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

THE EFFICACY OF MI VARNISH VERSUS PRO SEAL SEALANT ON PREVENTION OF WHITE SPOT LESIONS IN ORTHODONTIC PATIENTS: A RANDOMIZED CLINICAL TRIAL

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.

Study Overview

• Status: Completed
• Conditions: White Spot Lesion
• Intervention / Treatment: Device: Pro Seal Sealant; Device: MI Varnish

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas A&M University College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Pro Seal Sealant; ProSeal Sealant was applied to the facial surfaces of the maxillary anterior teeth (canine to canine)	Device: Pro Seal Sealant; Sealant was reapplied every 3 months
ACTIVE_COMPARATOR: MI Varnish; MI Fluoride Varnish was applied to the maxillary anterior teeth (canine to canine)	Device: MI Varnish; Fluoride varnish was applied every 4-6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enamel Decalcification Index	Extent and severity of white spot lesion formation	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Texas A&M University
• Investigators: Principal Investigator: Peter Buschang, PhD, Texas A&M University

Publications and helpful links

General Publications

• Banks PA, Richmond S. Enamel sealants: a clinical evaluation of their value during fixed appliance therapy. Eur J Orthod. 1994 Feb;16(1):19-25. doi: 10.1093/ejo/16.1.19.
• Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): February 10, 2020
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (ACTUAL): September 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Oral Hygiene; Orthodontics; White spot lesion; enamel decalcification
• Additional Relevant MeSH Terms: Skin Diseases; Exanthema
• Other Study ID Numbers: COD_Ortho2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual results of the study will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes