Remineralization Potential of PRG Barrier Coat Versus Fluoride Varnish in White Spot Lesions in Permanent Anterior Teeth of Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 5% NaF fluoride varnish, PRG Barrier coat.
- Who it may be relevant to
- Registry conditions: White Spot Lesion of Tooth, Demineralization. Basic parameters: 8 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Interventions
- 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 - 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
Primary outcome measures
- Remineralization potential ΔE: will be recorded by the differences in color perception by Spectrophotometer [Time frame: 1-3-6 months]
Secondary outcome measures (1)
- ΔE 2000 will be recorded by Spectrophotometer [Time frame: 1-3-6 months]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Faculty of Dentistry, Cairo University — Cairo
Publications
- 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/
- 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. PMID 31571787
- 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. PMID 23817057
- 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. PMID 31514356
Identifiers
NCT: NCT06986551 · PRG Barrier Remineralization