Clinical trial NCT06986551: Remineralization Potential of PRG Barrier Coat Versus Fluoride Varnish in White Spot Lesions in Permanent Anterior Teeth of Children
Official title: Remineralization Potential of PRG Barrier Coat Versus Fluoride Varnish in White Spot Lesions in Permanent Anterior Teeth of Children (A Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: White Spot Lesion of Tooth
Demineralization
Keywords: PRG Barrier Coat
white spot lesion
Fluoride Varnish
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 78
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A random sequence will be generated by the assistant supervisor using the online form Using four-folded numbered paper on which remineralizing agent will be written contained in the closed white envelope When a patient agrees to participate in the trial, an envelope will be drawn by co-supervisor and name, telephone number and patient's I.D. will be written on it. Those selected envelopes will be opened at the treatment visit after taking baseline clinical data to choose which material should be used. Randomization and allocation concealment will be performed by the co-supervisor to avoid selection bias
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Remineralization potential ΔE: will be recorded by the differences in color perception by Spectrophotometer
timeFrame: 1-3-6 months
Secondary outcomes:
measure: ΔE 2000 will be recorded by Spectrophotometer
timeFrame: 1-3-6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Head of Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
name: Hala M. Abbas, PhD
role: STUDY_DIRECTOR
References:
citation: 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/
citation: 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.
citation: Amaechi BT, van Loveren C. Fluorides and non-fluoride remineralization systems. Monogr Oral Sci. 2013;23:15-26. doi: 10.1159/000350458. Epub 2013 Jun 28.
citation: Okamoto M, Ali M, Komichi S, Watanabe M, Huang H, Ito Y, Miura J, Hirose Y, Mizuhira M, Takahashi Y, Okuzaki D, Kawabata S, Imazato S, Hayashi M. Surface Pre-Reacted Glass Filler Contributes to Tertiary Dentin Formation through a Mechanism Different Than That of Hydraulic Calcium-Silicate Cement. J Clin Med. 2019 Sep 11;8(9):1440. doi: 10.3390/jcm8091440.