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Cost Effectiveness of Sodium Fluoride Varnish in Prevention of Dental Caries in School Children

Primary Purpose

Dental Caries in Children

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
5% sodium fluoride varnish
WATER ON TEETH
Sponsored by
University of Peradeniya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries in Children focused on measuring Fluoride varnish, clinical trial, dental caries

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Accepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Children with ulcerative gingivitis and stomatitis. (These children were referred for treatment.)
  • No permanent teeth present or stainless steel crowns only

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    fluoride varnish application

    control group

    Arm Description

    intervention; fluoride varnish application (with 5% Sodium fluoride varnish application on teeth)

    application of water on teeth in the control group

    Outcomes

    Primary Outcome Measures

    change of number of teeth with dental caries at 6months, 1 year and 2 years from the initial presentation
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 3, 2018
    Last Updated
    June 27, 2018
    Sponsor
    University of Peradeniya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03571815
    Brief Title
    Cost Effectiveness of Sodium Fluoride Varnish in Prevention of Dental Caries in School Children
    Official Title
    Cost Effectiveness of Sodium Fluoride Varnish Application in Prevention of Dental Caries in School Children Between Age of 6 and 7 Years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2, 2015 (Actual)
    Primary Completion Date
    December 1, 2016 (Actual)
    Study Completion Date
    July 2, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Peradeniya

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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. Aim The main objective of this study was 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 was a double-blind, randomized controlled trial. A sample of school children (6-7 years) were randomized into varnish and control groups. All the children received routine caries preventive measures of oral hygiene instructions, dietary advice and professional cleaning. Children in fluoride varnish application group received fluoride varnish professionally applied after prophylaxis every 6 months combined with counseling on maintenance of oral hygiene and diet for a period of 2 years. Clinical examinations of all children were performed at the beginning of the study and 1 year and 2 years later. All the caries at the dentinal level of both groups were stabilized with temporary restorations at the beginning. For evaluation and comparison, all the collected data was subjected to statistical analysis. Both varnish and control groups were subjected to use of fluoride tooth paste of 1000ppm. The control group was subjected to counseling on maintenance of oral hygiene and diet. During this period, the team visited each school four times at six months interval for recruitment, dental examinations, and fluoride varnish applications. Recruited children were randomly assigned to either a treatment (5% Sodium Fluoride varnish) or a control group. Trained interviewers collected data on oral health habits and sociodemographic characteristics of the children. Information on the child's diet was collected through a 4-day food frequency diary. Caries examinations were 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 were evaluated and compared at the end of the study. The sample size was calculated as 160 each arm to detect 5% caries change with 80% power. Analysis The effect of intervention was measured in terms of number of caries prevented. The number of new caries in the usual care and intervention group was calculated after the completion of the study. The demographic and socioeconomic data of the intervention and usual care group were collected. The costs for intervention were estimated. The cost of treatment for caries was estimated for intervention and non-Intervention groups. The costs for the dental material, time for human resources and indirect costs were also calculated. The results were presented as cost per caries prevented.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries in Children
    Keywords
    Fluoride varnish, clinical trial, dental caries

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Masking Description
    interventional group-fluoride varnish application. control group-water
    Allocation
    Randomized
    Enrollment
    328 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    fluoride varnish application
    Arm Type
    Experimental
    Arm Description
    intervention; fluoride varnish application (with 5% Sodium fluoride varnish application on teeth)
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    application of water on teeth in the control group
    Intervention Type
    Drug
    Intervention Name(s)
    5% sodium fluoride varnish
    Other Intervention Name(s)
    sodium fluoride varnish
    Intervention Description
    application of sodium fluoride varnish on teeth
    Intervention Type
    Other
    Intervention Name(s)
    WATER ON TEETH
    Intervention Description
    control group
    Primary Outcome Measure Information:
    Title
    change of number of teeth with dental caries at 6months, 1 year and 2 years from the initial presentation
    Description
    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
    Time Frame
    2years

    10. Eligibility

    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Children with ulcerative gingivitis and stomatitis. (These children were referred for treatment.) No permanent teeth present or stainless steel crowns only

    12. IPD Sharing Statement

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    Cost Effectiveness of Sodium Fluoride Varnish in Prevention of Dental Caries in School Children

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