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

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT01566357
Collaborator
Borrow Foundation (Other)
15
1
7
18
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: Toothpaste
  • Dietary Supplement: Milk
  • Dietary Supplement: Fluoridated Milk
  • Drug: Tooth Mousse
  • Drug: MI Paste Plus
  • Drug: Elmex Erosion Protection
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Official Title:
Impact of Milk and Casein Phosphopeptide-amorphous Calcium Phosphate on Erosion/Abrasion of Enamel and Dentin - an in Situ Study
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Substance loss (profilometry) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Annette Wiegand, PD Dr. med. dent., PD Dr. med. dent., University of Zurich
ClinicalTrials.gov Identifier:
NCT01566357
Other Study ID Numbers:
  • 029/UZS
First Posted:
Mar 29, 2012
Last Update Posted:
Jul 18, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Annette Wiegand, PD Dr. med. dent., PD Dr. med. dent., University of Zurich

Study Results

No Results Posted as of Jul 18, 2013