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

NCT ID: NCT06403371

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-10-31

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.

Conditions

White Spot Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Fluoride varnish group

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

Group Type: EXPERIMENTAL

Fluoride varnsh

Intervention Type: OTHER

Fluoride varnish was applied to the teeth surfaces before aligner therapy

Control group

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: OTHER

Normal saline was applied to the teeth surfaces before aligner therapy

Interventions

Fluoride varnsh

Fluoride varnish was applied to the teeth surfaces before aligner therapy

Intervention Type: OTHER

Normal saline

Normal saline was applied to the teeth surfaces before aligner therapy

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: collaborator

King Abdullah University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Suzan Al-Khateeb

Professor in Orthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Al-Khateeb

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

Postgraduate Teaching Clinics/JUST

Irbid, , Jordan

Countries

Jordan

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Other Identifiers

JUST20230273

Identifier Type: -

Identifier Source: org_study_id