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NCT Number: NCT07126366

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

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.

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Key information

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Surface 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.

Given 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.

A 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Cooperative and willing to participate in the trial.
  • Male or female.
  • Adult patients aged 16 to 35 years.

Exclusion criteria

  • Spontaneous or elicited pain from caries.
  • Tooth mobility.
  • Signs of pulpal infection.
  • Severe medical conditions that would not allow management in the clinic.
  • Hereditary developmental defects such as amelogenesis imperfecta or dentinogenesis imperfecta.
  • Known allergies or sensitivities to dental materials, including fluoride
  • Inability to return for recall visits.
  • Poor oral hygiene.
  • Refusal to participate in the study.

Treatment and study plan

S-PRG Barrier coat

Other

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

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.

Primary outcomes

  1. Visual assessment using ICDAS criteria at baseline, 3, 6, and 12 months

    Time frame: at baseline, 3 months, 6 months 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

  1. Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months.

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

    Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months.

    Clinical success rate (ΔE ≤ 3.7)

  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)

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

    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) -

Study contacts

Contact information is provided by the study sponsor or research team.

engy hassan aref abdelaziz engy aref, bachelor degree (BDS)

CONTACT

[email protected]

01126538662

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

COLOR STABILITY OF S-PRG RESIN-BASED LIGHT CURE VARNISH AND PROPHYLAXIS PASTE ON WHITE SPOT LESIONS: A 12-MONTH RANDOMIZED CLINICAL TRIAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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