Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Cost Effectiveness of Sodium 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: NCT03571815
Recruitment Status : Completed
First Posted : June 28, 2018
Last Update Posted : June 29, 2018
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

Show Show detailed description

Layout table for study information
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
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
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 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

Layout table for additonal information
Responsible Party: Dr. RM Jayasinghe, Principal investigator, University of Peradeniya Identifier: NCT03571815    
Other Study ID Numbers: UPeradeniya
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018

Layout table for additional information
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:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Sodium Fluoride
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents