Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-29 @ 12:23 AM
Study NCT ID:
NCT07126366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Color Stability of S-PRG Resin-Based Light-Cure Varnish and Prophylaxis Paste on White Spot Lesions
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-10-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-08-10', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual assessment using ICDAS criteria at baseline, 3, 6, and 12 months', 'timeFrame': 'at baseline, 3 months, 6 months and 12 months', 'description': 'Primary Outcome Measure 1:\n\nTitle: Visual Caries Assessment Using ICDAS Criteria Description: Visual/tactile examination of white spot lesions according to the International Caries Detection and Assessment System (ICDAS).\n\nScore 0: No visible caries (sound tooth)\n\nScore 1: First visual change in enamel (white or brown opacity, visible only when dry)\n\nScore 2: Distinct visual change in enamel (opacity visible wet and dry)\n\nScore 3: Localized enamel breakdown (no visible dentin)\n\nScore 4: Underlying dark shadow from dentin (no cavitation)\n\nScore 5: Distinct cavity with visible dentin\n\nScore 6: Extensive cavity with visible dentin Time Frame: Baseline, 3 months, 6 months, 12 months Unit of Measure: ICDAS score (ordinal scale: 0-6)'}], 'secondaryOutcomes': [{'measure': 'Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months.', 'timeFrame': 'at baseline, 3 months,6 months and 12 months', 'description': 'Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months.\n\nClinical success rate (ΔE ≤ 3.7)'}, {'measure': 'Patient satisfaction scores (VAS 0-10) Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months Clinical success rate (ΔE ≤ 3.7)', 'timeFrame': 'at baseline, 3 months,6 months and 12 months', 'description': 'Patient satisfaction scores (VAS 0-10) Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months Clinical success rate (ΔE ≤ 3.7) -'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['S-PRG', 'White spot lesion'], 'conditions': ['White Spot Lesion of Tooth']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate and compare the long-term color stability of two bioactive materials used in the management of white spot lesions: Surface Pre-Reacted Glass (S-PRG) containing resin-based light-cured varnish and S-PRG containing prophylaxis paste. The study will assess color changes over a 12-month period to determine which material better maintains aesthetic integrity while providing therapeutic benefits for demineralized enamel surfaces.', 'detailedDescription': 'White spot lesions (WSLs), particularly prevalent in post-orthodontic patients (up to 96%), pose both aesthetic and pathological challenges due to subsurface enamel demineralization that alters optical properties. Although fluoride-based remineralization therapies can arrest lesion progression, they often fail to restore the natural appearance of enamel, leaving residual opacity.\n\nSurface Pre-Reacted Glass (S-PRG) technology offers a bioactive alternative, releasing multiple therapeutic ions (e.g., fluoride, strontium, silicate) to enhance remineralization, neutralize acids, and exhibit antibacterial effects. S-PRG materials are available in resin-based varnishes and prophylaxis pastes; however, their long-term color stability remains underexplored.\n\nGiven that aesthetic outcomes significantly impact patient satisfaction, this study aims to compare the 12-month color stability of S-PRG resin-based varnish versus S-PRG prophylaxis paste. Color changes may result from water sorption, dietary staining, polymer degradation, and ion interaction with oral fluids. The comparison is clinically relevant as both materials utilize the same bioactive core but differ in formulation and application methods.\n\nA 12-month observation period allows assessment under real oral conditions, including pH fluctuations and staining challenges. Objective color evaluation using CIE Lab\\* values and spectrophotometry ensures standardized, clinically relevant data. The study targets anterior teeth due to their aesthetic significance and addresses a critical gap in the literature, supporting evidence-based selection of materials that balance therapeutic efficacy with long-term aesthetic outcomes in WSL management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient consulting in the outpatient clinic.\n* Enamel caries in anterior permanent teeth according to ICDAS-1 and ICDAS-2.\n* Good oral hygiene.\n* Provide informed consent.\n* Cooperative and willing to participate in the trial.\n* Male or female.\n* Adult patients aged 16 to 35 years.\n\nExclusion Criteria:\n\n* Spontaneous or elicited pain from caries.\n* Tooth mobility.\n* Signs of pulpal infection.\n* Severe medical conditions that would not allow management in the clinic.\n* Hereditary developmental defects such as amelogenesis imperfecta or dentinogenesis imperfecta.\n* Known allergies or sensitivities to dental materials, including fluoride\n* Inability to return for recall visits.\n* Poor oral hygiene.\n* Refusal to participate in the study.'}, 'identificationModule': {'nctId': 'NCT07126366', 'briefTitle': 'Color Stability of S-PRG Resin-Based Light-Cure Varnish and Prophylaxis Paste on White Spot Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'COLOR STABILITY OF S-PRG RESIN-BASED LIGHT CURE VARNISH AND PROPHYLAXIS PASTE ON WHITE SPOT LESIONS: A 12-MONTH RANDOMIZED CLINICAL TRIAL', 'orgStudyIdInfo': {'id': '14422023489475'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'S-PRG-Barrier coat ,Shofu Inc. Kyoto, Japan', 'description': 'A light-cured Giomer varnish for prolonged hypersensitivity relief. Seals and protects exposed dentinal tubules to prevent pain. Ideal for patients experiencing loss of enamel, gingival recession or temporary sensitivity due to whitening.', 'interventionNames': ['Other: S-PRG Barrier coat']}, {'type': 'EXPERIMENTAL', 'label': 'S-PRG PROPHYLAXIS PASTE', 'description': 'S-PRG PROPHYLAXIS PASTE is a bioactive Giomer-based paste containing S-PRG particles that release six therapeutic ions-fluoride, strontium, borate, aluminum, sodium, and silicate each contributing to remineralization, antibacterial effects, and dentin sensitivity reduction.', 'interventionNames': ['Other: S-PRG Prophylaxis paste']}], 'interventions': [{'name': 'S-PRG Barrier coat', 'type': 'OTHER', 'description': 'A light-cured Giomer varnish for prolonged hypersensitivity relief. Seals and protects exposed dentinal tubules to prevent pain. Ideal for patients experiencing loss of enamel, gingival recession or temporary sensitivity due to whitening.', 'armGroupLabels': ['S-PRG-Barrier coat ,Shofu Inc. Kyoto, Japan']}, {'name': 'S-PRG Prophylaxis paste', 'type': 'OTHER', 'description': 'S-PRG Prophylaxis paste is a bioactive Giomer-based paste containing S-PRG particles that release six therapeutic ions-fluoride, strontium, borate, aluminum, sodium, and silicate each contributing to remineralization, antibacterial effects, and dentin sensitivity reduction.', 'armGroupLabels': ['S-PRG PROPHYLAXIS PASTE']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'engy hassan aref abdelaziz engy aref, bachelor degree (BDS)', 'role': 'CONTACT', 'email': 'engy.aref@dentistry.cu.edu.eg', 'phone': '01126538662'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Engy Hassan Aref', 'investigatorFullName': 'Engy hassan aref abdelaziz', 'investigatorAffiliation': 'Cairo University'}}}}