Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-28 @ 6:36 AM
Study NCT ID:
NCT04557657
Status:
UNKNOWN
Last Update Posted:
2021-01-28
First Post:
2020-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Marginal Integrity Using Bioactive Cement Incementation of Indirect Composite Blocks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019279', 'term': 'Resin Cements'}], 'ancestors': [{'id': 'D012117', 'term': 'Resins, Synthetic'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D003738', 'term': 'Dental Cements'}, {'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '36 volunteer assigned randomly into 2 equal groups of 18'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal Discoloration', 'timeFrame': '12 Months', 'description': 'Check Marginal Discoloration Using Modified USPH criteria'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Composite blocks', 'Cad/Cam', 'Cerec'], 'conditions': ['Resin Cement']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate of marginal integrity of indirect composite restoration after cementation by a bioactive cement in comparison to dual cure resin cement using Modified USPHS criteria', 'detailedDescription': 'The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University, The operator in charge will be: Mohamed Sherif . The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to them,A total of 36 volunteer patients with Patients with badly broken vital teeth with minimum of two remaining walls. Patients will be randomly divided into two groups according to type of cement (S) where in group S1, Restoration will be cemented with resin cement ; while group S2,Restoration will be cemented with active cement. Each restoration will be assessed after three, six months and one year using modified USPH Criteria Marginal Discoloration, Recurrent Caries and Marginal Chipping with scale of Alpha and non alpha'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with badly broken vital teeth with minimum of two remaining walls\n* Adult Males or female 16- 65 years old\n* Good oral hygiene measures with a good gingival condition\n* Cooperative patients approving to participate in the study\n* Free of any medical condition that interfere with procedures\n\nExclusion Criteria:\n\n* Patients with a compromised medical history.\n* Severe or active periodontal disease\n* Endodontically treated teeth\n* Severe medical complications Lack of compliance'}, 'identificationModule': {'nctId': 'NCT04557657', 'briefTitle': 'Evaluation of Marginal Integrity Using Bioactive Cement Incementation of Indirect Composite Blocks', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Marginal Integrity Using Modified USPHS Criteria of a Bioactive Cement in Comparison to Resin Cement in Cementation of Indirect Composite Blocks: A Randomized Clinical Trial 12 Month Follow up', 'orgStudyIdInfo': {'id': 'CEBD-CU-2019-07-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control Group Resin cement', 'description': 'Control group Using resin cement', 'interventionNames': ['Drug: Resin Cement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group Active Cement', 'description': 'Intervention Group Using active cement bio activa', 'interventionNames': ['Drug: Active bio Activa']}], 'interventions': [{'name': 'Active bio Activa', 'type': 'DRUG', 'otherNames': ['Active Cement Pulpodent'], 'description': 'Cement that release fluoride', 'armGroupLabels': ['Intervention Group Active Cement']}, {'name': 'Resin Cement', 'type': 'DRUG', 'description': 'Resin Cement Convinonal', 'armGroupLabels': ['Control Group Resin cement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12566', 'city': 'Cairo', 'state': 'EL Manial', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1 Year', 'ipdSharing': 'YES', 'description': 'Individual patient Data can be shared Upon request', 'accessCriteria': 'Mail'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Mohamed Sherif', 'investigatorAffiliation': 'Cairo University'}}}}