NCT06403371

The Effect of Fluoride Varnish on White Spot Lesion in Clear Aligner Orthodontic Patients

The Effect of Fluoride Varnish on White Spot Lesion in Clear Aligner Orthodontic Patients: Prospective Randomized Controlled Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: King Abdullah University Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• White Spot Lesion

Interventions

Type	Name	Description
OTHER	Fluoride varnsh	Fluoride varnish was applied to the teeth surfaces before aligner therapy
OTHER	Normal saline	Normal saline was applied to the teeth surfaces before aligner therapy

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-06-01
• Completion: 2024-10-01
• First posted: 2024-05-07
• Last updated: 2024-05-07

Locations

1 site across 1 country: Jordan