Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- reduction of the size of the caries lesion
研究概览
简要总结
The study hypothesis is the difference in therapeutic effect of two varnish formulations (G1 = NaF, 2.26%F, G2 = NaF, 2.71% F + CaF2). These products are commercially available in the Brazilian and international market and they are used for dental caries as white spot lesions control.
详细描述
The aim of this study was to evaluate the therapeutic effect of two varnish formulations (G1 = NaF, 2.26%F, G2 = NaF, 2.71% F + CaF2) on the remineralization of white spot lesions (WSL). The sample was composed of 15 (7- to 12-year-old) children with 45 active WSL in anterior permanent teeth. The children were randomly divided in two groups providing 22 lesions for G1 and 23 for G2. The children were submitted to weekly varnish applications 4 times. The WSL were evaluated twice: baseline and on week 4. Maximum lesion dimensions (mesial-distal and incisal-gingival) were measured in millimeters and classified in four grades of size. WSL were also recorded assessing lesion activity by one calibrated examiner. The Pearson chi-square and Fisher's exact tests were used (P < 0.01). WSL reductions were observed in both varnish groups (Chi-square= 0.15, d.f.=1, P=0.90); and with similar magnitude (in mm): 1.19 and 1.29 for G1 and G2, respectively. Thirty-six WLS (15 in G1 and 26 in G2) were classified as inactive in week 4 reaching an overall value of 80%. No difference was observed between G1 and G2 regarding activity scores (Fisher's exact test, p > 0.01). It can be concluded that after 4 applications the two varnish formulations tested produced similar clinical effects indicating the reduction and the control of carious activity in most WSL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •regular hygiene habits (brushing teeth everyday)
- •registered in public schools
排除标准
- •dental caries such as small cavities or restorations in the target teeth (permanent anterior teeth)
- •development enamel alterations (hypoplasia, fluorosis) or periodontal disease
- •children using orthodontic devices
- •under medical treatment
- •taking any kind of medicine
- •no informed consent form signed
研究组 & 干预措施
G1
NaF (sodium fluoride varnish) with 2.26% of fluoride
干预措施: sodium fluoride (Drug)
G2
NaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride)
干预措施: sodium fluoride calcium fluoride (Drug)
结局指标
主要结局
reduction of the size of the caries lesion
时间窗: 4 weeks
次要结局
- Inactivation of carious lesions(4 weeks)