About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient consulting in the outpatient clinic.
Enamel caries in anterior permanent teeth according to ICDAS-1 and ICDAS-2.
Good oral hygiene.
Provide informed consent.
Disqualifiers
Spontaneous or elicited pain from caries.
Tooth mobility.
Signs of pulpal infection.
Severe medical conditions that would not allow management in the clinic.
Trial design
Parallel
Treatments tested in this trial
S-PRG Barrier coat
Other interventionA 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.
S-PRG Prophylaxis paste
Other interventionS-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.
Treatment groups
Trial outcomes
Primary outcomes
Visual assessment using ICDAS criteria at baseline, 3, 6, and 12 months
Primary Outcome Measure 1: Title: Visual Caries Assessment Using ICDAS Criteria Description: Visual/tactile examination of white spot lesions according to the International Caries Detection and Assessment System (ICDAS). Score 0: No visible caries (sound tooth) Score 1: First visual change in enamel (white or brown opacity, visible only when dry) Score 2: Distinct visual change in enamel (opacity visible wet and dry) Score 3: Localized enamel breakdown (no visible dentin) Score 4: Underlying dark shadow from dentin (no cavitation) Score 5: Distinct cavity with visible dentin Score 6: Extensive cavity with visible dentin Time Frame: Baseline, 3 months, 6 months, 12 months Unit of Measure: ICDAS score (ordinal scale: 0-6)
Secondary outcomes
Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months.
Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months. Clinical success rate (ΔE ≤ 3.7)
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)
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) -
Locations
Sponsors and contacts
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