Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish (CPP-ACP)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04002232 |
Recruitment Status :
Completed
First Posted : June 28, 2019
Last Update Posted : June 7, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Demineralization | Device: CPP-ACP-NaF varnish | Early Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Split mouth |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | The placebo and the CPP-ACP-NaF varnishes will be supplied by the manufacturer labeled as either A or B. The blinding code is provided in a sealed envelop should there be a need to unblind the experiments. |
Primary Purpose: | Prevention |
Official 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 |
Actual Study Start Date : | July 12, 2019 |
Actual Primary Completion Date : | December 5, 2019 |
Actual Study Completion Date : | December 5, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: CPP-ACP-NaF
Dental varnish that contains calcium phosphoprotein stabilized amorphous calcium phosphate and sodium fluoride (CPP-ACP-NaF) is applied to the teeth with orthodontic brackets on one side of the mouth immediately after the teeth have received the bracket.
|
Device: CPP-ACP-NaF varnish
calcium phosphate containing fluoride releasing varnish to prevent caries |
Placebo Comparator: Placebo
Dental varnish base that does not contain calcium phosphoprotein stabilized amorphous calcium phosphate and sodium fluoride (CPP-ACP-NaF) is applied to the teeth with orthodontic brackets on one side of the mouth immediately after the teeth have received the bracket.
|
Device: CPP-ACP-NaF varnish
calcium phosphate containing fluoride releasing varnish to prevent caries |
- Demineralization [ Time Frame: Up to 14 days after teeth extractions ]mineral density as determined by micro computed tomography (uCT)
- Caries location [ Time Frame: Up to14 days after teeth extractions ]Canary number that indicates early demineralization determined by the Canary System for caries identification

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002232
United States, Colorado | |
University of Colorado School of Dental Medicine | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Clifton Carey | University of Colorado, SoDM |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT04002232 |
Other Study ID Numbers: |
19-0968 |
First Posted: | June 28, 2019 Key Record Dates |
Last Update Posted: | June 7, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |