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Fluoride Varnish for Treatment of White Spot Lesions

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Tennessee Health Science Center
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01500187
First received: December 22, 2011
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  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: 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:

MedlinePlus related topics: Rashes
U.S. FDA Resources

Further study details as provided by 3M:

Primary Outcome Measures:
  • Remineralization of enamel white spot lesion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Outcome of fluoride varnish or gel application to white spot lesions after orthodontic debonding.


Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: June 2013 (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

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01500187     History of Changes
Other Study ID Numbers: CR-11-011, ORTHO2011-01
Study First Received: December 22, 2011
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Exanthema
Dental Caries
Skin Diseases
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
 Fluorides, Topical
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013