Clinical trial NCT06403371: The Effect of Fluoride Varnish on White Spot Lesion in Clear Aligner Orthodontic Patients
Official title: The Effect of Fluoride Varnish on White Spot Lesion in Clear Aligner Orthodontic Patients: Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: White Spot Lesion
Keywords: Fluoride varnish
Clear aligners
White spot lesions
Quantitative light induced fluorescence (QLF)
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2024-05-07
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded randomized controlled clinical trial
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Average lesion fluorescence loss (∆F%)
timeFrame: 4 months
measure: Maximum lesion fluorescence loss (∆F-max%)
timeFrame: 4 months
measure: Lesion area
timeFrame: 4 months
Secondary outcomes:
measure: Plaque measurement
timeFrame: 4 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Postgraduate Teaching Clinics/JUST
Study officials:
affiliation: Jordan University of Science and Technology
name: Susan Al-Khateeb
role: PRINCIPAL_INVESTIGATOR
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