NCT03571815

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

1.9 years

First QC Date

May 3, 2018

Last Update Submit

June 27, 2018

Conditions

Dental Caries in Children

Keywords

Fluoride varnishclinical trialdental caries

Outcome Measures

Primary Outcomes (1)

  • 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

    2years

Study Arms (2)

fluoride varnish application

EXPERIMENTAL

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

Drug: 5% sodium fluoride varnish

control group

PLACEBO COMPARATOR

application of water on teeth in the control group

Other: WATER ON TEETH

Interventions

5% sodium fluoride varnishDRUG

application of sodium fluoride varnish on teeth

Also known as: sodium fluoride varnish
fluoride varnish application
WATER ON TEETHOTHER

control group

control group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Interventions

Bifluorid 12

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
interventional group-fluoride varnish application. control group-water
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 3, 2018

First Posted

June 28, 2018

Study Start

January 2, 2015

Primary Completion

December 1, 2016

Study Completion

July 2, 2017

Last Updated

June 29, 2018

Record last verified: 2018-06