Overview

This trial is active, not recruiting.

Condition dental caries
Treatment fluoride varnish 22600ppm
Phase phase 1/phase 2
Sponsor University of Peradeniya
Start date August 2016
End date July 2018
Trial size 320 participants
Trial identifier NCT02877888, FRC/FDS/UOP-2014/25

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
intervention: drug :fluoride varnish 22600ppm topical application every 6 months for a total period of 2 years
fluoride varnish 22600ppm 5% duraphat
topical application on teeth every 6months
(No Intervention)
placebo:use of routine dental advice

Primary Outcomes

Measure
number of caries prevented using the International Caries Detection and Assessment System (ICDAS)
time frame: every 6 months for 2 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 6 years up to 7 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - Children with ulcerative gingivitis and stomatitis. (These children will be referred for treatment.) - No permanent teeth present or stainless steel crowns only.

Additional Information

Official title Cost Effectiveness of Sodium Fluoride Varnish Application in Prevention of Dental Caries in School Children Between Age of 6 and 7 Years
Description 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 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 in Sri Lanka stand at a very high level according to the results of national oral health survey in 1983/84, 94/95 and 2002/2003. The prevalence is 78% (83/84), 76.4% (94/95) and 65.5% (2002/2003) whereas the dmft is 4.4, 4.1 and 3.6. 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. Up to date there is 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. Aim The main objective of this study is to evaluate the cost effectiveness of six monthly application of sodium fluoride varnish in prevention of dental caries in deciduous teeth, permanent incisors and molars in children between six and seven years in Sri Lanka. The specific objective is: 1. To find out the association between dental caries and the social status of the child (e.g. mother's education, father's education, monthly family income etc.) Methods Study Type: Interventional 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 fluoride varnish application group will receive fluoride varnish professionally applied after prophylaxis every 6 months combined with counselling on maintenance of oral hygiene and diet for a period of 2 years. 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. For evaluation and comparison, all the collected data will be subjected to statistical analysis. Both varnish and control groups will be subjected to use of fluoride tooth paste of 1000ppm. The control group will be subjected to counselling on maintenance of oral hygiene and diet. During this period, each school will be visited four times at six months 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. Trained interviewers will collect data on oral health habits and sociodemographic characteristics from the children. Information on the child's diet will be collected through a 4-day food frequency diary. 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 in terms of number of caries prevented. The number of new caries in the usual care and intervention group will be calculated after the completion of the study. The intervention and usual care group will be presented with their demographics and socioeconomic data. The costs for intervention will be estimated. The cost of treatment for caries will be estimated for intervention and non-Intervention groups. The costs will be estimated for the dental material, time for human resources and indirect costs. Quality of life increments will be measured with CHU-9D preference based instrument. Quality Adjusted Life Years (QALYs) will be calculated as a secondary outcome measure. A Markov model will be built to assess the cost effectiveness of the intervention in the perspective of the health system and the society. The results will be presented as cost per caries prevented and cost per QALY prevented.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Peradeniya.