Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish (CPP-ACP)

• ClinicalTrials.gov Identifier: NCT04002232
• Recruitment Status: Active, not recruiting
• First Posted: June 28, 2019
• Last Update Posted: October 22, 2020
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Tracking Information

• First Submitted Date: June 26, 2019
• First Posted Date: June 28, 2019
• Last Update Posted Date: October 22, 2020
• Actual Study Start Date: July 12, 2019
• Actual Primary Completion Date: December 10, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish
• 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

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: Interventional
• Study Phase: Early Phase 1

Study Design

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: Demineralization

Intervention

Device: CPP-ACP-NaF varnish

calcium phosphate containing fluoride releasing varnish to prevent caries

Study Arms

• 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 *

• Marinho VC, Higgins JP, Logan S, Sheiham A. Topical fluoride (toothpastes, mouthrinses, gels or varnishes) for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2003;(4):CD002782. Review.
• Nalbantgil D, Oztoprak MO, Cakan DG, Bozkurt K, Arun T. Prevention of demineralization around orthodontic brackets using two different fluoride varnishes. Eur J Dent. 2013 Jan;7(1):41-7.
• Reynolds EC. Remineralization of enamel subsurface lesions by casein phosphopeptide-stabilized calcium phosphate solutions. J Dent Res. 1997 Sep;76(9):1587-95.
• Srivastava K, Tikku T, Khanna R, Sachan K. Risk factors and management of white spot lesions in orthodontics. J Orthod Sci. 2013 Apr;2(2):43-9. doi: 10.4103/2278-0203.115081. Review.
• Todd MA, Staley RN, Kanellis MJ, Donly KJ, Wefel JS. Effect of a fluoride varnish on demineralization adjacent to orthodontic brackets. Am J Orthod Dentofacial Orthop. 1999 Aug;116(2):159-67.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 26, 2019): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 28, 2021
• Actual Primary Completion Date: December 10, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 80 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04002232
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: University of Colorado, Denver
• Study Sponsor: University of Colorado, Denver
• Collaborators: Not Provided

Investigators

• Principal Investigator: Clifton Carey; University of Colorado, SoDM

• PRS Account: University of Colorado, Denver
• Verification Date: October 2020