An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients

Virginia Commonwealth University12 enrolled

Overview

Fluoride is very effective in preventing dental decay (cavities) when applied in the form of a varnish on tooth surfaces. The purpose of this study is to verify if fluoride-releasing primer (OpalSeal) offers more protection against early dental decay (cavity) compared to conventional primer (Transbond XT) during treatment with braces.

Primers are a type of 'glue' routinely used in orthodontics to attach brackets (metallic components) to the teeth. OpalSeal is a fluoride-releasing primer that has the potential to reduce cavities in patients receiving braces. Orthodontic patients are at particular risk of developing two types of early carious lesions (decay): 1. Around the brackets called White Spot Lesions and 2. Along the sides of the teeth after slenderization procedure called inter-proximal reduction (IPR). Our research questions are: 1. Can OpalSeal offer protection against white spot lesions (WSL) around the brackets? 2. Can OpalSeal offer protection against decay on the sides of teeth following IPR?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Cavities of Teeth

Interventions

OpalSealDEVICE

OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets

TransbondXTDEVICE

Transbond is a primer used to bond orthodontic brackets that does not contain fluoride

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients age 10 and older seeking treatment at the VCU Orthodontics Clinic who require extraction of at least 2 teeth for orthodontic purposes * Such teeth should be free of any developmental defects Exclusion Criteria: * Patients under 10 years of age * Patients with defective teeth * Those who cannot provide consent/assent OR not able to follow research protocols * Protected population (prisoners)

Locations (1)

School of Dentistry, Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Loss of Mineral Density in the Enamel

Teeth will be subjected to microCT to assess the extent of demineralization. Loss of mineral density will be measured as depth of lesions

Time frame: Time from initial bonding to extraction (max 90 days)

Secondary Outcomes

Surface Topography and Hardness

Scanning electron microscopy and atomic force microscopy will be used to evaluate the protective effect of OpalSeal

Time frame: Time from initial bonding to extraction (max 90 days)

Retention of OpalSeal

The protective effects of OpalSeal is subject to its retention at the site of application. Since OpalSeal fluoresces under black light, its retention will be evaluated

Time frame: Time from initial bonding to extraction (max 90 days)

Data from ClinicalTrials.gov

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