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

July 24, 2008 updated by: University of Pernambuco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Camaragibe, Pernambuco, Brazil, 54753-220
        • University of Pernambuco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: G1
NaF (sodium fluoride varnish) with 2.26% of fluoride
Drug: sodium fluoride
sodium fluoride 5%
Other Names:
  • Duraphat®, Colgate Palmolive GmbH, Hamburg, Germany
EXPERIMENTAL: G2
NaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride)
Drug: sodium fluoride calcium fluoride
sodium fluoride 5% + calcium fluoride
Other Names:
  • Duofluorid XII®, FGM, Joinville, Brazil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reduction of the size of the caries lesion
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Inactivation of carious lesions
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pernambuco

Investigators

  • Principal Investigator: Jainara MS Ferreira, Master, University of Pernambuco
  • Study Chair: Ana Karla R Aragão, Graduate, Univeristy of Pernambuco
  • Study Chair: Adriana DB Rosa, student, Federal University of Paraiba
  • Study Chair: Fabio C Sampaio, PhD, Federal Univerisity of Paraiba
  • Study Chair: Valdenice A Menezes, PhD, Univeristy of Pernambuco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

July 24, 2008

First Submitted That Met QC Criteria

July 24, 2008

First Posted (ESTIMATE)

July 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 28, 2008

Last Update Submitted That Met QC Criteria

July 24, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPE 260/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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