跳至主要内容
临床试验/NCT03480516
NCT03480516已完成不适用

Efficacy of Silver Diamine Fluoride (SDF) and Fluoride Varnish in Arresting and Preventing Dental Caries in Primary School Children: Randomized Controlled Clinical Trial

Khon Kaen University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Number of arrested caries lesion changed from baseline

研究概览

简要总结

Tooth decay is one of the most common chronic infectious disease found in children worldwide and if left untreated, is rapidly progress. Severe tooth decay in children is not only affect child's health and school performance, but also has impact on the family well-being. Oral rehabilitation in children requires time, resources and effort of dental specialists, the child and parents. Caries is a destructive condition of organic and inorganic components of the tooth structures but reversible and most importantly, preventable. Topical fluoride therapy, delivered by dentists has been effectively used to speed up the repair process as well as to strengthen the surface of intact tooth structure. Topical fluoride is available in various preparations. Regular application of sodium fluoride varnish is every three months, by far, considered as effective method in preventing new caries, particularly in the high-risk children. It has the advantage of containing therapeutic concentration of fluoride and ability to flow over and stick to the tooth surface. Whereas silver ion and relatively higher fluoride concentration in Silver Diamine Fluoride (SDF) has been shown to be the most effective in harden the decay, stop the caries progress and eliminate pathogenic bacteria. It can be hypothesize that when use in combination in school children, both reagents might have synergistic effect on arresting existing caries as well as preventing new caries.

详细描述

Fluoride varnish is a good choice to consider. For caries prevention in young children, It has high efficacy in caries prevention.

Fluoride varnish has a high F concentration and prolong contact time with enamel, So it can prevent new caries and remineralize initial enamel caries. Silver diamine fluoride solution is effective in arresting dentine caries. Silver diamine fluoride has high fluoride concentration and contain silver ion. when apply dentine caries or cavitated caries can increase hardness of dentine and arresting caries.

When use in combination, it might enhance, the Efficacy in Arresting and Preventing Dental Caries in children

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
Double (Participant, Investigator)

入排标准

年龄范围
6 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • School children aged 6- 7 years old.
  • Have at least one or more active dentin caries lesions in primary canine/molar.
  • Parents give consent.

排除标准

  • Uncooperative child
  • Allergic reaction to silver or materials containing adhesive.
  • Received topical fluoride 3 months prior to enrollment.
  • Primary carers are unable to response to questionnaire.

结局指标

主要结局

Number of arrested caries lesion changed from baseline

时间窗: 18 months

Number of arrested caries lesion changed from baseline. The arresting dentine caries lesion was evaluated at 18 months after first application. Evaluation criteria included the condition of the hardness and discoloration of carious lesion. The carious lesion was re-categorized as a binary outcome: Dental caries (active/inactive)

次要结局

  • Child satisfaction(18 months)
  • Increasing number of new caries lesion from baseline(18 months)
  • Parental satisfaction(18 months)
  • Cost Effectiveness(18 months)
  • Oral Health-Related Quality of life(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kemporn Kitsahawong

Associate Professor

Khon Kaen University

研究点 (2)

Loading locations...

相似试验