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

NCT ID: NCT00723515

Last Updated: 2008-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Dental Caries

Keywords

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White spot lesion Tooth remineralization Fluoride varnishes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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G1

NaF (sodium fluoride varnish) with 2.26% of fluoride

Group Type ACTIVE_COMPARATOR

sodium fluoride

Intervention Type DRUG

sodium fluoride 5%

G2

NaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride)

Group Type EXPERIMENTAL

sodium fluoride calcium fluoride

Intervention Type DRUG

sodium fluoride 5% + calcium fluoride

Interventions

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sodium fluoride

sodium fluoride 5%

Intervention Type DRUG

sodium fluoride calcium fluoride

sodium fluoride 5% + calcium fluoride

Intervention Type DRUG

Other Intervention Names

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Duraphat®, Colgate Palmolive GmbH, Hamburg, Germany Duofluorid XII®, FGM, Joinville, Brazil

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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University of Pernambuco

Principal Investigators

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Jainara MS Ferreira, Master

Role: PRINCIPAL_INVESTIGATOR

University of Pernambuco

Ana Karla R Aragão, Graduate

Role: STUDY_CHAIR

Univeristy of Pernambuco

Adriana DB Rosa, student

Role: STUDY_CHAIR

Federal University of Paraiba

Fabio C Sampaio, PhD

Role: STUDY_CHAIR

Federal Univerisity of Paraiba

Valdenice A Menezes, PhD

Role: STUDY_CHAIR

Univeristy of Pernambuco

Locations

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University of Pernambuco

Camaragibe, Pernambuco, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 20027453 (View on PubMed)

Other Identifiers

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UPE 260/08

Identifier Type: -

Identifier Source: org_study_id