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Fluoride Varnish for Treatment of White Spot Lesions

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ClinicalTrials.gov Identifier: NCT01500187
Recruitment Status : Completed
First Posted : December 28, 2011
Last Update Posted : January 19, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
White Spot Lesions Device: Vanish varnish Device: Oral B Minute-Gel

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fluoride Varnish Application for Treatment of White Spot Lesion After Fixed Orthodontic Treatment. A Pilot Study.
Study Start Date : February 2012
Primary Completion Date : October 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Group 2
Oral B Minute-Gel, fluoride gel
Device: Oral B Minute-Gel
Fluoride gel
Experimental: Group 1
Vanish varnish, 5% sodium fluoride varnish with tricalcium phosphate
Device: Vanish varnish
5% sodium fluoride varnish with tricalcium phosphate
Other Name: Vanish White Varnish

Outcome Measures

Primary Outcome Measures :
  1. Remineralization of enamel white spot lesion [ Time Frame: 6 months ]
    Outcome of fluoride varnish or gel application to white spot lesions after orthodontic debonding.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500187

United States, Tennessee
College of Dentistry
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
University of Tennessee Health Science Center
Principal Investigator: Franklin Garcia-Godoy, DDS, MS University of Tennessee Health Science Center
More Information

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01500187     History of Changes
Other Study ID Numbers: CR-11-011
ORTHO2011-01 ( Other Identifier: University of Tennessee )
First Posted: December 28, 2011    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: December 2013

Keywords provided by 3M:
white spot lesions
fixed orthodontic brackets
fluoride varnish
fluoride gel

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Sodium Fluoride
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs