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Sponsored by: |
University of Pernambuco |
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Information provided by: | University of Pernambuco |
ClinicalTrials.gov Identifier: | NCT00723515 |
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.
Condition | Intervention | Phase |
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Dental Caries |
Drug: sodium fluoride Drug: sodium fluoride calcium fluoride |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study |
Enrollment: | 45 |
Study Start Date: | February 2007 |
Study Completion Date: | October 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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G1: Active Comparator
NaF (sodium fluoride varnish) with 2.26% of fluoride
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Drug: sodium fluoride
sodium fluoride 5%
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G2: Experimental
NaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride)
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Drug: sodium fluoride calcium fluoride
sodium fluoride 5% + calcium fluoride
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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.
Ages Eligible for Study: | 7 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil, Pernambuco | |
University of Pernambuco | |
Camaragibe, Pernambuco, Brazil, 54753-220 |
Principal Investigator: | Jainara MS Ferreira, Master | University of Pernambuco |
Study Chair: | Ana Karla R Aragão, Graduate | Univeristy of Pernambuco |
Study Chair: | Adriana DB Rosa, student | Federal University of Paraiba |
Study Chair: | Fabio C Sampaio, PhD | Federal Univerisity of Paraiba |
Study Chair: | Valdenice A Menezes, PhD | Univeristy of Pernambuco |
Responsible Party: | University of Pernambuco ( Jainara Maria Soares Ferreira ) |
Study ID Numbers: | UPE 260/08 |
Study First Received: | July 24, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00723515 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
White spot lesion Tooth remineralization Fluoride varnishes |
Fluorides, Topical Calcium, Dietary Tooth Diseases |
Stomatognathic Diseases Fluorides Dental Caries |
Fluorides, Topical Tooth Diseases Cariostatic Agents Physiological Effects of Drugs Stomatognathic Diseases |
Fluorides Protective Agents Pharmacologic Actions Tooth Demineralization Dental Caries |