Clinical Trial: Cost Effectiveness of Fluoride Varnish in Prevention of Dental Caries in School Children
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Cost Effectiveness of Sodium Fluoride Varnish Application in Prevention of Dental Caries in School Children Between Age of 6 and 7 Years
Brief Summary:
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
Detailed Summary:
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 recentl
Sponsor: University of Peradeniya
Current Primary Outcome: number of caries prevented using the International Caries Detection and Assessment System (ICDAS) [ Time Frame: every 6 months for 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: questionnaire to find out social status of the child (e.g. mother's education, father's education, monthly family income etc.) [ Time Frame: end of the study: 2 years ]
Original Secondary Outcome: Same as current
Information By: University of Peradeniya
Dates:
Date Received: August 11, 2016
Date Started: August 2016
Date Completion: August 2018
Last Updated: October 29, 2016
Last Verified: October 2016
