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Impact of Milk on Erosion/Abrasion of Enamel and Dentin - an in Situ Study

This study has been completed.
Sponsor:
Collaborator:
Borrow Foundation
Information provided by (Responsible Party):
Annette Wiegand, PD Dr. med. dent., University of Zurich
ClinicalTrials.gov Identifier:
NCT01566357
First received: March 27, 2012
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

This in situ study aims to investigate

  • the protective potential of milk and fluoridated milk on erosive wear of enamel
  • the protective potential of milk and fluoridated milk on erosive wear of dentin
  • to compare to protective potential of milk and fluoridated milk with products containing casein phosphopeptide-amorphous calcium phosphate
  • to compare the protective potential of milk and fluoridated milk with a fluoridated toothpaste or stannous-chloride containing fluoride solution (SnCl2/AmF/NaF)

Condition Intervention
Erosion Protection
Other: Toothpaste
Dietary Supplement: Milk
Dietary Supplement: Fluoridated Milk
Drug: Tooth Mousse
Drug: MI Paste Plus
Drug: Elmex Erosion Protection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Impact of Milk and Casein Phosphopeptide-amorphous Calcium Phosphate on Erosion/Abrasion of Enamel and Dentin - an in Situ Study

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Substance loss (profilometry) [ Time Frame: after each study phase (5 days) ] [ Designated as safety issue: No ]
    Each intervention will be tested for 5 days in situ. Then, enamel or dentin loss, respectively, will be determined by profilometry


Enrollment: 15
Study Start Date: January 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Fluoride-free toothpaste
Active Comparator: Fluoride toothpaste Other: Toothpaste
Active Comparator: Milk Dietary Supplement: Milk
Active Comparator: Fluoridated milk Dietary Supplement: Fluoridated Milk
Active Comparator: CPP-ACP Drug: Tooth Mousse
Active Comparator: Fluoridated CPP-ACP Drug: MI Paste Plus
Active Comparator: Fluoride mouthrinse Drug: Elmex Erosion Protection

Detailed Description:

Dental erosion is defined as the pathogenic, chronic, chemical removal of dental hard tissues due to the frequent contact to extrinsic or intrinsic acids. The dissolution process is determined by the pH, the chelating properties, mineral content and kind of acid, but in the same time modified by various biological (e.g. saliva, pellicle) and behavioural factors.

The anticariogenic properties of milk are widely investigated, but information of the effects of milk or milk components on the development of erosion are limited. It is suggested that the demineralisation process is reduced by the presence of calcium and phosphate, but also that casein proteins affect the demineralisation by adsorbing to the hydroxyapatite surface and inhibiting its dissolution. Initial studies suggest that milk is able to increase rehardening of acid-softened enamel, but information about the effects of milk on dentin erosion are not available yet. Particularly, the effect of fluoridated milk on dental erosion was not investigated yet.

In contrast, recent studies analysed the effects of products containing casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) on erosion, as it is suggested that CPP-ACP promotes a supersaturated state and increased remineralisation of demineralised dental hard tissue. However, in situ studies on the effect of CPP-ACP on erosion are limited to one study, which compared microhardness of enamel after treatment with CPP-ACP and CPP-ACP and 900 ppm fluoride, but failed to use appropriate controls in form of other products containing calcium and phosphate or fluoride. In summary, the effects of milk, in particular fluoridated milk, and products containing milk proteins, such as casein phosphopeptide-amorphous calcium phosphate, on erosive wear were not analysed in an in-situ-model so far.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • non-treated caries lesions
  • orthodontic treatment which does not allow to wear an intraoral device
  • hyposalivation
  • allergy against milk or milk proteins
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566357

Locations
Switzerland
Clinic for Preventive Dentistry, Periodontology and Cariology, University of Zurich
Zürich, Switzerland, 8032
Sponsors and Collaborators
University of Zurich
Borrow Foundation
Investigators
Principal Investigator: Annette Wiegand, PD Dr. med. dent. University of Zurich, Switzerland
Study Director: Thomas Attin, Prof. Dr. med. dent. University of Zurich, Switzerland