Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study - Full Text View

Sponsored by:	University of Pernambuco
Information provided by:	University of Pernambuco
ClinicalTrials.gov Identifier:	NCT00723515

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 IV

Drug Information available for: Calcium gluconate Fluoride Sodium fluoride Stannous fluoride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study

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
G1: Active Comparator NaF (sodium fluoride varnish) with 2.26% of fluoride	Drug: sodium fluoride sodium fluoride 5%
G2: Experimental NaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride)	Drug: sodium fluoride calcium fluoride sodium fluoride 5% + calcium fluoride

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, Pernambuco
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

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

Keywords provided by University of Pernambuco:

White spot lesion
Tooth remineralization
Fluoride varnishes

Study placed in the following topic categories:

Fluorides, Topical
Calcium, Dietary
Tooth Diseases

Stomatognathic Diseases
Fluorides
Dental Caries

Additional relevant MeSH terms:

Cariostatic Agents
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions
Tooth Demineralization

ClinicalTrials.gov processed this record on January 16, 2009