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

King Abdullah University Hospital

Status: Active, not recruiting

Conditions: White Spot Lesion

Treatments: Other: Normal saline; Other: Fluoride varnsh

Study type: Interventional

Funder types: Other

Identifiers

NCT06403371

JUST20230273

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 16 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

Fluoride varnish group

Experimental group

Description:

Patients received a layer of fluoride varnish on their teeth before the start of orthodontic clear aligner therapy

Treatment:

Other: Fluoride varnsh

Control group

Placebo Comparator group

Description:

Patients received a layer of normal saline on their teeth before the start of orthodontic clear aligner therapy

Treatment:

Other: Normal saline