Fluoride Varnish for Treatment of White Spot Lesions

May 13, 2019 updated by: 3M

Fluoride Varnish Application for Treatment of White Spot Lesion After Fixed Orthodontic Treatment. A Pilot Study.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • College of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pediagel
1.23% Acidulated Phosphate Fluoride Gel
Device: Pediagel
1.23% Acidulated Phosphate Fluoride Gel
Experimental: 3M Vanish Varnish
5% sodium fluoride varnish
Device: Vanish Varnish
5% sodium fluoride varnish with tricalcium phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison
Time Frame: Baseline, Three and Six Month
Outcome of fluoride varnish or gel application to white spot lesions as measured by DIAGNOdent device after orthodontic debonding. Values shown represent the mean DIAGNOdent reading. The DIAGNOdent scale spans values from 0 to 30+ where larger values indicate higher levels of demineralization.
Baseline, Three and Six Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3M

Collaborators

University of Tennessee Health Science Center

Investigators

  • Principal Investigator: Franklin Garcia-Godoy, DDS, MS, University of Tennessee Health Science Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

March 31, 2014

Study Completion (Actual)

March 31, 2014

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

December 27, 2011

First Posted (Estimate)

December 28, 2011

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-11-011
  • ORTHO2011-01 (Other Identifier: University of Tennessee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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