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

Texas A&M University40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

White Spot Lesion

Interventions

Pro Seal SealantDEVICE

Sealant was reapplied every 3 months

MI VarnishDEVICE

Fluoride varnish was applied every 4-6 weeks

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Texas A&M University College of Dentistry

Dallas, Texas, United States

Outcomes

Primary Outcomes

Enamel Decalcification Index

Extent and severity of white spot lesion formation

Time frame: 12 months

Secondary Outcomes

Location of White Spot Lesions

Mesial, Distal, Incisal or Gingival Region

Time frame: 12 months

Most Common Tooth for White Spot Formation

Maxillary Canine, Lateral, or Central Incisor

Time frame: 12 Months

Oral Hygiene Status

Measurement of plaque accumulation on maxillary teeth

Time frame: 12 Months

Sex Differences

Male versus Female

Time frame: 12 Months

Data from ClinicalTrials.gov

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