Fluoride Varnish for Treatment of White Spot Lesions

Not Applicable

Completed

• Conditions: White Spot Lesions
• Interventions: Device: Vanish Varnish; Device: Pediagel

• Registration Number: NCT01500187
• Lead Sponsor: Solventum US LLC

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2011-12-27
• Study First Posted: 2011-12-28
• Study Start: 2012-02
• Primary Completion: 2014-03-31
• Study Completion: 2014-03-31
• Results First Submitted: 2019-02-01
• Results First Submitted QC: 2019-02-01
• Results First Posted: 2019-02-26
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3M Vanish Varnish	Vanish Varnish	5% sodium fluoride varnish
Pediagel	Pediagel	1.23% Acidulated Phosphate Fluoride Gel

Primary Outcome Measures

Name	Time	Method
DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison	Baseline, Three and Six Month	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.

Trial Locations

Locations (1)

College of Dentistry; 🇺🇸 Memphis, Tennessee, United States