NCT04002232

Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 10 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Demineralization

Interventions

Type	Name	Description
DEVICE	CPP-ACP-NaF varnish	calcium phosphate containing fluoride releasing varnish to prevent caries

Timeline

• Start date: 2019-07-12
• Primary completion: 2019-12-05
• Completion: 2019-12-05
• First posted: 2019-06-28
• Last updated: 2021-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study