A Phase 4 interventional study of sodium fluoride and sodium fluoride calcium fluoride in Dental Caries, sponsored by University of Pernambuco. Completed at 1 site in Brazil. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2008-07-28.
Sponsored by University of Pernambuco · Phase 4, Interventional, and Treatment
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.
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.
1,137 studies on the registry are indexed under Dental Caries; 201 are open to participants now.
This study's enrollment of 45 is below the median of 60 across 936 interventional studies indexed under Dental Caries.
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Exclusion Criteria:
NaF (sodium fluoride varnish) with 2.26% of fluoride
Drug: sodium fluoride
NaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride)
Drug: sodium fluoride calcium fluoride
sodium fluoride 5%
Also known as: Duraphat®, Colgate Palmolive GmbH, Hamburg, Germany
sodium fluoride 5% + calcium fluoride
Also known as: Duofluorid XII®, FGM, Joinville, Brazil
reduction of the size of the caries lesion
Time frame: 4 weeks
Inactivation of carious lesions
Time frame: 4 weeks
This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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University of Pernambuco