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NCT Number: NCT04002232

Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish

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.

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Key information

Conditions

Demineralization

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Colorado School of Dental Medicine

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

CPP-ACP-NaF varnish

Device

calcium phosphate containing fluoride releasing varnish to prevent caries

Primary outcomes

  1. Demineralization

    Time frame: Up to 14 days after teeth extractions

    mineral density as determined by micro computed tomography (uCT)

  2. Caries location

    Time frame: Up to14 days after teeth extractions

    Canary number that indicates early demineralization determined by the Canary System for caries identification

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Acronym: CPP-ACP

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2019
Registry last updated
Jun 7, 2021

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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