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

White Spot Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06403371
• Other study ID #: JUST20230273
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: King Abdullah University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: October 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exanthema
• White Spot Lesion

Intervention

Other:
• Fluoride varnsh
Fluoride varnish was applied to the teeth surfaces before aligner therapy
• Normal saline
Normal saline was applied to the teeth surfaces before aligner therapy

Locations

Country	Name	City	State
Jordan	Postgraduate Teaching Clinics/JUST	Irbid

Sponsors (2)

Lead Sponsor	Collaborator
King Abdullah University Hospital	Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average lesion fluorescence loss (?F%)	It reflects amount of mineral loss	4 months
Primary	Maximum lesion fluorescence loss (?F-max%)	It measures the deepest point of the lesion (in relation to sound enamel) using QLF system in percent	4 months
Primary	Lesion area	It measures white spot lesion area in pixels	4 months
Secondary	Plaque measurement	It measures the amount of plaque on teeth surfaces in percent using QLF system	4 months