CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 30 enrolled
Drug / intervention
CPP-ACP-NaF varnishdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04002232
NCT04002232Early Ph 1Completed

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

University of Colorado, Denver·interventional·Posted Jun 28, 2019·Updated Jun 7, 2021

In Brief

A Early Phase 1 clinical trial evaluating CPP-ACP-NaF varnish for Demineralization. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
2020202120222023202420252026
First PostedJun 28, 2019
Enrollment StartJul 12, 2019
Primary CompletionDec 5, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.0 years ago

Interventions

CPP-ACP-NaF varnishdevice

calcium phosphate containing fluoride releasing varnish to prevent caries