Randomized Trial on Resin Infiltration in Deciduous Teeth

Caries Clinical Trial

— infiltration  

Official title:

Randomized Clinical Trial on Resin Infiltration Versus Fluoride Varnish Treatment of Early Smooth-surface Caries Lesions in Deciduous Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881100
• Other study ID #: No sponsor ID
• Secondary ID: WarsawMU
• Status: Completed
• Phase: N/A
• First received: June 16, 2013
• Last updated: June 16, 2013
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: June 2013
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 71 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Caries
• White Spot Lesions

Intervention

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

Locations

Country	Name	City	State
Poland	Dorota Olczak-Kowalczyk	Warsaw	Warsaw, 18 Miodowa St

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth versus fluoride varnish therapy only.	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).	one year	Yes