Randomized Trial on Resin Infiltration in Deciduous Teeth

NCT ID: NCT01881100

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-08-31

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.

Conditions

White Spot Lesions; Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

resin infiltration

Intervention Type: OTHER

The test group (41 children) had caries lesions treated with the resin infiltration technique using Icon by the following procedure: rubber dam applying; etching with 15% hydrochloric acid for 120 s; surface rinsing and drying; dehydrating with ethanol for 30 s and air-drying; infiltrant resin infiltration with a syringe for 180 s; resin polymerization (polymerized by blue light - wavelength of 450 nm and intensity of 800mW/cm2; resin reapplication for 60 s and polymerization; rubber dam removal, and working on the infiltrated lesion with polishing rubbers. After the procedure fluoride varnish was applied.

fluoride varnish

Intervention Type: OTHER

All tooth surfaces including WSL treated with fluoride varnish (2,26% F, Duraphat ® Colgate Palmolive, Hamburg, Germany).

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.

Group Type: ACTIVE_COMPARATOR

fluoride varnish

Intervention Type: OTHER

All tooth surfaces including WSL treated with fluoride varnish (2,26% F, Duraphat ® Colgate Palmolive, Hamburg, Germany).

Interventions

resin infiltration

The test group (41 children) had caries lesions treated with the resin infiltration technique using Icon by the following procedure: rubber dam applying; etching with 15% hydrochloric acid for 120 s; surface rinsing and drying; dehydrating with ethanol for 30 s and air-drying; infiltrant resin infiltration with a syringe for 180 s; resin polymerization (polymerized by blue light - wavelength of 450 nm and intensity of 800mW/cm2; resin reapplication for 60 s and polymerization; rubber dam removal, and working on the infiltrated lesion with polishing rubbers. After the procedure fluoride varnish was applied.

Intervention Type: OTHER

fluoride varnish

All tooth surfaces including WSL treated with fluoride varnish (2,26% F, Duraphat ® Colgate Palmolive, Hamburg, Germany).

Intervention Type: OTHER

Other Intervention Names

Icon DMG Germany; Duraphat Colgate Palmolive Germany; Duraphat Colgate Palmolive, Hamburg, Germany

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 71 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Anna Turska Szybka

Phd,MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dorota Olczak-Kowalczyk, Ass. Prof.

Role: STUDY_DIRECTOR

Warsaw Medical University, 61 Żwirki i Wigury St.,02-091Warsaw

Dorota Olczak-Kowalczyk, Ass.Prof.

Role: STUDY_DIRECTOR

Warsaw Medical University, Poland

Locations

Dorota Olczak-Kowalczyk

Warsaw, Warsaw, 18 Miodowa Saint, Poland

Countries

Poland

Other Identifiers

WarsawMU

Identifier Type: OTHER

Identifier Source: secondary_id

No sponsor ID

Identifier Type: -

Identifier Source: org_study_id