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

This study has been completed.
Sponsor:
Information provided by:
University of Pernambuco
ClinicalTrials.gov Identifier:
NCT00723515
First received: July 24, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Dental Caries
 Drug: sodium fluoride
Drug: sodium fluoride calcium fluoride
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pernambuco:

Primary Outcome Measures:
  • reduction of the size of the caries lesion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inactivation of carious lesions [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2007
Study Completion Date: October 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: G1
NaF (sodium fluoride varnish) with 2.26% of fluoride
 Drug: sodium fluoride
sodium fluoride 5%
Other Name: 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 Name: Duofluorid XII®, FGM, Joinville, Brazil

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

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723515

Locations
Brazil
University of Pernambuco
Camaragibe, Pernambuco, Brazil, 54753-220
Sponsors and Collaborators
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
  More Information

No publications provided by University of Pernambuco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jainara Maria Soares Ferreira, University of Pernambuco
ClinicalTrials.gov Identifier: NCT00723515     History of Changes
Other Study ID Numbers: UPE 260/08
Study First Received: July 24, 2008
Last Updated: July 24, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Pernambuco:
White spot lesion
Tooth remineralization
Fluoride varnishes

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides, Topical
Fluorides
 Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013