Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish

NCT04002232 | Completed Early Phase 1 FDA Device

• 1 other identifier: 19-0968
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Demineralization

Outcome Measures

Primary Outcomes (2)

• Demineralization

  mineral density as determined by micro computed tomography (uCT)

  Up to 14 days after teeth extractions

• Caries location

  Canary number that indicates early demineralization determined by the Canary System for caries identification

  Up to14 days after teeth extractions

Study Arms (2)

CPP-ACP-NaF

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

CPP-ACP-NaF varnish DEVICE

calcium phosphate containing fluoride releasing varnish to prevent caries

CPP-ACP-NaF; Placebo

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado School of Dental Medicine

Aurora, Colorado, 80045, United States

Location

Related Publications (5)

• 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;2003(4):CD002782. doi: 10.1002/14651858.CD002782.

  PMID: 14583954 RESULT

• 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.

  PMID: 23408742 RESULT

• Reynolds EC. Remineralization of enamel subsurface lesions by casein phosphopeptide-stabilized calcium phosphate solutions. J Dent Res. 1997 Sep;76(9):1587-95. doi: 10.1177/00220345970760091101.

  PMID: 9294493 RESULT

• 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.

  PMID: 24987641 RESULT

• 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. doi: 10.1016/s0889-5406(99)70213-1.

  PMID: 10434089 RESULT

Study Officials

• Clifton Carey

  University of Colorado, SoDM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split mouth

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: July 12, 2019
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)