A Randomised Controlled Trial to Measure Effectiveness of Sodium Fluoride Varnish to Prevent Dental Caries in School Children Between Age of 6 and 7 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 320
- 主要终点
- number of caries prevented in the intervention and control gropus
研究概览
简要总结
Despite the availability of free health dental service in Sri Lanka, the prevalence and severity of dental caries among 6year old school children stand at a very high level according to the results of national oral health survey in 1983/84, 94/95 and 2002/2003. Professional fluoride varnish application has become popular as variety of studies has found that it is an efficient method in reducing dental caries. The simplicity of its application makes it very suitable and practical for use in dental clinics and outreach dental services, especially in young children.
Aim of this study is to evaluate the cost effectiveness of 6 monthly application of sodium fluoride varnish in prevention of dental caries in permanent incisors and molars in children between 6 and 7 years in a suburban setting in Sri Lanka. This will be a double-blind, randomized controlled trial. A sample of school children (6-7 years) will be randomized into varnish and control groups. All the children will receive routine caries preventive measures of oral hygiene instructions, dietary advice and professional cleaning. Children in varnish group will receive fluoride varnish professionally applied after prophylaxis every 6 months. Clinical examinations of all children will be performed at the beginning of the study and 1 year and 2 years later. All the caries at the dentinal level of both groups will be stabilized with temporary restorations at the beginning. During this period, each school will be visited four times at 6-month interval for recruitment, dental examinations, and fluoride varnish applications. Recruited children will be randomly assigned to either a treatment (5% NaF varnish) or a control group. Caries examinations will be conducted using the International Caries Detection and Assessment System (ICDAS). The cost for the dental team's school visits; cost involved in the treatment of dental caries throughout the course of the study in both groups will be evaluated and compared at the end of the study. The sample size is calculated as 160 each arm to detect 5% caries change with 80% power. Analysis The effect of intervention will be measured by number of caries prevented. New caries in the usual care and intervention group will be calculated after the completion of the study. The costs for intervention will be estimated. The costs will be estimated for the dental material, time for human resources and indirect costs.
详细描述
Background
Dental caries remains a significant public health problem with socioeconomic, dietary and microbiological factors playing a major role as risk factors in initiation and progression of the disease. It is the most common cause of toothache and hospital admissions in young children. Dental caries in school children not only causes pain, but also impacts school attendance, parents' work hours, children's ability to eat, play and sleep. Therefore, dental caries when present significantly reduces the health related quality of life of a child.
Evidence-based studies indicate oral health prevention is cost-effective and saves children from pain and lost days of school.Therefore the measures taken to prevent the develop¬ment of dental caries could include bacterial biofilm control, dietary counselling, fluoride toothpastes, mouth rinses, varnishes, gels and foams, and casein-derived remineralisation pastes and placing resin-based/glass-ionomer pit and fissure sealants. ) Professional fluoride varnish application has become popular as variety of studies has discussed its effect in reducing dental caries.
Fluoride varnish was incorporated into clinical dentistry to reduce caries; its use in the U.S. has increased progressively 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 also minimal.The simplicity of its 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.
Justification
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 7 Years（Child）
- 性别
- All
- 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 may be 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).
- •Parental consent must be provided. If the parent is not the primary caregiver, a legal guardian or a family member who is the primary care provider must sign the consent form.
排除标准
- •Children with ulcerative gingivitis and stomatitis. (These children will be referred for treatment.)
- •No permanent teeth present or stainless steel crowns only.
研究组 & 干预措施
drug fluoride varnish /strength 22600ppm
intervention: drug :fluoride varnish 22600ppm topical application every 6 months for a total period of 2 years
干预措施: fluoride varnish 22600ppm (Drug)
结局指标
主要结局
number of caries prevented in the intervention and control gropus
时间窗: every 6 months for 2 years
Association between sodium fluoride varnish application and the mean number of new dental caries atdifferent points are shown in table 3. Table 3: Association between sodium fluoride varnish application and new dental caries at different time points Period Mean number of dental caries in the Intervention Group Mean number of dental caries in the Control Group p value# 2015 May 0.94 1.79 \<0.001 2015 Dec 1.69 1.77 \<0.001 2016 Nov 1.50 1.97 \<0.001 #Mann-Whitney U test
Relationship of quality of life of children with dental caries and without dental caries
时间窗: at the beginning of study after examination
The total sample consisted of 321 students, with 161 and 162 in control and intervention groups respectively. Mean number of caries was significantly high among those who had difficulty in chewing, difficulty in vigorous chewing, difficulty in taking hot or cold food. Percentage of students with at least one dental caries at the beginning of the study was compared between different variables. If a student had at least one tooth with dental caries, was taken as positive for dental caries. Of the total population 115 (65.7%) of the students in the 6 age group had at least one tooth with dental caries and equal proportion was found among those who were more than six years as well. Difficulty in chewing (\<0.001), difficulty chewing vigorously (\<0.001), difficulty taking cold or hot food (\<0.001) and difficulty taking sweets (0.034) were experienced more by the students who had at least one dental caries.
次要结局
- Independent association between vanish intervention and new dental caries(every 6 months for 2 years)
研究者
Dr. RM Jayasinghe
senior lecturer
University of Peradeniya