Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT04793256
Status:
UNKNOWN
Last Update Posted:
2021-03-11
First Post:
2021-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant (Part 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No one is blinded ( unfortunately) as fissure sealant will be obvious'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be randomized, allocation-blinded, two-arm, parallel-group trial.\n\nThe participants will be randomized on a 1: 1 allocation ratio to receive one of the following interventions:\n\n* Resin-based fissure sealant FS.\n* Fluoride varnish FV'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 91}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2021-03-09', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time of application (continuous outcome, (minutes) will be measured with stopwatch.', 'timeFrame': 'Through application of interventions in treatment visit( baseline)', 'description': 'Time of application (continuous outcome, (minutes) will be measured with stopwatch.'}, {'measure': 'acceptability will be measured by questionnaire', 'timeFrame': 'through study completion, an average of one year', 'description': 'I will ask the parent and child if this trial is acceptable or not'}, {'measure': 'adverse effect will be measured by questionnaire', 'timeFrame': 'through study completion, an average of one year', 'description': 'Questionnaire for the parent (allergy, diarrhea or vomiting )'}], 'primaryOutcomes': [{'measure': 'Clinical-effectiveness (will be measured with DFS', 'timeFrame': 'Through study completion, an average of one year', 'description': 'Clinical-effectiveness (will be measured by DFS) Clinical effectiveness (continuous outcome will be measured with DFS D Decayed in permanent molar Filling in permanent molar S Surface'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness (will be measured with Incremental cost effective ratio ICER', 'timeFrame': 'through study completion, an average of one year', 'description': 'Cost-effectiveness (will be measured with Cost-effectiveness will be calculated based on the following measures:- Economic measures (continuous outcome, (money) will be measured with Calculate The total cost of each of FV and FS in every visit) . Clinical effectiveness (continuous outcome will be measured with DFS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cost Effectiveness']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is determine the cost-effectiveness, clinical- effectiveness, acceptability and adverse effect of resin sealants versus the fluoride varnish for the prevention of dental caries on newly erupted permanent molars.', 'detailedDescription': 'A Cochrane systematic reviews found low quality evidence supporting Current practice guidelines that recommend the use of Resin based fissure sealant over Fluoride varnish in prevent dental caries. However, they did not address the cost-effectiveness, A more recent systematic review and meta-analysis concluded that no statistical significance difference between Resin based fissure sealant and Fluoride varnish with a high-quality evidence in prevent dental caries.\n\nThis trial will measure cost effectiveness and clinical effectiveness for resin fissure sealant and fluoride varnish.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Healthy children with no physical or mental disorders. Children with newly fully erupted permanent molars (PMs).\n\nExclusion Criteria:\n\n* Teeth will be excluded from the study if they had any of the following:\n\n * Dental caries in dentine\n * History of pain or swelling. Parents refused their children participate in the trial'}, 'identificationModule': {'nctId': 'NCT04793256', 'briefTitle': 'Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant (Part 2)', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children: A Randomized Clinical Trial(Part 2).', 'orgStudyIdInfo': {'id': '115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride). Group (1)', 'interventionNames': ['Device: Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride).']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'comparator', 'description': 'Resin based fissure sealant (3M Clinpro Sealant, light cure, low viscosity, fluoride release).group (2)', 'interventionNames': ['Device: Resin based fissure sealant (3M Clinpro Sealant)']}], 'interventions': [{'name': 'Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride).', 'type': 'DEVICE', 'otherNames': ['5% sodium fluoride varnish 3M'], 'description': '5% sodium fluoride Varnish is a fluoride varnish which is applied to tooth surfaces', 'armGroupLabels': ['intervention']}, {'name': 'Resin based fissure sealant (3M Clinpro Sealant)', 'type': 'DEVICE', 'otherNames': ['Resin based fissure sealant 3M'], 'description': 'teeth will be isolated with cotton rolls and saliva ejector than etching for pits and fissure sealant', 'armGroupLabels': ['comparator']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'samah Ahmed, B.sc', 'role': 'CONTACT', 'email': 'samah.ahmed@dentistry.cu.edu.eg', 'phone': '00201112000386'}, {'name': 'Passant Nagi, phd', 'role': 'CONTACT', 'email': 'passant.Nagi@dentistry.cu.edu.eg', 'phone': '0201280557107'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Samah AbdelHafez Ahmed', 'investigatorAffiliation': 'Cairo University'}}}}