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Trial record 2 of 1236 for:    tooth decay

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02877888
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : December 12, 2018
Queensland University of Technology
Information provided by (Responsible Party):
Dr. RM Jayasinghe, University of Peradeniya

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 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.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: fluoride varnish 22600ppm Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: 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
Actual Study Start Date : August 2016
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: drug fluoride varnish /strength 22600ppm
intervention: drug :fluoride varnish 22600ppm topical application every 6 months for a total period of 2 years
Drug: fluoride varnish 22600ppm
topical application on teeth every 6months
Other Name: 5% duraphat

No Intervention: placebo comparator
placebo:use of routine dental advice

Primary Outcome Measures :
  1. number of caries prevented in the intervention and control gropus [ Time Frame: 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

  2. Relationship of quality of life of children with dental caries and without dental caries [ Time Frame: 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.

Secondary Outcome Measures :
  1. Independent association between vanish intervention and new dental caries [ Time Frame: every 6 months for 2 years ]

    To assess the independent effect of the intervention on development of new dental caries, when other factors are controlled, multiple linear regression was applied. Application of vanish was significantly associated with less number of new dental caries at two time points (May 2015 and Nov 2016) of the survey.

    Period β coefficient 95% CI p value May 2015 Intervention -0.84 -1.24 - -0.45 <0.001 Control 1 Dec 2015 Intervention 0.09 -0.45 - 0.64 0.733 Control 1 Nov 2016 Intervention -0.49 -1.0 - -0.28 0.043 Control 1

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Ages Eligible for Study:   6 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Publications of Results:
Other Publications:
AAPD. Policy on early childhood caries (ECC): classifications, consequences, and preventive strategies. Pediatr Dent 2012; 34:50-2
Bali RK, Mathur VB, Talwar PP, Chanana HB. National Oral Health Survey and Fluoride Mapping, 2002-2003, India. Delhi: Dental Council of India; 2004
Child Dental Health Survey 2013: England, Wales and Nothern Ireland 2013
State Oral Health Surveys. Centers for Disease Control and Prevention 2018

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Responsible Party: Dr. RM Jayasinghe, senior lecturer, University of Peradeniya Identifier: NCT02877888     History of Changes
Other Study ID Numbers: FRC/FDS/UOP-2014/25
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dr. RM Jayasinghe, University of Peradeniya:
cost effectiveness
fluoride varnish
dental caries
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs