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

U

University of Pernambuco

Status and phase

Completed
Phase 4

Conditions

Dental Caries

Treatments

Drug: sodium fluoride calcium fluoride
Drug: sodium fluoride

Study type

Interventional

Funder types

Other

Identifiers

NCT00723515
UPE 260/08

Details and patient eligibility

About

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.

Full description

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.

Enrollment

45 patients

Sex

All

Ages

7 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

45 participants in 2 patient groups

G1
Active Comparator group
Description:
NaF (sodium fluoride varnish) with 2.26% of fluoride
Treatment:
Drug: sodium fluoride
G2
Experimental group
Description:
NaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride)
Treatment:
Drug: sodium fluoride calcium fluoride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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