Randomized Clinical Trial on Resin Infiltration Versus Fluoride Varnish Treatment of Early Smooth-surface Caries Lesions in Deciduous Teeth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 81
- Locations
- 2
- Primary Endpoint
- Resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth versus fluoride varnish therapy only.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Months to 71 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •at least two active smooth-surface caries lesions in deciduous teeth (ICDAS II code 2)
- •a written consent of parents/ guardians for participation in the research study
Exclusion Criteria
- •age above 5.9 years
- •systematic disease
- •cavitated lesions
- •enamel defects
- •current participation in another study
- •a planned change of residence within one year
Outcomes
Primary Outcomes
Resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth versus fluoride varnish therapy only.
Time Frame: one year
The condition of treated white spot lesions (WSL) were scored using the Nyvad et al. system (17): I-WSL (Inactive WSL) - inactive spot lesion, when surface was becoming smooth, hard and glossy; S -WSL (Sound WSL) - invisible spot lesion taking the appearance of healthy enamel with proper translucency level and surface texture. Active enamel lesions and assessment scores 3-6 according to ICDAS II within a year were considered as decayed (D-Enamel/Dental cavity). Treatment was considered successful when lesions did not progress (I-WSL or S-WSL); unsuccessful when lesions remained active and enamel underwent erosion - i.e. caries occurred (D).
Secondary Outcomes
No secondary outcomes reported
Investigators
Anna Turska Szybka
Phd,MD
Medical University of Warsaw