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

May 3, 2024 updated by: Suzan Al-Khateeb, King Abdullah University Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • Postgraduate Teaching Clinics/JUST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluoride varnish group
Patients received a layer of fluoride varnish on their teeth before the start of orthodontic clear aligner therapy
Other: Fluoride varnsh
Fluoride varnish was applied to the teeth surfaces before aligner therapy
Placebo Comparator: Control group
Patients received a layer of normal saline on their teeth before the start of orthodontic clear aligner therapy
Other: Normal saline
Normal saline was applied to the teeth surfaces before aligner therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average lesion fluorescence loss (∆F%)
Time Frame: 4 months
It reflects amount of mineral loss
4 months
Maximum lesion fluorescence loss (∆F-max%)
Time Frame: 4 months
It measures the deepest point of the lesion (in relation to sound enamel) using QLF system in percent
4 months
Lesion area
Time Frame: 4 months
It measures white spot lesion area in pixels
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque measurement
Time Frame: 4 months
It measures the amount of plaque on teeth surfaces in percent using QLF system
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah University Hospital

Collaborators

Jordan University of Science and Technology

Investigators

  • Principal Investigator: Susan Al-Khateeb, Jordan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JUST20230273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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