NCT06986551

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

Remineralization Potential of PRG Barrier Coat Versus Fluoride Varnish in White Spot Lesions in Permanent Anterior Teeth of Children (A Randomized Controlled Trial)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• White Spot Lesion of Tooth
• Demineralization

Interventions

Type	Name	Description
OTHER	5% NaF fluoride varnish	Before the application of the varnish, teeth were cleaned using a prophylaxis polishing past with a low-speed cone brush in a contra angle low-speed handpiece. It will be dried with air and isolated using cotton rolls. Package will be unpacked, and the application guide will be used to display the contents and mix to avoid the separation of sodium fluoride components. After isolation, a thin layer of the varnish will coat . The participants will be asked to keep their mouths closed to allow the varnish to set in the presence of saliva. Rinsing or suction was not allowed immediately after the application of the varnish. The participants will be asked to avoid consumption of rough and viscid food or hot drinks for two hours after application of the varnish. For the rest of that day, participants will be asked to eat soft food and stop tooth brushing (Ezzeldin et al., 2024).
OTHER	PRG Barrier coat	Before the application of the varnish, teeth were cleaned using a prophylaxis polishing past with a low-speed cone brush in a contra angle low-speed handpiece. It was then dried with air and isolated using cotton rolls. \| P a g e 13 According to the manufacturer's instructions, the application of PRG barrier coat varnish a drop of the active will be mixed with the base using the attached brush. After isolation with cotton rolls, the brush will be used to smear the WSLs with the mix. I will be undisturbed for at least three seconds, then cured for 10 seconds using the visible-light curing unit (Ezzeldin etal.,2024). And there will be no post operative instruction to patient after application (light cured resin material).

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2025-05-23
• Last updated: 2025-05-28

Locations

1 site across 1 country: Egypt