Randomized Trial on Resin Infiltration in Deciduous Teeth
Condition: White Spot Lesions; Caries
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      -  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.
    

Intervention name(s): resin infiltration; fluoride varnish
Intervention type(s): Other; Other
Intervention description(s): The test group (41 children) had caries lesions treated with the resin infiltration technique using Icon by the following procedure: rubber dam applying; etching with 15% hydrochloric acid for 120 s; surface rinsing and drying; dehydrating with ethanol for 30 s and air-drying; infiltrant resin infiltration with a syringe for 180 s; resin polymerization (polymerized by blue light - wavelength of 450 nm and intensity of 800mW/cm2; resin reapplication for 60 s and polymerization; rubber dam removal, and working on the infiltrated lesion with polishing rubbers. After the procedure fluoride varnish was applied.; All tooth surfaces including WSL treated with fluoride varnish (2,26% F, Duraphat ® Colgate Palmolive, Hamburg, Germany).
Other intervention name(s): Icon DMG Germany; Duraphat Colgate Palmolive Germany; Duraphat Colgate Palmolive, Hamburg, Germany
Intervention MeSH terms: Listerine; Fluorides; Fluorides, Topical; Sodium Fluoride; Sodium fluoride topical preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: resin infiltration; randomized clinical trial; fluoride varnish; caries lesion; deciduous teeth