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

Primary Purpose

Dental Caries

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

sodium fluoride

sodium fluoride calcium fluoride

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring White spot lesion, Tooth remineralization, Fluoride varnishes

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Pernambuco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

NaF (sodium fluoride varnish) with 2.26% of fluoride

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

Outcomes

Primary Outcome Measures

reduction of the size of the caries lesion

Secondary Outcome Measures

Inactivation of carious lesions

Full Information

NCT ID

NCT00723515

First Posted

July 24, 2008

Last Updated

July 24, 2008

Sponsor

University of Pernambuco

1. Study Identification

Unique Protocol Identification Number

NCT00723515

Brief Title

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

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Pernambuco

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

White spot lesion, Tooth remineralization, Fluoride varnishes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

NaF (sodium fluoride varnish) with 2.26% of fluoride

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

sodium fluoride

Other Intervention Name(s)

Duraphat®, Colgate Palmolive GmbH, Hamburg, Germany

Intervention Description

sodium fluoride 5%

Intervention Type

Drug

Intervention Name(s)

sodium fluoride calcium fluoride

Other Intervention Name(s)

Duofluorid XII®, FGM, Joinville, Brazil

Intervention Description

sodium fluoride 5% + calcium fluoride

Primary Outcome Measure Information:

Title

reduction of the size of the caries lesion

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Inactivation of carious lesions

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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

Overall Study Officials: