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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: sodium fluoride
* Drug: sodium fluoride calcium fluoride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: G1<br>NaF (sodium fluoride varnish) with 2.26% of fluoride | Drug: sodium fluoride<br>* sodium fluoride 5%<br>* Other names: Duraphat®, Colgate Palmolive GmbH, Hamburg, Germany;|
| Experimental: G2<br>NaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride) | Drug: sodium fluoride calcium fluoride<br>* sodium fluoride 5% + calcium fluoride<br>* Other names: Duofluorid XII®, FGM, Joinville, Brazil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of the size of the caries lesion |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inactivation of carious lesions |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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White spot lesion, Tooth remineralization, Fluoride varnishes