Randomized Trial on Resin Infiltration in Deciduous Teeth (infiltration)

Medical University of Warsaw

Status: Completed

Conditions: White Spot Lesions; Caries

Treatments: Other: resin infiltration; Other: fluoride varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT01881100

WarsawMU (Other Identifier)

No sponsor ID

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 71 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

resin infiltration

Experimental group

Description:

The test group (41 children) had caries lesions treated with the infiltration technique using Icon (DMG, Hamburg, Germany) and fluoride varnish (Duraphat, Colgate Palmolive, Hamburg, Germany)at baseline evaluation. Fluoride varnish was applied every control visit every three months during 1 year.

Treatment:

Other: fluoride varnish

Other: resin infiltration

fluoride varnish

Active Comparator group

Description:

The control group (40 children) had all tooth surfaces including WSL treated with fluoride varnish (Duraphat Colgate Palmolive, Hamburg, Germany)only at baseline evaluation and every control visit every three months during 1 year.

Treatment:

Other: fluoride varnish