Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT03779893
Status:
UNKNOWN
Last Update Posted:
2019-01-15
First Post:
2018-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-12', 'studyFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention of sealant', 'timeFrame': 'one year', 'description': 'rate of sealant loss'}], 'secondaryOutcomes': [{'measure': 'Caries incidence', 'timeFrame': 'one year', 'description': 'rate of caries initiation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caries, Dental']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the performance; in terms of retention and caries inhibition; of the newly introduced bioactive resin based pits and fissure sealant versus conventional resin based pits and fissure sealant in caries susceptible fissures in posterior molars in patients at risk of caries. Evaluation will be done by visual tactile examination \\& VistaCAM.', 'detailedDescription': "In the investigator's study the comparator material will be BioCoat® by Premier® ; new bioactive resin pits and fissures sealant featuring SmartCap™ Technology. SmartCap™ Technology utilizes patented semi-permeable resin microcapsules. In BioCoat, the rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, which diffuse in and out of the sealant. Greater fluoride uptake in the presence of calcium and phosphate ions is assumed.\n\nWith limited evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it was found beneficial to evaluate the newly introduced material using a randomized controlled trial to test the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as conventional resin based pits and fissure sealant in susceptible fissures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria of participants:\n\n* Patients with bilateral caries susceptible fissures in molars showing no signs of caries.\n* 19 - 40 years.\n* Males or Females.\n* Co-operative patients approving to participate in the trial.\n\nExclusion criteria of participants:\n\n* Patients younger than 19 years old or older than 40 years old.\n* Pregnancy.\n* Disabilities.\n* Systemic disease or severe medical complications.\n* Allergic history concerning methacrylate.\n* Rampant caries.\n* Heavy smoking.\n* Xerostomia.\n* Lack of compliance.\n* Evidence of severe bruxism, clenching, or tempromandibular joint disorders.'}, 'identificationModule': {'nctId': 'NCT03779893', 'briefTitle': 'Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Evaluation of Bioactive Resin Based Pits & Fissures Sealants Versus Conventional Resin Based Pits & Fissures Sealants in Caries Susceptible Fissures in Permanent Molars: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '14011989'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional group', 'description': 'Conventional resin based Pits \\& fissures sealant 3M™ Clinpro™ Sealant is administrated', 'interventionNames': ['Combination Product: 3M™ Clinpro™ Sealant.']}, {'type': 'EXPERIMENTAL', 'label': 'bioactive group', 'description': 'Bioactive Pits \\& fissures sealant BioCoat® by Premier®.', 'interventionNames': ['Combination Product: BioCoat® by Premier®.']}], 'interventions': [{'name': 'BioCoat® by Premier®.', 'type': 'COMBINATION_PRODUCT', 'description': 'Bioactive pits and fissure sealant', 'armGroupLabels': ['bioactive group']}, {'name': '3M™ Clinpro™ Sealant.', 'type': 'COMBINATION_PRODUCT', 'description': 'conventional pits and fissure sealant', 'armGroupLabels': ['conventional group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Alaa Fathi Abdelsalam', 'investigatorAffiliation': 'Cairo University'}}}}