Fluoride Varnish for Treatment of White Spot Lesions

White Spot Lesions Clinical Trial

Official title:

Fluoride Varnish Application for Treatment of White Spot Lesion After Fixed Orthodontic Treatment. A Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500187
• Other study ID #: CR-11-011
• Secondary ID: ORTHO2011-01
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: March 31, 2014

Study information

• Verified date: May 2019
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 31, 2014
• Est. primary completion date: March 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesions

Intervention

Device:
• Vanish Varnish
5% sodium fluoride varnish with tricalcium phosphate
• Pediagel
1.23% Acidulated Phosphate Fluoride Gel

Locations

Country	Name	City	State
United States	College of Dentistry	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
3M	University of Tennessee Health Science Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Three and Six Month