Randomized Trial on Resin Infiltration in Deciduous Teeth

Not Applicable

Completed

• Conditions: White Spot Lesions; Caries

• 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

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