Fluoride Varnish for Treatment of White Spot Lesions
Fluoride Varnish Application for Treatment of White Spot Lesion After Fixed Orthodontic Treatment. A Pilot Study.
2 other identifiers
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2011
CompletedFirst Posted
Study publicly available on registry
December 28, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2014
CompletedResults Posted
Study results publicly available
February 26, 2019
CompletedOctober 2, 2024
September 1, 2024
2.2 years
December 22, 2011
February 1, 2019
September 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Three and Six Month
Study Arms (2)
Pediagel
ACTIVE COMPARATOR1.23% Acidulated Phosphate Fluoride Gel
3M Vanish Varnish
EXPERIMENTAL5% sodium fluoride varnish
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solventum US LLClead
- University of Tennesseecollaborator
- 3Mcollaborator
Study Sites (1)
College of Dentistry
Memphis, Tennessee, 38163, United States
Results Point of Contact
- Title
- Franklin Garcia-Godoy DDDS, MS PhD
- Organization
- University of Health Science Center
Study Officials
- PRINCIPAL INVESTIGATOR
Franklin Garcia-Godoy, DDS, MS
University of Tennessee
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2011
First Posted
December 28, 2011
Study Start
February 1, 2012
Primary Completion
March 31, 2014
Study Completion
March 31, 2014
Last Updated
October 2, 2024
Results First Posted
February 26, 2019
Record last verified: 2024-09