NCT04560478

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Texas A&M University · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• White Spot Lesion

Interventions

Type	Name	Description
DEVICE	Pro Seal Sealant	Sealant was reapplied every 3 months
DEVICE	MI Varnish	Fluoride varnish was applied every 4-6 weeks

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-02-10
• Completion: 2020-03-01
• First posted: 2020-09-23
• Last updated: 2020-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study