- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04002232
Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish (CPP-ACP)
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
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.
Study Overview
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
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado School of Dental Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
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.
|
calcium phosphate containing fluoride releasing varnish to prevent caries
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demineralization
Time Frame: Up to 14 days after teeth extractions
|
mineral density as determined by micro computed tomography (uCT)
|
Up to 14 days after teeth extractions
|
Caries location
Time Frame: Up to14 days after teeth extractions
|
Canary number that indicates early demineralization determined by the Canary System for caries identification
|
Up to14 days after teeth extractions
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Clifton Carey, University of Colorado, SoDM
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19-0968
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Demineralization
-
Cairo UniversityUnknownDemineralization, Tooth | Demineralization, Fissure | Non-Cavitated Caries
-
Nantes University HospitalTerminatedBone Demineralization Lesions in the Injured MarrowFrance
-
PfizerActive, not recruitingMenopause | Bone DemineralizationKorea, Republic of
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedHypoestrogenism | Bone Demineralization | Subclinical Kidney Injury | Bone MicroarchitectureUganda
-
Shriners Hospitals for ChildrenCompletedBurns | Bone DemineralizationUnited States
-
University College DublinRush University Medical Center; Royal College of Surgeons, Ireland; Mater Misericordiae... and other collaboratorsTerminatedBone DemineralizationIreland
-
The University of Hong KongUnknownWhite Spot Lesion | Caries,Dental | Demineralization, ToothHong Kong
-
Hacettepe UniversityCompletedTooth DemineralizationTurkey
-
Universidad Autonoma de San Luis PotosíUnknownTooth DemineralizationMexico
-
Mondelēz International, Inc.University of LiverpoolNot yet recruitingTooth Demineralization
Clinical Trials on CPP-ACP-NaF varnish
-
Cairo UniversityRecruiting
-
The University of Hong KongResearch Grants Council, Hong KongUnknownEarly Childhood CariesHong Kong
-
Azad University of Medical SciencesCompletedMucositis | Infection | Dry MouthIran, Islamic Republic of
-
University of New EnglandUniversity of IowaCompletedTooth Discoloration | Teeth SensitivityUnited States
-
Rania SalahQueen Mary University of LondonCompleted
-
Indira Gandhi Institute of Dental ScienceCompletedEvaluation of Remineralizing Efficacy of Combination Varnishes on White Spot Lesions in ECC ChildrenChild | Early Childhood Caries
-
Cairo UniversityUnknown
-
University of California, San FranciscoCompletedDental Caries | Dental White SpotsUnited States
-
University of WashingtonPacific NW Dental Practice-Based Research NetworkCompletedTooth DemineralizationUnited States