Fluoride Varnish for Treatment of White Spot Lesions

NCT ID: NCT01500187

Last Updated: 2024-10-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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White Spot Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pediagel

1.23% Acidulated Phosphate Fluoride Gel

Group Type ACTIVE_COMPARATOR

Pediagel

Intervention Type DEVICE

1.23% Acidulated Phosphate Fluoride Gel

3M Vanish Varnish

5% sodium fluoride varnish

Group Type EXPERIMENTAL

Vanish Varnish

Intervention Type DEVICE

5% sodium fluoride varnish with tricalcium phosphate

Interventions

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Vanish Varnish

5% sodium fluoride varnish with tricalcium phosphate

Intervention Type DEVICE

Pediagel

1.23% Acidulated Phosphate Fluoride Gel

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tennessee

OTHER

Sponsor Role collaborator

3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franklin Garcia-Godoy, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

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College of Dentistry

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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ORTHO2011-01

Identifier Type: OTHER

Identifier Source: secondary_id

CR-11-011

Identifier Type: -

Identifier Source: org_study_id

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