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

Study Overview
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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.

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): 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?

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

Conditions
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Cavities of Teeth

Intervention / Treatment
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* Device: OpalSeal
* Device: TransbondXT


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OpalSeal<br>OpalSeal will be applied 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 to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm | Device: OpalSeal<br>* OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets<br>|
| Placebo Comparator: Transbond XT<br>TransbondXT will be applied 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 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. | Device: TransbondXT<br>* Transbond is a primer used to bond orthodontic brackets that does not contain fluoride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 from initial bonding to extraction (max 90 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface Topography and Hardness | Scanning electron microscopy and atomic force microscopy will be used to evaluate the protective effect of OpalSeal | 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 from initial bonding to extraction (max 90 days) |