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

White Spot Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04560478
• Other study ID #: COD_Ortho2
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: September 2020
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesion

Intervention

Device:
• Pro Seal Sealant
Sealant was reapplied every 3 months
• MI Varnish
Fluoride varnish was applied every 4-6 weeks

Locations

Country	Name	City	State
United States	Texas A&M University College of Dentistry	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enamel Decalcification Index	Extent and severity of white spot lesion formation	12 months
Secondary	Location of White Spot Lesions	Mesial, Distal, Incisal or Gingival Region	12 months
Secondary	Most Common Tooth for White Spot Formation	Maxillary Canine, Lateral, or Central Incisor	12 Months
Secondary	Oral Hygiene Status	Measurement of plaque accumulation on maxillary teeth	12 Months
Secondary	Sex Differences	Male versus Female	12 Months