Fluoride Varnish for Treatment of White Spot Lesions

Solventum US LLC38 enrolled

Overview

Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that can occur around the edge of fixed orthodontic brackets.

To determine the efficacy of 5% sodium fluoride varnish with tricalcium phosphate in reverting white spot lesions after fixed orthodontic treatment, compared with a fluoride gel.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

White Spot Lesions

Interventions

Vanish VarnishDEVICE

5% sodium fluoride varnish with tricalcium phosphate

PediagelDEVICE

1.23% Acidulated Phosphate Fluoride Gel

Eligibility

Sex: ALLMin age: 12 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * no systemic disease * has completed fixed orthodontic treatment, brackets debonded * has at least two teeth with whitre spot lesions * has received conventional periodontal therapy after orthodontic tretament Exclusion Criteria: * presence of enamel hypoplasia or dental fluorosis * presence of tetracycline pigmentation * periodontal pocketing of 3mm or greater * taking antibiotics * presence of carious cavities * allergy to fluoride gel / varnish being used in study

Locations (1)

College of Dentistry

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison

Outcome of fluoride varnish or gel application to white spot lesions as measured by DIAGNOdent device after orthodontic debonding. Values shown represent the mean DIAGNOdent reading. The DIAGNOdent scale spans values from 0 to 30+ where larger values indicate higher levels of demineralization.

Time frame: Baseline, Three and Six Month

Data from ClinicalTrials.gov

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