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

Erosion Protection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566357
• Other study ID #: 029/UZS
• Status: Completed
• Phase: N/A
• First received: March 27, 2012
• Last updated: July 17, 2013
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethics committee
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Erosion Protection

Intervention

Other:
• Toothpaste

Dietary Supplement:
• Milk

• Fluoridated Milk

Drug:
• Tooth Mousse

• MI Paste Plus

• Elmex Erosion Protection

Locations

Country	Name	City	State
Switzerland	Clinic for Preventive Dentistry, Periodontology and Cariology, University of Zurich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Borrow Foundation

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Hemingway CA, White AJ, Shellis RP, Addy M, Parker DM, Barbour ME. Enamel erosion in dietary acids: inhibition by food proteins in vitro. Caries Res. 2010;44(6):525-30. doi: 10.1159/000320984. Epub 2010 Oct 28. — View Citation

White AJ, Gracia LH, Barbour ME. Inhibition of dental erosion by casein and casein-derived proteins. Caries Res. 2011;45(1):13-20. doi: 10.1159/000322300. Epub 2010 Dec 11. — View Citation

Wiegand A, Hiestand B, Sener B, Magalhães AC, Roos M, Attin T. Effect of TiF4, ZrF4, HfF4 and AmF on erosion and erosion/abrasion of enamel and dentin in situ. Arch Oral Biol. 2010 Mar;55(3):223-8. doi: 10.1016/j.archoralbio.2009.11.007. Epub 2010 Jan 18. — View Citation

Wiegand A, Müller I, Schnapp JD, Werner C, Attin T. Impact of fluoride, milk and water rinsing on surface rehardening of acid softened enamel. An in situ study. Am J Dent. 2008 Apr;21(2):113-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance loss (profilometry)	Each intervention will be tested for 5 days in situ. Then, enamel or dentin loss, respectively, will be determined by profilometry	after each study phase (5 days)	No