Caries Clinical Trial
Official title:
Randomized Clinical Trial on Resin Infiltration Versus Fluoride Varnish Treatment of Early Smooth-surface Caries Lesions in Deciduous Teeth
It was hypothesized that resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth reduce considerably the progression of treated caries lesions, compared to fluoride varnish therapy only.
- To determine the number of patients, sample size was based on data from studies
assessing fluoride varnish efficacy in children with deciduous teeth (progression of
caries reduction by 33 %)(95% CI, from 19 to 48%, P<0.0001); (α = 0.05; power = 80%;
chi-square test2). The calculated sample size was 60 children and 120 white spot
lesions. The initially planned number of participants was increased by expected 20%
drop-out after 1 year, at least 72 children; the minimal number of treated active
caries lesions amounted to 144.
- Participants were allocated to the "test" and to the "control" group, respectively, by
computer-generated randomly permuted blocks using package blockrand in R statistical
software, sealed in envelopes.
- The children were re-examined clinically by the same 2 examiners as at baseline
evaluation.
- Statistical analyses were performed using statistical software STATISTICA 10
(StatSoft), the level of significance was set at 0.05. Intra-examiner reliability was
assessed by kappa statistics.
- To compare average values between two independent groups U Mann-Whitney test was used
(for e.g. to compare experimental group with the control one); Wilcoxon signed-rank
test was used for paired samples (for e.g. to compare first measurement with final
measurement for experimental group). Comparison of fractions was conducted using
Pearson's chi-square test of independence and Z test. The 95% confidence intervals were
calculated on the basis of normal approximation.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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