Fluoride Varnish for Treatment of White Spot Lesions

Solventum US LLC

Status: Completed

Conditions: White Spot Lesions

Treatments: Device: Vanish Varnish; Device: Pediagel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01500187

CR-11-011

ORTHO2011-01 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 12 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Pediagel

Active Comparator group

Description:

1.23% Acidulated Phosphate Fluoride Gel

Treatment:

Device: Pediagel

3M Vanish Varnish

Experimental group

Description:

5% sodium fluoride varnish

Treatment:

Device: Vanish Varnish