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Completed

NCT Number: NCT01566357

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

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)

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for Preventive Dentistry, Periodontology and Cariology, University of Zurich

Zurich, Canton of Zurich, 8032, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

toothpaste

Other

Milk

Dietary Supplement

Fluoridated Milk

Dietary Supplement

Tooth Mousse

Drug

MI Paste Plus

Drug

Elmex Erosion Protection

Drug

Primary outcomes

  1. Substance loss (profilometry)

    Time frame: after each study phase (5 days)

    Each intervention will be tested for 5 days in situ. Then, enamel or dentin loss, respectively, will be determined by profilometry

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Borrow Foundation

Registry information

Official study title

Impact of Milk and Casein Phosphopeptide-amorphous Calcium Phosphate on Erosion/Abrasion of Enamel and Dentin - an in Situ Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 29, 2012
Registry last updated
Jul 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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