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

Not Applicable

Active, not recruiting

• Conditions: White Spot Lesion
• Interventions: Other: Fluoride varnsh; Other: Normal saline

• Registration Number: NCT06403371
• Lead Sponsor: King Abdullah University Hospital

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.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2024-04-16
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-03
• Last Update Submitted: 2024-05-03
• Study First Posted: 2024-05-07
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-06
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoride varnish group	Fluoride varnsh	Patients received a layer of fluoride varnish on their teeth before the start of orthodontic clear aligner therapy
Control group	Normal saline	Patients received a layer of normal saline on their teeth before the start of orthodontic clear aligner therapy

Primary Outcome Measures

Name	Time	Method
Average lesion fluorescence loss (∆F%)	4 months	It reflects amount of mineral loss
Lesion area	4 months	It measures white spot lesion area in pixels
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

Secondary Outcome Measures

Name	Time	Method
Plaque measurement	4 months	It measures the amount of plaque on teeth surfaces in percent using QLF system

Trial Locations

Locations (1)

Postgraduate Teaching Clinics/JUST; 🇯🇴 Irbid, Jordan