Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Demineralization

In brief

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.

Key facts

Study ID

NCT04002232

Run by

University of Colorado, Denver

People needed

30

Starts

2019-07-12

Expected to finish

2019-12-05

Last updated by the study team

2021-06-07

Who can join

Age: 10 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Colorado School of Dental Medicine — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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