Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study
- Conditions
- Dental Caries
- Interventions
- Drug: sodium fluoride calcium fluoride
- Registration Number
- NCT00723515
- Lead Sponsor
- University of Pernambuco
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- regular hygiene habits (brushing teeth everyday)
- registered in public schools
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G1 sodium fluoride NaF (sodium fluoride varnish) with 2.26% of fluoride G2 sodium fluoride calcium fluoride NaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride)
- Primary Outcome Measures
Name Time Method reduction of the size of the caries lesion 4 weeks
- Secondary Outcome Measures
Name Time Method Inactivation of carious lesions 4 weeks
Trial Locations
- Locations (1)
University of Pernambuco
🇧🇷Camaragibe, Pernambuco, Brazil