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

NCT07126366 | Not Yet Recruiting DMC

• 1 other identifier: 14422023489475
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

White Spot Lesion of Tooth

Keywords

S-PRG; White spot lesion

Outcome Measures

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)

  at baseline, 3 months, 6 months and 12 months

Secondary Outcomes (2)

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

  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)

  at baseline, 3 months,6 months and 12 months

Study Arms (2)

S-PRG-Barrier coat ,Shofu Inc. Kyoto, Japan

ACTIVE COMPARATOR

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.

Other: S-PRG Barrier coat

S-PRG PROPHYLAXIS PASTE

EXPERIMENTAL

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.

Other: S-PRG Prophylaxis paste

Interventions

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-Barrier coat ,Shofu Inc. Kyoto, Japan

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.

S-PRG PROPHYLAXIS PASTE

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

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

CONTACT

01126538662; engy.aref@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Engy Hassan Aref

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: August 17, 2025
• Study Start: September 21, 2025
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): October 21, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-07