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Trial record 1 of 292 for:    Sodium Fluoride OR Duraphat
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Cost Effectiveness of Sodium Fluoride Varnish in Prevention of Dental Caries in School Children

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ClinicalTrials.gov Identifier: NCT03571815
Recruitment Status : Completed
First Posted : June 28, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. RM Jayasinghe, University of Peradeniya

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

Condition or disease Intervention/treatment Phase
Dental Caries in Children Drug: 5% sodium fluoride varnish Other: WATER ON TEETH Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: interventional group-fluoride varnish application. control group-water
Primary Purpose: Prevention
Official Title: Cost Effectiveness of Sodium Fluoride Varnish Application in Prevention of Dental Caries in School Children Between Age of 6 and 7 Years
Actual Study Start Date : January 2, 2015
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : July 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: fluoride varnish application
intervention; fluoride varnish application (with 5% Sodium fluoride varnish application on teeth)
Drug: 5% sodium fluoride varnish
application of sodium fluoride varnish on teeth
Other Name: sodium fluoride varnish

Placebo Comparator: control group
application of water on teeth in the control group
Other: WATER ON TEETH
control group




Primary Outcome Measures :
  1. change of number of teeth with dental caries at 6months, 1 year and 2 years from the initial presentation [ Time Frame: 2years ]
    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



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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Dr. RM Jayasinghe, Principal investigator, University of Peradeniya
ClinicalTrials.gov Identifier: NCT03571815     History of Changes
Other Study ID Numbers: UPeradeniya
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018

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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
Keywords provided by Dr. RM Jayasinghe, University of Peradeniya:
Fluoride varnish
clinical trial
dental caries
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Fluorides, Topical
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents