Cost Effectiveness of Sodium Fluoride Varnish Application in Prevention of Dental Caries in School Children Between Age of 6 and 7 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 328
- 主要终点
- change of number of teeth with dental caries at 6months, 1 year and 2 years from the initial presentation
研究概览
简要总结
Fluoride varnish application is universally accepted as a dental caries prevention method. This study was aimed in assessment of clinical outcome and cost effectiveness in using that method in Sri Lankan school children
详细描述
Background Dental caries remains a significant public health problem with multiple factors such as socioeconomic, dietary and microbiological playing a major role as risk factors in initiation and continuation of the disease. It is considered the most common cause of toothache and hospital admissions in young children. Dental caries in school children not only causes pain, but also affects school attendance, parents' work hours, children's ability to eat, play, rest and sleep. Therefore, dental caries when present significantly reduces the health related quality of life of a child.
Improving oral health has been considered as an objective in preventive dental care for children. Therefore the measures taken to prevent dental caries should include bacterial bio film control, dietary counseling, use of fluoride products such as toothpastes, mouth rinses, varnishes, gels and foams, and Casein phosphopeptide (CPP) - amorphous calcium phosphate (ACP) cream and gums and placing resin-based/glass ionomer pit and fissure sealants.) Professional fluoride varnish application has become popular among all methods as variety of studies has discussed its effect in reducing dental caries.
Fluoride varnish use in the U.S. has increased markedly since it was approved by the FDA in 1994. Fluoride varnish's effectiveness in caries prevention, ease of application, and safety give it an advantage over other types of topical fluoride treatments (such as gels and rinses) or other caries management methods. As a result, it is regarded as one of the superior topical fluoride agents for young children. Fluoride varnish also prolongs the contact time between fluoride and tooth surface to reduce caries. Its active ingredient is usually 5% sodium fluoride, or 22,600 ppm fluoride. It also has recently gained much attention in dentistry because the risk of dental fluorosis is found to be minimal.The simplicity of its application makes it very suitable and practical for use in different places and groups.
Justification Despite the availability of free health dental service in Sri Lanka, the prevalence and severity of dental caries among six and seven years old school children stand at a very high level according to the results of national oral health survey as 78% (83/84), 76.4% (94/95) and 65.5% (2002/2003) whereas the dmft is 4.4, 4.1 and 3.6.9 The simplicity of fluoride varnish application makes it very suitable and practical for use in dental clinics and outreach dental services, especially in young children and in other special needs groups.
Up to date to our knowledge, there was no other study carried out on cost effectiveness of fluoride varnish application on teeth in Sri Lankan population. Therefore, the results of the study will be beneficial in implementation and identification of advantages of fluoride varnish application on teeth in young children.
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
- None
盲法说明
interventional group-fluoride varnish application. control group-water
入排标准
- 接受健康志愿者
- 是
入选标准
- •Children with at least one permanent tooth present.
- •Age 6 to 7 years. Children under 6 years of age were enrolled in the study if at least one permanent tooth has erupted.
- •Residing in Kurunegala municipal council region and tap water is consumed (fluoride levels in drinking water is normal).
- •Consent from parental/ primary caregiver/ legal guardian or a family member who is the primary care provider.
排除标准
- •Children with ulcerative gingivitis and stomatitis. (These children were referred for treatment.)
- •No permanent teeth present or stainless steel crowns only
研究组 & 干预措施
fluoride varnish application
intervention; fluoride varnish application (with 5% Sodium fluoride varnish application on teeth)
干预措施: 5% sodium fluoride varnish (Drug)
control group
application of water on teeth in the control group
干预措施: WATER ON TEETH (Other)
结局指标
主要结局
change of number of teeth with dental caries at 6months, 1 year and 2 years from the initial presentation
时间窗: 2years
change of number of new dental caries prevented using sodium fluoride varnish application at 6months, 1 year and 2years from the initial presentation for the study
次要结局
未报告次要终点
研究者
Dr. RM Jayasinghe
Principal investigator
University of Peradeniya
