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OpenTrials
Completed

NCT Number: NCT03722264

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

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.

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Key information

Conditions

Cavities of Teeth Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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):

  • Around the brackets called White Spot Lesions and
  • Along the sides of the teeth after slenderization procedure called inter-proximal reduction (IPR).

Our research questions are:

  • Can OpalSeal offer protection against white spot lesions (WSL) around the brackets?
  • Can OpalSeal offer protection against decay on the sides of teeth following IPR?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

OpalSeal

Device

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

TransbondXT

Device

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

Primary outcomes

  1. Loss of Mineral Density in the Enamel

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

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

Secondary outcomes

  1. Surface Topography and Hardness

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

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

  2. Retention of OpalSeal

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

    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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients. A Pilot Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2018
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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