Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish

Study Overview
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Brief Summary
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Sometimes when people wear braces, the combination of dental plaque and diets high in sugar and acids can lead to white spots on the teeth surrounding the braces. These are commonly found in people with braces depending on their diet and care of their teeth. The white spots will still be present when the braces are removed. These white spots are the beginning signs of cavities and show that mineral has been lost from the tooth. This study will be testing a new varnish that is painted on the tooth around the braces to prevent these white spots from forming. This study will enroll patients who wear braces and have planned teeth extractions. A calcium and fluoride releasing varnish will be painted on the teeth planned to be extracted. Braces will then be placed on the teeth. In 3-6 weeks, the extraction will occur and the teeth will be collected for analysis.

Detailed Description
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This is a randomized split mouth double blinded clinical trial. The CPP-ACP-NaF varnish is commercially available and is used for the treatment of tooth hypersensitivity under FDA 510K K102808. The placebo for this study is the same product without the CPP-ACP-NaF component. Patients with planned orthodontic therapy that include tooth extractions will have orthodontic brackets attached to the to-be-extracted teeth. Each patient will have the CPP-ACP-NaF varnish and the varnish base (without CPP-ACP-NaF) applied to teeth immediately after orthodontic brackets have been applied. The specific teeth (left or right) will be randomly determined as to the application of the varnish or placebo. In this experimental design each patient has CPP-ACP-NaF applied to one side and placebo applied to the other side. When the teeth are extracted they are transferred to the Carey Laboratory for in vitro evaluations.

Official Title
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Prevention of Enamel Demineralization in Fixed Appliance Orthodontic Patients Using CPP-ACP-NaF Varnish Compared to Blank Varnish Base. A Randomized Split Mouth Controlled Clinical Trial

Conditions
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Demineralization

Intervention / Treatment
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* Device: CPP-ACP-NaF varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at the University of Colorado School of Dental Medicine Department of Orthodontics who agree to consent to this study. Orthodontic treatment plans that include fixed appliances from the second premolar to second premolar in both arches. Orthodontic treatment plans that include extractions of at least 3 bicuspids for orthodontic therapy At least 10 years of age The patient has adequate oral hygiene Exclusion Criteria: Evidence of decalcification or restorations on any of the premolars planned for extraction prior to orthodontic treatment Younger than 10 years of age Allergies to cow's milk or cow's milk products Any condition that contraindicates orthodontic treatment, or are not willing to consent to the study.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split mouth
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPP-ACP-NaF<br>Dental varnish that contains calcium phosphoprotein stabilized amorphous calcium phosphate and sodium fluoride (CPP-ACP-NaF) is applied to the teeth with orthodontic brackets on one side of the mouth immediately after the teeth have received the bracket. | Device: CPP-ACP-NaF varnish<br>* calcium phosphate containing fluoride releasing varnish to prevent caries<br>|
| Placebo Comparator: Placebo<br>Dental varnish base that does not contain calcium phosphoprotein stabilized amorphous calcium phosphate and sodium fluoride (CPP-ACP-NaF) is applied to the teeth with orthodontic brackets on one side of the mouth immediately after the teeth have received the bracket. | Device: CPP-ACP-NaF varnish<br>* calcium phosphate containing fluoride releasing varnish to prevent caries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demineralization | mineral density as determined by micro computed tomography (uCT) | Up to 14 days after teeth extractions | 
| Caries location | Canary number that indicates early demineralization determined by the Canary System for caries identification | Up to14 days after teeth extractions |