White Spot Lesion
Conditions
Keywords
Fluoride varnish, Clear aligners, White spot lesions, Quantitative light induced fluorescence (QLF)
Brief summary
Fluoride varnish is being applied on the teeth surfaces of patients undergoing orthodontic treatment just before receiving their clear aligners. The effect of the varnish was investigated if it can reduce the incidence of enamel demineralization or not.
Detailed description
Background: The preventive effect of fluoride varnish on the development of white spot lesions (WSLs) during clear aligner treatment has not been investigated in the literature. Hence this was the purpose of this study. Material and Methods: This was a prospective double-blinded randomized clinical trial. A total of 44 patients (7 males, 37 females, with a mean age of 20.91 ± 4.56) who sought clear aligner therapy at the postgraduate orthodontic clinics at JUST were recruited and randomly divided equally (n=22 in each group) by a website randomizer. Eligibility criteria included healthy patients of both sexes (age range 14-30 years), Class I malocclusion with mild-to-moderate crowding (≤5 mm), non-extraction treatment plan, and optimum oral hygiene before treatment. Both the patient and the investigator were blinded during the intervention and assessment of outcomes. At (T0) Fluoride varnish was applied to the subjects in Group 1, while normal saline was applied to the subjects in Group 2 as a control. Quantitative light-induced fluorescence (QLF) images were taken at the start of the treatment (T0) and after 4 months (T1). The QLF images were analyzed to assess the primary outcomes: lesion area (Pixels), the mean amount of fluorescence loss (ΔF)% in addition to the number of newly developed lesions.
Interventions
OTHERFluoride varnsh
Fluoride varnish was applied to the teeth surfaces before aligner therapy
OTHERNormal saline
Normal saline was applied to the teeth surfaces before aligner therapy
Sponsors
Jordan University of Science and Technology
King Abdullah University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Nor the subjects neither the investigator knew the type of varnish they received. Additionally, the outcome assessor was blinded before making the analysis
Intervention model description
Double blinded randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects form both sexes * Mild to moderate crowding * Optimum oral hygiene * Maximum of three restored teeth
Exclusion criteria
* Presence of enamel hypoplasia or hypocalcification, * Any salivary gland disease or medication use that affect the salivary flow * Subjects using fluoride other than 1450 ppm fluoride toothpaste.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average lesion fluorescence loss (∆F%) | 4 months | It reflects amount of mineral loss |
| Maximum lesion fluorescence loss (∆F-max%) | 4 months | It measures the deepest point of the lesion (in relation to sound enamel) using QLF system in percent |
| Lesion area | 4 months | It measures white spot lesion area in pixels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque measurement | 4 months | It measures the amount of plaque on teeth surfaces in percent using QLF system |
Countries
Jordan
Outcome results
None listed