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NCT Number: NCT00723515

Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study

The study hypothesis is the difference in therapeutic effect of two varnish formulations (G1 = NaF, 2.26%F, G2 = NaF, 2.71% F + CaF2). These products are commercially available in the Brazilian and international market and they are used for dental caries as white spot lesions control.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pernambuco

Camaragibe, Pernambuco, 54753-220, Brazil

About this study

The aim of this study was to evaluate the therapeutic effect of two varnish formulations (G1 = NaF, 2.26%F, G2 = NaF, 2.71% F + CaF2) on the remineralization of white spot lesions (WSL). The sample was composed of 15 (7- to 12-year-old) children with 45 active WSL in anterior permanent teeth. The children were randomly divided in two groups providing 22 lesions for G1 and 23 for G2. The children were submitted to weekly varnish applications 4 times. The WSL were evaluated twice: baseline and on week 4. Maximum lesion dimensions (mesial-distal and incisal-gingival) were measured in millimeters and classified in four grades of size. WSL were also recorded assessing lesion activity by one calibrated examiner. The Pearson chi-square and Fisher's exact tests were used (P < 0.01). WSL reductions were observed in both varnish groups (Chi-square= 0.15, d.f.=1, P=0.90); and with similar magnitude (in mm): 1.19 and 1.29 for G1 and G2, respectively. Thirty-six WLS (15 in G1 and 26 in G2) were classified as inactive in week 4 reaching an overall value of 80%. No difference was observed between G1 and G2 regarding activity scores (Fisher's exact test, p > 0.01). It can be concluded that after 4 applications the two varnish formulations tested produced similar clinical effects indicating the reduction and the control of carious activity in most WSL.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • regular hygiene habits (brushing teeth everyday)
  • registered in public schools

Exclusion criteria

  • dental caries such as small cavities or restorations in the target teeth (permanent anterior teeth)
  • development enamel alterations (hypoplasia, fluorosis) or periodontal disease
  • children using orthodontic devices
  • under medical treatment
  • taking any kind of medicine
  • no informed consent form signed

Treatment and study plan

Sodium Fluoride

Drug

sodium fluoride 5%

Other names: Duraphat®, Colgate Palmolive GmbH, Hamburg, Germany

sodium fluoride calcium fluoride

Drug

sodium fluoride 5% + calcium fluoride

Other names: Duofluorid XII®, FGM, Joinville, Brazil

Primary outcomes

  1. reduction of the size of the caries lesion

    Time frame: 4 weeks

Secondary outcomes

  1. Inactivation of carious lesions

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Pernambuco

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 28, 2008
Registry last updated
Jul 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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