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Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish

NCT04002232 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-06-07

No results posted yet for this study

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.

Conditions

  • Demineralization

Interventions

DEVICE

CPP-ACP-NaF varnish

calcium phosphate containing fluoride releasing varnish to prevent caries

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Clifton Carey · University of Colorado, SoDM

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-12
Primary Completion
2019-12-05
Completion
2019-12-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04002232 on ClinicalTrials.gov