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Fluoride Varnish for Treatment of White Spot Lesions

Primary Purpose

White Spot Lesions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vanish Varnish
Pediagel
Sponsored by
3M
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for White Spot Lesions focused on measuring white spot lesions, fixed orthodontic brackets, fluoride varnish, fluoride gel

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • College of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pediagel

3M Vanish Varnish

Arm Description

1.23% Acidulated Phosphate Fluoride Gel

5% sodium fluoride varnish

Outcomes

Primary Outcome Measures

DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison
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.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2011
Last Updated
May 13, 2019
Sponsor
3M
Collaborators
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT01500187
Brief Title
Fluoride Varnish for Treatment of White Spot Lesions
Official Title
Fluoride Varnish Application for Treatment of White Spot Lesion After Fixed Orthodontic Treatment. A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 31, 2014 (Actual)
Study Completion Date
March 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
Collaborators
University of Tennessee

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
White Spot Lesions
Keywords
white spot lesions, fixed orthodontic brackets, fluoride varnish, fluoride gel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pediagel
Arm Type
Active Comparator
Arm Description
1.23% Acidulated Phosphate Fluoride Gel
Arm Title
3M Vanish Varnish
Arm Type
Experimental
Arm Description
5% sodium fluoride varnish
Intervention Type
Device
Intervention Name(s)
Vanish Varnish
Intervention Description
5% sodium fluoride varnish with tricalcium phosphate
Intervention Type
Device
Intervention Name(s)
Pediagel
Intervention Description
1.23% Acidulated Phosphate Fluoride Gel
Primary Outcome Measure Information:
Title
DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison
Description
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.
Time Frame
Baseline, Three and Six Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franklin Garcia-Godoy, DDS, MS
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Dentistry
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

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Fluoride Varnish for Treatment of White Spot Lesions

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