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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

Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE July 12, 2019
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Demineralization [ Time Frame: within 14 days after teeth extractions ]
    mineral density as determined by micro computed tomography (uCT)
  • Caries location [ Time Frame: within 14 days after teeth extractions ]
    Canary number that indicates early demineralization determined by the Canary System for caries identification
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish
Official Title  ICMJE 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
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE Demineralization
Intervention  ICMJE Device: CPP-ACP-NaF varnish
calcium phosphate containing fluoride releasing varnish to prevent caries
Study Arms  ICMJE
  • 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.
    Intervention: Device: CPP-ACP-NaF varnish
  • 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.
    Intervention: Device: CPP-ACP-NaF varnish
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 26, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 28, 2021
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002232
Other Study ID Numbers  ICMJE 19-0968
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Clifton Carey University of Colorado, SoDM
PRS Account University of Colorado, Denver
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP