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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723515
• Other study ID #: UPE 260/08
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2008
• Last updated: July 24, 2008
• Start date: February 2007
• Est. completion date: October 2007

Study information

• Verified date: July 2008
• Source: University of Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• sodium fluoride
sodium fluoride 5%
• sodium fluoride calcium fluoride
sodium fluoride 5% + calcium fluoride

Locations

Country	Name	City	State
Brazil	University of Pernambuco	Camaragibe	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
University of Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of the size of the caries lesion		4 weeks	No
Secondary	Inactivation of carious lesions		4 weeks	No