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

NCT06403371 | Active Not Recruiting

• 1 other identifier: JUST20230273
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

White Spot Lesion

Keywords

Fluoride varnish; Clear aligners; White spot lesions; Quantitative light induced fluorescence (QLF)

Outcome Measures

Primary Outcomes (3)

• Average lesion fluorescence loss (∆F%)

  It reflects amount of mineral loss

  4 months

• 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

• Lesion area

  It measures white spot lesion area in pixels

  4 months

Secondary Outcomes (1)

• Plaque measurement

  4 months

Study Arms (2)

Fluoride varnish group

EXPERIMENTAL

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

Other: Fluoride varnsh

Control group

PLACEBO COMPARATOR

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

Other: Normal saline

Interventions

Fluoride varnsh OTHER

Fluoride varnish was applied to the teeth surfaces before aligner therapy

Fluoride varnish group

Normal saline OTHER

Normal saline was applied to the teeth surfaces before aligner therapy

Control group

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy subjects form both sexes
• Mild to moderate crowding
• Optimum oral hygiene
• Maximum of three restored teeth

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Postgraduate Teaching Clinics/JUST

Irbid, 22110, Jordan

Location

Related Publications (39)

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MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Susan Al-Khateeb

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Nor the subjects neither the investigator knew the type of varnish they received. Additionally, the outcome assessor was blinded before making the analysis
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Orthodontics

Model Details: Double blinded randomized controlled clinical trial

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 7, 2024
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)