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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00723515
Enrollment
45
Registered
2008-07-28
Start date
2007-02-28
Completion date
2007-10-31
Last updated
2008-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

White spot lesion, Tooth remineralization, Fluoride varnishes

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.

Interventions

sodium fluoride 5%

DRUGsodium fluoride calcium fluoride

sodium fluoride 5% + calcium fluoride

Sponsors

University of Pernambuco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
reduction of the size of the caries lesion4 weeks

Secondary

MeasureTime frame
Inactivation of carious lesions4 weeks

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026