Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries: A Randomized Controlled Trial

Dental Caries Clinical Trial

Official title:

Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries in Non-fluoridated Areas: A 24-month Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742038
• Other study ID #: FON11-0002
• Secondary ID: SA1154
• Status: Completed
• Phase: N/A
• First received: April 13, 2016
• Last updated: October 26, 2017
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2017
• Source: Universidad de la Frontera
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Triple-blind randomized controlled trial with two parallel arms conducted between 2012 and 2014. Children 2-3 years old, from 28 rural public preschools, located in low socioeconomic areas of Chile were invited to participate. Oral health education component was given to children, parents and educators, twice yearly. A new toothbrush and toothpaste for each child was delivered to the parents at baseline and in each of the follow-up visits. The experimental group was treated with fluoride varnish every six months while the control group received placebo applications. 277 preschoolers (2 to 3 years) Main outcome: Number of Caries Incident Cases, increment dmft index

Description:

Triple-blind randomized controlled trial with two parallel arms conducted between 2012 and 2014. Children 2-3 years old, from 28 rural public preschools, located in low socioeconomic areas of Chile were invited to participate. Oral health education component was given to children, parents and educators, twice yearly. A new toothbrush and toothpaste for each child was delivered to the parents at baseline and in each of the follow-up visits. The experimental group was treated with fluoride varnish every six months while the control group received placebo applications. A trained, calibrated dentists blinded to treatment arm performed a visual-tactile dental assessment at 6, 12, 18 and 24 months. The number of incidents children with caries were recollected as the number of caries during the follow-up visits.

Nº of participant/ centres: 277 preschoolers (2 to 3 years) of 28 public preschools in non-fluoridated areas.

Main outcome: Number of Caries Incident Cases, increment dmft index

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 47 Months

Eligibility

Inclusion Criteria:

• Children between 24 an 47 months, free of caries, preschooler of a public centre and living in a non-fluoridated community.

Exclusion Criteria:

• Children compromised medically, or with developmental or learning disabilities, or with a temporary residence or with dental developmental anomalies.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Fluoride varnish plus education
Biannual varnish every 6 month/ 24 months plus educational component

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de la Frontera

References & Publications (1)

Muñoz-Millán P, Zaror C, Espinoza-Espinoza G, Vergara-Gonzalez C, Muñoz S, Atala-Acevedo C, Martínez-Zapata MJ. Effectiveness of fluoride varnish in preventing early childhood caries in rural areas without access to fluoridated drinking water: A randomize — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental Caries	Number of caries and incident cases	24 months
Secondary	Caries increment	caries increment measured by the amount of change in dmfs index from baseline	24 months