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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 : Active, not recruiting
First Posted : June 28, 2019
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.


Condition or disease Intervention/treatment Phase
Demineralization Device: CPP-ACP-NaF varnish Early Phase 1

Detailed Description:

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.

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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 10, 2019
Estimated Study Completion Date : June 28, 2021

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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Colorado
University of Colorado School of Dental Medicine
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Clifton Carey University of Colorado, SoDM
Publications of Results:
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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: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes