Clinical trial NCT00723515: Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study
Official title: Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Keywords: White spot lesion
Tooth remineralization
Fluoride varnishes
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
First posted: 2008-07-28
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: reduction of the size of the caries lesion
timeFrame: 4 weeks
Secondary outcomes:
measure: Inactivation of carious lesions
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Camaragibe
country: Brazil
facility: University of Pernambuco
state: Pernambuco
Study officials:
affiliation: University of Pernambuco
name: Jainara MS Ferreira, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Univeristy of Pernambuco
name: Ana Karla R Aragão, Graduate
role: STUDY_CHAIR
affiliation: Federal University of Paraiba
name: Adriana DB Rosa, student
role: STUDY_CHAIR
affiliation: Federal Univerisity of Paraiba
name: Fabio C Sampaio, PhD
role: STUDY_CHAIR
affiliation: Univeristy of Pernambuco
name: Valdenice A Menezes, PhD
role: STUDY_CHAIR
References:
citation: Ferreira JM, Aragao AK, Rosa AD, Sampaio FC, Menezes VA. Therapeutic effect of two fluoride varnishes on white spot lesions: a randomized clinical trial. Braz Oral Res. 2009 Oct-Dec;23(4):446-51. doi: 10.1590/s1806-83242009000400015.