Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-06 @ 7:42 PM
Study NCT ID:
NCT06576960
Status:
COMPLETED
Last Update Posted:
2024-08-29
First Post:
2024-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caries Inhibitory Effect of Nano Silver and Tri Calcium Phosphate Varnishes Among Visually Impaired Children
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-08-28', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary PH', 'timeFrame': '6 months', 'description': 'Salivary power of hydrogen at baseline, one month, 3months and six months after intervention'}, {'measure': 'Salivary streptococcus mutants count', 'timeFrame': '6months', 'description': 'Count of bacteria at baseline, one day, 3months and six months after intervention'}, {'measure': 'Lactobacillus count', 'timeFrame': '6 months', 'description': 'Count of bacteria at baseline, one day, 3months and six months after intervention'}, {'measure': 'Immunoglobulin A', 'timeFrame': '6months', 'description': 'Level of immunoglobulin A at saliva at baseline, one day, 3months and 6 months after intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'Assessment of pH,streptococcus mutants count, lactobacillus count and immunoglobulin A among visually impaired children after nano silver varnish application it tri calcium phosphate phosphate varnish application', 'detailedDescription': 'Sixty children will be randomly divided into three equal treatment groups, composed of 20 children each, according to the type of material used as follows:\n\n* Group I: children will receive oral health education and nano silver fluoride varnish.\n* Group II: children will receive oral health education and tri calcium phosphate varnish.\n* Group III: children will receive oral health education\n\nfor all children ,Assessment of pH, streptococcus mutants count, lactobacillus count and immunoglobulin A will be assessed at baseline, one day , 3 months and 6 months after application'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nVisually impaired children\n\nExclusion Criteria:\n\n* uncooperative children or children not willing to participate in the study.\n* Children with systemic diseases\n* Children with bronchial asthma.\n* Children who were on antibiotic or medications that might affect oral flora or salivary flow taken within the previous 3 months\n* History of fluoride treatment in the past 3-4 weeks.'}, 'identificationModule': {'nctId': 'NCT06576960', 'acronym': 'Prevention', 'briefTitle': 'Caries Inhibitory Effect of Nano Silver and Tri Calcium Phosphate Varnishes Among Visually Impaired Children', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Caries Inhibitory Effect of Nano Silver Varnish Versus Tri Calcium Phosphate Varnish Among Children With Visual Impairment', 'orgStudyIdInfo': {'id': 'OH12-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nano silver varnish', 'description': 'new fluoride varnish', 'interventionNames': ['Drug: Nano silver fluoride varnish and tri calcium phosphate varnish']}, {'type': 'EXPERIMENTAL', 'label': 'tri calcium phosphate varnish', 'description': 'fluoride varnish contain calcium phosphate', 'interventionNames': ['Drug: Nano silver fluoride varnish and tri calcium phosphate varnish']}, {'type': 'NO_INTERVENTION', 'label': 'health education'}], 'interventions': [{'name': 'Nano silver fluoride varnish and tri calcium phosphate varnish', 'type': 'DRUG', 'otherNames': ['health education'], 'description': 'Fluoride varnishes', 'armGroupLabels': ['nano silver varnish', 'tri calcium phosphate varnish']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'Tanta City', 'country': 'Egypt', 'facility': 'Faculty of dentistry', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Hatem Amin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of dentistry . Tanta university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadeer Mohammed Abd El wahab', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'El Mahalla Elkobra', 'investigatorFullName': 'Hadeer Mohammed Abd El wahab', 'investigatorAffiliation': 'Tanta University'}}}}