Remineralization Potential of PRG Barrier Coat Versus Fluoride Varnish in White Spot Lesions in Permanent Anterior Teeth of Children

Not Applicable

Not yet recruiting

• Conditions: White Spot Lesion of Tooth; Demineralization

• Registration Number: NCT06986551
• Lead Sponsor: Cairo University

Brief Summary

To evaluate the remineralization potential of PRG Barrier Coat versus fluoride varnish in white spot lesions in permanent anterior teeth of children.

Detailed Description

Dental caries is a complex disease that is very common among children and is increasing rapidly in low- and middle-income countries. The first sign that the caries process has begun is the appearance of localized areas of enamel demineralization, which manifest as white spot lesions (WSL) with varying degrees of opacity. The approach to managing caries is shifting towards a minimally invasive method, focusing on the prevention, reduction, and reversal of caries in its early stages.

By restoring equilibrium between demineralization and remineralization, WSL can be reversed, unlike cavitated carious lesions. The most effective methods for managing and preventing WSLs are those based on fluoride.

Although fluorides have minimal effect on reducing existing WSL, they do prevent the creation of new WSL. Their impact is limited to the enamel's outermost 50 μm layer and does not encourage remineralization across the demineralized lesion body. Visually, the WSL remains nearly unaltered.

Recently S-PRG filler containing material are available., S-PRG fillers have the ability to release and recharge fluoride , S-PRG fillers releases Al, B, Na, Si and Sr ions Silicate and fluoride strongly induce remineralization of the dentin matrix. Strontium and fluoride also improve the acid resistance of teeth by converting hydroxyapatite to strontium apatite and fluoroapatite. S-PRG fillers become available for use in caries prevention where it is hoped that it would enhance mineralization and reduce acidic attack by oral cariogenic bacteria.

According to they concluded that Varnish containing 40% of S-PRG fillers was more effective than the typical 5% NaF-based product and could be used as a substitute for fluoride for the remineralization of initial enamel caries. According to they concluded that S-PRG Barrier Coat has shown better results for treating white spot lesions after one month interval than 5%NaF.

The unique advantage of PRG product (PRG Barrier Coat, SHOFU) is being light-cured, which serves in facilitating the clinical procedure, offering easier application, and adding excellent self-adhesive properties for durable prolonged protection.

To our knowledge there is limited evidence about the clinical performance of PRG barrier coat versus fluoride varnish on white spot lesions remineralization in permanent anterior teeth of children therefore comes the importance of our clinical study.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-28
• Study Start: 2025-09
• Primary Completion: 2026-05
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Children aged 8-14 years with good health according to the American Society of Anesthesiologists (ASA-I).
• Have at least one white spot lesion with International Caries Detection and Assessment System (ICDAS II) score one or two
• Has not used any remineralizing agent in the former three months.
• Parents who accept to sign informed consent.
• Cooperative patients

Exclusion Criteria

• Patients have caries or restorations in the labial surface.
• Extrinsic or intrinsic stains.
• patients under active orthodontic treatment.
• Uncooperative patient.
• Parents refuse to sign informed consent.
• Medically unfit (other than ASAI).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Remineralization potential ΔE: will be recorded by the differences in color perception by Spectrophotometer	1-3-6 months	The name of measurement: CIELAB parameters, which will record the difference in color perception.; The CIELAB, or CIE L\* a\* b\*, color system represents quantitative relationship of colors on three axes.; The measurement tool: spectrophotometer. (L\*a\*b\* values) L\*: denoted the tooth lightness.; 1. : indicated hues change across the red-green axis.; 2. : represents hues difference across the yellow-blue axis.

Secondary Outcome Measures

Name	Time	Method
ΔE 2000 will be recorded by Spectrophotometer	1-3-6 months	ΔE 2000 will evaluate color difference.; kL, kC, and kH are parametric coefficients that allow users to adjust the weighting of lightness, chroma, and hue differences, respectively.; kL: This coefficient controls the weighting of the lightness difference (ΔL\*) component in the color difference calculation.; kC: This coefficient controls the weighting of the chroma difference (ΔC\*) component.; kH: This coefficient controls the weighting of the hue difference (ΔH\*) component.

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt