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

Sponsor

Texas A&M University (Other)

Overall Status

Completed

CT.gov ID

NCT04560478

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
White Spot Lesion	Device: Pro Seal Sealant Device: MI Varnish	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

single center, parallel, randomized clinical trialsingle center, parallel, randomized clinical trial

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Feb 10, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Enamel Decalcification Index [12 months]
Extent and severity of white spot lesion formation

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas A&M University College of Dentistry	Dallas	Texas	United States	75246

Sponsors and Collaborators

Texas A&M University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Texas A&M University

ClinicalTrials.gov Identifier:

NCT04560478

Other Study ID Numbers:

COD_Ortho2

First Posted:

Sep 23, 2020

Last Update Posted:

Sep 23, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Texas A&M University

Oral Hygiene

Orthodontics

White spot lesion

enamel decalcification

Additional relevant MeSH terms:

Exanthema

Study Results

No Results Posted as of Sep 23, 2020