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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-16

Study Completion Date

2019-04-12

Brief Summary

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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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Detailed Description

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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?

Conditions

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Cavities of Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Participants have at least two teeth planned for extraction on either side of the mouth. The study will use a split-mouth design with random assignments for intervention (OpalSeal) on one tooth.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Opalseal and TransbondXT are identical in color, consistency and application allowing random assignments as well as patient blinding.

The outcomes assessor will also be blinded to the groups assignments.

Study Groups

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OpalSeal

OpalSeal will be applied

1. to the buccal surfaces of to-be-extracted teeth on one side of the mouth which will be determined randomly for each participant during bonding of orthodontic brackets, or
2. to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm

Group Type EXPERIMENTAL

OpalSeal

Intervention Type DEVICE

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

Transbond XT

TransbondXT will be applied

1. to the buccal surfaces of to-be-extracted teeth on the other side of the mouth which will be determined based on which side received OpalSeal for each participant during bonding of orthodontic brackets, or
2. to the proximal surfaces following IPR in accordance to manufacturer instructions. Transbond XT does not have fluoride and hence would be considered as a placebo.

Group Type PLACEBO_COMPARATOR

TransbondXT

Intervention Type DEVICE

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

Interventions

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OpalSeal

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

Intervention Type DEVICE

TransbondXT

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No