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

Not Applicable

Completed

• Conditions: White Spot Lesion
• Interventions: Device: Pro Seal Sealant; Device: MI Varnish

• Registration Number: NCT04560478
• Lead Sponsor: Texas A&M University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2020-02-10
• Study Completion: 2020-03-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Last Update Submitted: 2020-09-17
• Study First Posted: 2020-09-23
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pro Seal Sealant	Pro Seal Sealant	ProSeal Sealant was applied to the facial surfaces of the maxillary anterior teeth (canine to canine)
MI Varnish	MI Varnish	MI Fluoride Varnish was applied to the maxillary anterior teeth (canine to canine)

Primary Outcome Measures

Name	Time	Method
Enamel Decalcification Index	12 months	Extent and severity of white spot lesion formation

Secondary Outcome Measures

Name	Time	Method
Location of White Spot Lesions	12 months	Mesial, Distal, Incisal or Gingival Region
Most Common Tooth for White Spot Formation	12 Months	Maxillary Canine, Lateral, or Central Incisor
Oral Hygiene Status	12 Months	Measurement of plaque accumulation on maxillary teeth
Sex Differences	12 Months	Male versus Female

Trial Locations

Locations (1)

Texas A&M University College of Dentistry; 🇺🇸 Dallas, Texas, United States