Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 4:02 PM
Study NCT ID:
NCT05562856
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2022-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of White Spot Lesions Treated by S-PRG Material and Composite Sealants in Comparison With ICON
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', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2022-09-16', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessments of caries lesion state of WSLs:', 'timeFrame': '1 year', 'description': 'Assessing of carious lesions state of WSLs, was performed by using Diagnodent pen to record the progression or regression of caries by time. The assessment of the WSLs demineralization condition took place before intervention (baseline) \\[T0\\], immediately after intervention \\[T1\\], 3 months later \\[T2\\] ,6 months later \\[T3\\] and 1 year later \\[T4\\].'}], 'secondaryOutcomes': [{'measure': 'Assessment of color change of WSLs:', 'timeFrame': '1 year', 'description': 'The difference in color of the WSLs were performed by Vita Easyshade V at the five distinct times: before intervention (baseline) \\[T0\\], immediately after intervention \\[T1\\], 3 months later \\[T2\\] ,6 months later \\[T3\\] and 1 year later \\[T4\\].'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['White Spot Lesions']}, 'descriptionModule': {'briefSummary': 'Dental caries is the primary cause of tooth loss and oral diseases. Dental decay is a continuous pathological process with loss of tooth minerals, demineralization, which involves the destruction of tooth structure from acids. The first sign of early active demineralization is white spot lesions (WSLs) on the tooth surface, meanwhile, subsurface active mineral decomposition.', 'detailedDescription': 'Deposition of minerals depends on the equilibrium between demineralization and remineralization which may happen as a natural repair mechanism. The aim of this trial is to comparatively evaluate the efficacy of surface pre-reacted glass filler (S-PRG) Barrier Coat coating material against the Icon resin infiltration in the ability to improve the caries lesion state of the WSLs along 1 year. Laser fluorescence was used to compare the two materials to evaluate the caries progression. PRG Barrier Coat group showed immediate significant improvement in LF scores in demineralization progress and inhibition of caries progression with a significant improved effect. S-PRG Barrier Coat was clinically successful strategy in inhibition of caries and improve remineralization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients within 20-40 years of age.\n* Each patient has 4 or more WSLs.\n* Mild and moderate WSLs according to Gorelick's scale.\n* Good oral hygiene and willing patients who can attend the study visits.\n* a Symmetrical number of permanent teeth in each arch (mesial to second molars).\n\nExclusion Criteria:\n\n* Active carious lesions.\n* Facial surface restorations.\n* Intrinsic and extrinsic stains.\n* Patients who have a significant medical history or if they smoke.\n* Criteria for discontinuation; Mortality and acquiring severe debilitating disease"}, 'identificationModule': {'nctId': 'NCT05562856', 'briefTitle': 'Clinical Evaluation of White Spot Lesions Treated by S-PRG Material and Composite Sealants in Comparison With ICON', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Clinical Evaluation of White Spot Lesions Treated by Surface Pre-reacted Glass Filler Coating Material and Composite Sealants in Comparison With Icon Resin Infiltration by Using Laser Fluorescence and Spectrophotometer', 'orgStudyIdInfo': {'id': '350/466/08/10/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'surface pre-reacted glass filler coating material', 'description': 'surface pre-reacted glass filler coating material used to remineralize WSLs', 'interventionNames': ['Combination Product: surface pre-reacted glass filler coating material']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'micro-invasive resin infiltration technique (Icon)', 'description': 'micro-invasive resin infiltration technique (Icon) in the ability to improve caries lesion state (LF scores) and making the WSLs', 'interventionNames': ['Combination Product: surface pre-reacted glass filler coating material']}, {'type': 'EXPERIMENTAL', 'label': 'Permaseal resin', 'description': 'Permaseal composite resin sealant as micro-invasive resin infiltration technique in the ability to improve caries lesion state (LF scores) and making the WSLs', 'interventionNames': ['Combination Product: surface pre-reacted glass filler coating material']}, {'type': 'EXPERIMENTAL', 'label': 'Optiguard resin', 'description': 'Optiguardcomposite resin sealant as micro-invasive resin infiltration technique in the ability to improve caries lesion state (LF scores) and making the WSLs', 'interventionNames': ['Combination Product: surface pre-reacted glass filler coating material']}], 'interventions': [{'name': 'surface pre-reacted glass filler coating material', 'type': 'COMBINATION_PRODUCT', 'description': 'the ability to improve the aesthetic appearance (masking) and caries lesion state of the WSLs', 'armGroupLabels': ['Optiguard resin', 'Permaseal resin', 'micro-invasive resin infiltration technique (Icon)', 'surface pre-reacted glass filler coating material']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11768', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Mohamed Wakwak', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Khalid Noman, PROF', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alazhar Univerisity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Eslam Gabr', 'investigatorAffiliation': 'Al-Azhar University'}}}}