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Fluoride Varnish for Treatment of White Spot Lesions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01500187
First Posted: December 28, 2011
Last Update Posted: January 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Tennessee Health Science Center
Information provided by (Responsible Party):
3M
  Purpose
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 Intervention
White Spot Lesions Device: Vanish varnish Device: Oral B Minute-Gel

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by 3M:

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


Estimated Enrollment: 30
Study Start Date: February 2012
Study Completion Date: December 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Criteria

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


Locations
United States, Tennessee
College of Dentistry
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
3M
University of Tennessee Health Science Center
Investigators
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 Submitted: December 22, 2011
First Posted: December 28, 2011
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
Fluorides
Sodium Fluoride
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs