Clinical trial NCT01881100: Randomized Trial on Resin Infiltration in Deciduous Teeth
Official title: Randomized Clinical Trial on Resin Infiltration Versus Fluoride Varnish Treatment of Early Smooth-surface Caries Lesions in Deciduous Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesions
Caries
Keywords: resin infiltration
randomized clinical trial
fluoride varnish
caries lesion
deciduous teeth
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth versus fluoride varnish therapy only.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Dorota Olczak-Kowalczyk
state: Warsaw, 18 Miodowa St
Study officials:
affiliation: Warsaw Medical University, 61 Żwirki i Wigury St.,02-091Warsaw
name: Dorota Olczak-Kowalczyk, Ass. Prof.
role: STUDY_DIRECTOR
affiliation: Warsaw Medical University, Poland
name: Dorota Olczak-Kowalczyk, Ass.Prof.
role: STUDY_DIRECTOR
References: