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

NCT ID: NCT07126366

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-21
• Study Completion Date: 2026-10-21

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.

Detailed Description

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.

Conditions

White Spot Lesion of Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

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.

Group Type: ACTIVE_COMPARATOR

S-PRG Barrier coat

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

S-PRG Prophylaxis paste

Intervention Type: 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.

Interventions

S-PRG Barrier coat

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.

Intervention Type: OTHER

S-PRG Prophylaxis paste

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Engy hassan aref abdelaziz

Dr. Engy Hassan Aref

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

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

Role: CONTACT

engy.aref@dentistry.cu.edu.eg

01126538662

Other Identifiers

14422023489475

Identifier Type: -

Identifier Source: org_study_id