Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-09 @ 5:31 AM
Study NCT ID:
NCT04281433
Status:
COMPLETED
Last Update Posted:
2020-02-24
First Post:
2020-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner
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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electromyographic activity', 'timeFrame': 'baseline (immediate)', 'description': 'An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement'}, {'measure': 'Electromyographic activity', 'timeFrame': 'one week', 'description': 'An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement'}, {'measure': 'Electromyographic activity', 'timeFrame': 'after three months', 'description': 'An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement'}, {'measure': 'Electromyographic activity', 'timeFrame': 'after six months', 'description': 'An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement'}], 'secondaryOutcomes': [{'measure': 'Survival rate of restorative material', 'timeFrame': 'six months', 'description': 'USPHS criteria'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Study of Activa Bioactive Restorative', 'Dental Caries']}, 'descriptionModule': {'briefSummary': 'electromyographic activity as well as clinical performance of bulk-Fill composite resins with Activa Bioactive Liner'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 18-40 years and cooperative patient.\n* Good oral hygiene.\n* Normal occlusal relation with normal dentition.\n\nExclusion Criteria:\n\n* Patient with severe medical problems.\n* Tenderness with percussion or pre-operative pulpal pain.\n* Mobile tooth and tooth with gingival recession.\n* Pregnant or lactating females.\n* Cracked teeth or teeth with deep periodontal pockets.\n* Tooth with previous restoration.\n* Allergy to resin materials.\n* Defective restorations adjacent or opposing to tooth.\n* Patient with bruxism'}, 'identificationModule': {'nctId': 'NCT04281433', 'briefTitle': 'Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Electromicrographic Activity as Well as Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner', 'orgStudyIdInfo': {'id': 'REC16-051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'unilateral', 'interventionNames': ['Other: Activa Bioactive']}, {'type': 'EXPERIMENTAL', 'label': 'bilateral', 'interventionNames': ['Other: Activa Bioactive']}], 'interventions': [{'name': 'Activa Bioactive', 'type': 'OTHER', 'description': 'Before cavity preparation and restoration, masticatory muscles activity will be evaluated by using electromyography. An electromyography detects the electrical potential generated by muscle cells. A total of 40 posterior teeth will be selected for this study and grouped into 2 main groups (20 for each group)) according to presence of caries in one or both side in patient (unilateral or bilateral). Split mouth technique will be used. The affected teeth will be treated by removing the caries and restored tooth with bulk fill composite material, after restoring the affected teeth. Masticatory muscles activity will be evaluated by using electromyography to detect any changes in masticatory muscles activity before and after restoration.', 'armGroupLabels': ['bilateral', 'unilateral']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'AlAzhar University, Faculty of Dentistry', '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': 'Ahmed Ibrahim Ahmed', 'investigatorAffiliation': 'Al-Azhar University'}}}}