N/A
N=38
Fluoride Varnish for Treatment of White Spot Lesions
White Spot Lesions
Bottom Line
View on ClinicalTrials.gov: NCT01500187 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison — 5.10; 6.01; 4.08; 5.50 units on a scale — p=0.636
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vanish Varnish (Device); Pediagel (Device)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Solventum US LLC
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison |
5.10; 6.01; 4.08; 5.50; 3.52; 3.95 | 0.636 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01500187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.