None listed
Conditions
Brief summary
The objective of this two-year randomized placebo-controlled trial was to assess whether the application of Fluoride varnish in preschool children at six-months intervals decreases the number of new caries lesions in their primary dentition. We also investigated whether this procedure is safe and well-accepted by the children themselves and their caretakers. At the beginning of the study, two hundred 1 to 4-year old children were allocated to the test (Fluoride varnish) or control (Placebo varnish) groups. The participants, their caretakers, examining dentists and the clinical staff did not know to each group each child was allocated. After the first varnish application, 183 children's caretakers were interviewed by telephone in order to know if they or their children had any complaints regarding the varnish application. Two years later, 181 children showed-up for dental examination (89 in the test group and 92 in the placebo group).
Interventions
Fluoride varnish (5% Sodium Fluoride) was applied every six months, during two years, to the primary teeth of the children who were randomly allocated to the test group.
Sponsors
Branca Heloisa de Oliveira
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Years to 4 Years
Healthy volunteers
Yes
Inclusion criteria
Living in Rio de Janeiro city for at least one year and planning to reside in the city for the following two years, having a fixed address, and owning a telephone or having a close relative who owned a telephone.
Exclusion criteria
Having received a professional fluoride application in the previous six months, presenting more than ten dentine caries lesions, having a dental abscess or a systemic disease that could be aggravated by a dental problem (i.e., diabetes, rheumatic fever, heart disease or HIV infection).
Outcome results
None listed