Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-01-16 @ 1:10 AM
Study NCT ID:
NCT03731403
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2018-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remineralization Potential of MI Varnish Versus Fluoride Varnish on White Spot Lesions in Maxillary Primary Incisors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C447032', 'term': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'id': 'D005459', 'term': 'Fluorides'}], 'ancestors': [{'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-17', 'studyFirstSubmitDate': '2018-11-03', 'studyFirstSubmitQcDate': '2018-11-03', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caries activity', 'timeFrame': 'Change from base line, after application at 3, 6, 9 last follow up 12 months', 'description': 'Measured by ICDAS II'}], 'secondaryOutcomes': [{'measure': 'Remineralization', 'timeFrame': 'Change from base line, after application at 3, 6, 9 last follow up 12 months', 'description': 'Measured by EDI'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early childhood caries', 'Casein phosphopeptides-amorphous calcium phosphate', 'fluoride', 'remineralization potential', 'varnish'], 'conditions': ['Remineralization Effect of the Varnish on White Spot Lesions']}, 'descriptionModule': {'briefSummary': 'Remineralization effect of CPP-ACP and Fluoride (MI varnish) versus Fluoride varnish on white spot lesions in maxillary primary incisors', 'detailedDescription': 'Early childhood caries (ECC) is a very common and consequential chronic disease affecting young children ( Çolak et al., 2013). The prevalence of ECC in Egypt is high, it is about (78%) according to the last Egyptian Report, 2014.\n\nECC begins with white-spot lesions, and caries can progress continuously, leading to complete destruction of the crown. Calcium and phosphate ions are more readily lost for children because lower mineralization of deciduous enamel. The disease usually develops very quickly and causes many childhood health problems, such as caries-related toothache and infection.\n\nDemineralization and remineralization are dynamic processes in caries initiation, progression, and reversal. Therefore, regulation of the demineralization- remineralization balance is a key to caries prevention and treatment. The ideal method of increasing remineralization is reconstructing the depleted tissues with hydroxyapatite, which is the same inorganic component as the enamel.\n\nFluoride varnishes have been the standard practice for the professional application of fluoride.\n\nCasien PhosphoPeptide (CPP) is a sticky protein that binds and stabilizes calcium and phosphate ions in an amorphous state. CPP-ACP has been shown to adhere to teeth surfaces.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children with white spot lesions on their incisors.\n2. Age ranging 3-5 years.\n3. Good general health.\n\nExclusion Criteria:\n\n1\\. Chronic use of medications or antibiotics 2. lack of cooperation in the oral examination 3. Allergies to milk protein or benzoate preservatives 4. Presence of oral soft-tissue lesions or enamel hypoplasia at baseline examination, 5. Children who have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03731403', 'briefTitle': 'Remineralization Potential of MI Varnish Versus Fluoride Varnish on White Spot Lesions in Maxillary Primary Incisors', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Remineralization Potential of MI Varnish(CPP-ACP and Fluoride) Versus Fluoride Varnish in Controlling White Spot Lesions in Maxillary Primary Incisors: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CEBD-CU-28-10-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MI Varnish', 'interventionNames': ['Other: MI varnish']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Profluorid Varnish', 'interventionNames': ['Other: MI varnish']}], 'interventions': [{'name': 'MI varnish', 'type': 'OTHER', 'otherNames': ['CPP- ACP with fluoride'], 'description': 'CPP- ACP with 5 % sodium fluoride GC', 'armGroupLabels': ['MI Varnish', 'Profluorid Varnish']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry- Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Samaa Sayed', 'investigatorAffiliation': 'Cairo University'}}}}