructions and cured for 20 seconds and then resin composite restoration containing bioactive glass applied by golden plated composite applicator in increments 2 mm each and cured for 40 seconds for each increment.", 'interventionNames': ['Other: Bioactive Glass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Light cured calcium hydroxide', 'description': "18 teeth were capped indirectly with light cured calcium hydroxide (control group) applied according to the manufacturer's instructions by calcium hydroxide applicator and light cured for 20 seconds then resin composite restoration was applied by golden plated composite applicator in increments 2 mm each and cured for 40 seconds for each increment.", 'interventionNames': ['Other: Light cured calcium hydroxide']}], 'interventions': [{'name': 'Bioactive Glass', 'type': 'OTHER', 'description': 'Bioactive glass was incorporated in resin composite and its adhesive', 'armGroupLabels': ['Bioactive Glass']}, {'name': 'Light cured calcium hydroxide', 'type': 'OTHER', 'description': 'Light cured calcium hydroxide', 'armGroupLabels': ['Light cured calcium hydroxide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'AlAzhar University, Faculty of Dentistry for Girls', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Heba Arafa Abd El wahab Zahran', 'investigatorAffiliation': 'Al-Azhar University'}}}}