Color Stability of S-PRG Resin-Based Light-Cure Varnish and Prophylaxis Paste on White Spot Lesions

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-35
SponsorCairo University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • S-PRG Barrier coat

    Other intervention

    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.

  • S-PRG Prophylaxis paste

    Other intervention

    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.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: S-PRG-Barrier coat ,Shofu Inc. Kyoto, JapanActive comparator 1 intervention
Group B: S-PRG PROPHYLAXIS PASTEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
at baseline, 3 months, 6 months and 12 months

Secondary outcomes

1

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)

Time frame
at baseline, 3 months,6 months and 12 months
2

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) -

Time frame
at baseline, 3 months,6 months and 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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