Remineralization Potential of PRG Barrier Coat Versus Flu... | NCT06986551

Status Module

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRG Barrier coat	Experimental	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 According to the manufacturer's instructions, for 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. And there will be no postoperative instruction to the patient after application (light-cured resin material).	Other: PRG Barrier coat
5% NaF fluoride varnish	Active Comparator	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: 5% NaF fluoride varnish

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5% NaF fluoride varnish	Other	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Remineralization potential ΔE: will be recorded by the differences in color perception by Spectrophotometer	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. (Lab values) L*: denoted the tooth lightness. : indicated hues change across the red-green axis. : represents hues difference across the yellow-blue axis.	1-3-6 months

Secondary Outcomes

Measure	Description	Time Frame
ΔE 2000 will be recorded by Spectrophotometer	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.

Eligibility Module

Name	Role	Phone	Extension	Email
Hanaa H.M.F.M. Rady, Master's student	Contact	+201006257884		Hanaa.hamdy@dentistry.cu.edu.eg

Name	Affiliation	Role
Hala M. Abbas, PhD	Head of Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University	Study Director

References Module

Citations

PubMed Identifier	Type	Citation
	Background	Ezzeldin, N., Wahied, D. M., Atef, R., & Mustafa, S. (2024). Clinical evaluation of PRG Barrier coat versus fluoride varnish on the color improvement of white spot lesions in permanent teeth of children: A randomized controlled trial. MSA Dental Journal. https://msadj.journals.ekb.eg/
31571787	Background	Arifa MK, Ephraim R, Rajamani T. Recent Advances in Dental Hard Tissue Remineralization: A Review of Literature. Int J Clin Pediatr Dent. 2019 Mar-Apr;12(2):139-144. doi: 10.5005/jp-journals-10005-1603.
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