Randomized Trial on Resin Infiltration in Deciduous Teeth

Not Applicable

Completed

• Conditions: White Spot Lesions; Caries
• Interventions: Other: resin infiltration; Other: fluoride varnish

• Registration Number: NCT01881100
• Lead Sponsor: Medical University of Warsaw

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2012-05
• Study Completion: 2012-08
• Status Verified: 2013-06
• Study First Submitted: 2013-06-16
• Study First Submitted QC: 2013-06-16
• Last Update Submitted: 2013-06-16
• Study First Posted: 2013-06-19
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resin infiltration	resin infiltration	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.
resin infiltration	fluoride varnish	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.
fluoride varnish	fluoride varnish	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.

Primary Outcome Measures

Name	Time	Method
Resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth versus fluoride varnish therapy only.	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).

Trial Locations

Locations (1)

Dorota Olczak-Kowalczyk; 🇵🇱 Warsaw, Warsaw, 18 Miodowa St, Poland