Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-30 @ 5:14 AM
Study NCT ID:
NCT05775250
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2023-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Two Varnishes on the Improvement of White Spot Lesions in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2023-03-07', 'studyFirstSubmitQcDate': '2023-03-07', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'white spot lesion color change', 'timeFrame': '6 months', 'description': 'assessment of white spot lesion color by using spectrophotometer'}], 'secondaryOutcomes': [{'measure': 'Patient response to the treatment', 'timeFrame': '6 months', 'description': 'Patient response to the treatment using facial image scale, scores from 1 to 5'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['white spot lesion', 'fluoride varnish', 'Giomer Varnish'], 'conditions': ['White Spot Lesion']}, 'descriptionModule': {'briefSummary': 'A randomized control trial evaluating the effect of the Giomer varnish versus fluoride varnish on the color improvement of the white spot lesion in permanent anterior teeth of children aged between 8-14 years by using a spectrophotometer at baseline, after 1 month, 3 months and 6 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Patients with good general health.\n\n * Adequate oral hygiene,\n * Patients who didn't receive remineralizing agents during the last 3 months other than regular toothpaste.\n\nExclusion Criteria:\n\n* Uncooperative child.\n* Active carious lesion.\n* Labial surface restoration."}, 'identificationModule': {'nctId': 'NCT05775250', 'briefTitle': 'Evaluation of Two Varnishes on the Improvement of White Spot Lesions in Children', 'organization': {'class': 'OTHER', 'fullName': 'October University for Modern Sciences and Arts'}, 'officialTitle': 'Evaluation of Giomer Varnish Versus Fluoride Varnish on The Color Improvement of White Spot Lesions in Permanent Teeth of Children: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'REC-D 262-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'giomer varnish', 'description': 'Giomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once.', 'interventionNames': ['Drug: giomer varnish']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fluoride varnish', 'description': '5% NaF fluoride varnish, it will be administrated once.', 'interventionNames': ['Drug: giomer varnish']}], 'interventions': [{'name': 'giomer varnish', 'type': 'DRUG', 'description': 'Giomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once.', 'armGroupLabels': ['fluoride varnish', 'giomer varnish']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3210001', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'October University of Modern Sciences and Arts', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Naglaa I Ezzeldin, Ass. Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'October University for Modern Sciences and arts, Cairo, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October University for Modern Sciences and Arts', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Naglaa Ibrahim Ezz', 'investigatorAffiliation': 'October University for Modern Sciences and Arts'}}}}