跳至主要内容
临床试验/NCT01500187
NCT01500187已完成不适用

Fluoride Varnish Application for Treatment of White Spot Lesion After Fixed Orthodontic Treatment. A Pilot Study.

Solventum US LLC2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2012年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison

研究概览

简要总结

Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that can occur around the edge of fixed orthodontic brackets.

详细描述

To determine the efficacy of 5% sodium fluoride varnish with tricalcium phosphate in reverting white spot lesions after fixed orthodontic treatment, compared with a fluoride gel.

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
None

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • no systemic disease
  • has completed fixed orthodontic treatment, brackets debonded
  • has at least two teeth with whitre spot lesions
  • has received conventional periodontal therapy after orthodontic tretament

排除标准

  • presence of enamel hypoplasia or dental fluorosis
  • presence of tetracycline pigmentation
  • periodontal pocketing of 3mm or greater
  • taking antibiotics
  • presence of carious cavities
  • allergy to fluoride gel / varnish being used in study

研究组 & 干预措施

Pediagel

Active Comparator

1.23% Acidulated Phosphate Fluoride Gel

干预措施: Pediagel (Device)

3M Vanish Varnish

Experimental

5% sodium fluoride varnish

干预措施: Vanish Varnish (Device)

结局指标

主要结局

DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison

时间窗: Baseline, Three and Six Month

Outcome of fluoride varnish or gel application to white spot lesions as measured by DIAGNOdent device after orthodontic debonding. Values shown represent the mean DIAGNOdent reading. The DIAGNOdent scale spans values from 0 to 30+ where larger values indicate higher levels of demineralization.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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