Remineralization Potential of PRG Barrier Coat Versus Fluoride Varnish in White Spot Lesions in Permanent Anterior Teeth of Children (A Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Remineralization potential ΔE: will be recorded by the differences in color perception by Spectrophotometer
研究概览
简要总结
To evaluate the remineralization potential of PRG Barrier Coat versus fluoride varnish in white spot lesions in permanent anterior teeth of children.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The blinding of the operator is not possible due to the nature of the material used. Trial participants, outcome assessors and statisticians will be blinded.
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
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 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).
干预措施: PRG Barrier coat (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
干预措施: 5% NaF fluoride varnish (Other)
结局指标
主要结局
Remineralization potential ΔE: will be recorded by the differences in color perception by Spectrophotometer
时间窗: 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.
次要结局
- ΔE 2000 will be recorded by Spectrophotometer(1-3-6 months)
研究者
Hanaa Hamdy Mohamed Fathy Mahmoud Rady
dentist
Cairo University