Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT06566833
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2024-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Different Remineralizing Strategies on the Management of Early Carious Lesions in Primary Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'C447032', 'term': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}], '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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the remineralization of early carious lesions in primary teeth', 'timeFrame': '3,6,9 and12 months', 'description': 'comparing the remineralization effect of different remineralizing agents both qualitatively by comparing the change in ICDAS -11 criteria and quantitatively by using laser fluorescence scores using kavo DIAGNOdent classic after intensive mode of application of the different remineralizing agents'}], 'secondaryOutcomes': [{'measure': 'comparing the change in esthetic appearance of early carious lesion before and after treatment', 'timeFrame': '12 months', 'description': 'comparing the change in lesion size using standardized photographs quantitatively by calculating pixel size of the lesion before treatment and after 6 and 12 months of intensive mode of application of the different remineralizing agents using ImageJ software program for image analysis. Assessing the esthetic appearance of the lesions will be done subjectively by using a visual analogue scale score from 1 to 7'}, {'measure': 'comparing the antibacterial effect of different remineralizing agents against streptococcus mutans', 'timeFrame': '3 months', 'description': 'Supragingival plaque samples will be collected at baseline then after 48 hours, 1 months and 3 months of application of the materials in an intensive mode. log count of streptococcus mutans is determined using disk diffusion method using mitis salivaris agar plates'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['curodont repair fluoride plus', 'CPP-ACPF', 'sodium fluoride varnish', 'guided enamel regeneration'], 'conditions': ['White Spot Lesion']}, 'referencesModule': {'references': [{'pmid': '33662244', 'type': 'BACKGROUND', 'citation': 'Mekky AI, Dowidar KML, Talaat DM. Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish in Remineralization of Early Carious Lesions in Primary Dentition: Randomized Clinical Trial. Pediatr Dent. 2021 Jan 15;43(1):17-23.'}]}, 'descriptionModule': {'briefSummary': 'the primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode. The secondary aim of the study is to compare their antibacterial effect against streptococcus mutans and their effect on reducing the size of the lesions.', 'detailedDescription': 'The primary aim of the study is to compare the effect of curodont repair fluoride plus (self-assembling peptide p11-4 with 0.5% sodium fluoride) with MI varnish (casein phosphopeptide amorphous calcium phosphate fluoride) and Colgate fluoride varnish (5% sodium fluoride) in remineralization of early carious lesions in primary anterior teeth. The study sample is consisted of 66 patients aged 3-6 years old with at least 2 white spot lesions in their primary anterior teeth who are assigned into control group (n=22): colgate fluoride varnish, test group 1(n=22): MI varnish and test group 2 (n=22) :curodont repair fluoride plus. Each material is applied once every 2 weeks for 3 times (intensive mode of application). The secondary aim of the study is to determine the antibacterial effect of each material against streptococcus mutans is compared by obtaining a plaque sample at baseline then after application by 48 hours, 1 months and 3 months and culturing using disk diffusion method for determining the log count of streptococcus mutans at each time point. Another secondary aim is to determine the change in lesion size at baseline and after 6 months and 12 months using standardized photographs with a digital camera.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. healthy children\n2. age range 3-6\n3. at least 2 early carious lesions\n\nExclusion Criteria:\n\n1. Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases.\n2. Application of fluoride varnish less than 3 months prior to study treatment.\n3. Any metabolic disorders affecting bone turnover.\n4. Concurrent participation in another clinical trial.\n5. Patients receiving any antibiotic within 1 month prior to plaque sample collection'}, 'identificationModule': {'nctId': 'NCT06566833', 'briefTitle': 'Effectiveness of Different Remineralizing Strategies on the Management of Early Carious Lesions in Primary Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effectiveness of Different Remineralizing Strategies on the Management of Early Carious Lesions in Primary Teeth (Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '00010556 - IORG 0008839'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'curodont repair fluoride plus', 'description': 'self-assembling peptide (p11-4) with 0.05% sodium fluoride', 'interventionNames': ['Drug: self assmbling peptide p11-4 combined with 0.05% fluoride']}, {'type': 'EXPERIMENTAL', 'label': 'CPP-ACPF varnish', 'description': 'casein phoshphopeptide amorphous calcium phosphate fluoride (CPP-ACPF )', 'interventionNames': ['Drug: Casein phosphopeptide amorphous calcium phosphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5 % sodium fluoride varnish', 'description': '5% sodium fluoride varnish', 'interventionNames': ['Drug: 5% sodium fluoride varnish']}], 'interventions': [{'name': 'self assmbling peptide p11-4 combined with 0.05% fluoride', 'type': 'DRUG', 'otherNames': ['SAP P11-4'], 'description': 'biomimetic remineralizing agent', 'armGroupLabels': ['curodont repair fluoride plus']}, {'name': 'Casein phosphopeptide amorphous calcium phosphate', 'type': 'DRUG', 'otherNames': ['CPP-ACPF'], 'description': 'remineralizing agents that acts as a fluoride booster', 'armGroupLabels': ['CPP-ACPF varnish']}, {'name': '5% sodium fluoride varnish', 'type': 'DRUG', 'otherNames': ['5% NaF'], 'description': 'remineralizing agent that is used as a gold standard for remineralization', 'armGroupLabels': ['5 % sodium fluoride varnish']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'state': 'Professor', 'country': 'Egypt', 'facility': 'Karin Dowidar', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'karin dowidar, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of Dentistry, Alexandria university, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'only the results of the primary and secondary outcomes of the study will be published after study completion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Sarah Khairy', 'investigatorAffiliation': 'Alexandria University'}}}}