Comparing Fluoride Varnish and Sealant to Prevent White Spots in Orthodontic Patients

Texas A&M University

Status: Completed

Conditions: White Spot Lesion

Treatments: Device: MI Varnish; Device: Pro Seal Sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT04560478

COD_Ortho2

Details and patient eligibility

About

The purpose of the study is o compare the efficacy of CPP-ACP MI Varnish and ProSeal sealant in preventing white spot lesion (WSL) formation in orthodontic patients.

Full description

This prospective randomized clinical trial included 40 orthodontic patients between the ages of 12-17 who were randomly allocated to two groups. Group 1 (Sealant Group) received sealant on the maxillary anterior canines, lateral incisors, and central incisors, with reapplication of the sealant every 3 months. Group 2 (Varnish Group) had MI Varnish applied every 4-6 weeks, without sealant placed on the maxillary anterior teeth. White spot lesion formation was evaluated with standardized digital photographs at two timepoints, T1 (initial appointment before bonding), and T2 (12 months later, with brackets removed). The brackets were removed in order to facilitate an adequate photographic exam. Photographs were analyzed side-by-side at the conclusion of the study with the Enamel Decalcification Index (EDI). The location of WSLs were recorded by tooth type and by region. Oral hygiene was evaluated at T1 and T2.

Enrollment: 40 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• no significant medical history
• no underlying medical problems such as Sjogren's Syndrome or conditions requiring more than 2 medications (to prevent bias of possible dry mouth)
• less than 17 years old at the start of orthodontic treatment,
• fully erupted permanent maxillary canines and incisors, starting fixed orthodontic treatment
• ability to come to appointments every 4-6 weeks.

Exclusion criteria

• professional fluoride application in the last 3 months
• allergy to milk
• untreated cavitated lesions
• heavy initial fluorosis
• dry mouth
• pregnancy
• any illness/condition that the investigators felt would affect the study outcome.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Pro Seal Sealant

Active Comparator group

Description:

ProSeal Sealant was applied to the facial surfaces of the maxillary anterior teeth (canine to canine)

Treatment:

Device: Pro Seal Sealant

MI Varnish

Active Comparator group

Description:

MI Fluoride Varnish was applied to the maxillary anterior teeth (canine to canine)

Treatment:

Device: MI Varnish