NCT01566357

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 18, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

March 27, 2012

Last Update Submit

July 17, 2013

Conditions

Erosion Protection

Keywords

dental erosionenameldentin

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (7)

Fluoride-free toothpaste

NO INTERVENTION

Fluoride toothpaste

ACTIVE COMPARATOR
Other: Toothpaste

Milk

ACTIVE COMPARATOR
Dietary Supplement: Milk

Fluoridated milk

ACTIVE COMPARATOR
Dietary Supplement: Fluoridated Milk

CPP-ACP

ACTIVE COMPARATOR
Drug: Tooth Mousse

Fluoridated CPP-ACP

ACTIVE COMPARATOR
Drug: MI Paste Plus

Fluoride mouthrinse

ACTIVE COMPARATOR
Drug: Elmex Erosion Protection

Interventions

ToothpasteOTHER
Fluoride toothpaste
MilkDIETARY_SUPPLEMENT
Milk
Fluoridated MilkDIETARY_SUPPLEMENT
Fluoridated milk
Tooth MousseDRUG
CPP-ACP
MI Paste PlusDRUG
Fluoridated CPP-ACP
Elmex Erosion ProtectionDRUG
Fluoride mouthrinse

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • non-treated caries lesions
  • orthodontic treatment which does not allow to wear an intraoral device
  • hyposalivation
  • allergy against milk or milk proteins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Zurich, Canton of Zurich, 8032, Switzerland

Location

Related Publications (5)

  • Wiegand A, Muller 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.

    PMID: 18578180BACKGROUND

  • 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.

    PMID: 20980757BACKGROUND

  • 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.

    PMID: 21160185BACKGROUND

  • Wiegand A, Hiestand B, Sener B, Magalhaes 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.

    PMID: 20083245BACKGROUND

  • Wiegand A, Attin T. Randomised in situ trial on the effect of milk and CPP-ACP on dental erosion. J Dent. 2014 Sep;42(9):1210-5. doi: 10.1016/j.jdent.2014.07.009. Epub 2014 Jul 17.

    PMID: 25038509DERIVED

MeSH Terms

Conditions

Tooth Erosion

Interventions

ToothpastesMilkcasein phosphopeptide-amorphous calcium phosphate nanocomplex

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesTooth Wear

Intervention Hierarchy (Ancestors)

DentifricesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Annette Wiegand, PD Dr. med. dent.

    University of Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

  • Thomas Attin, Prof. Dr. med. dent.

    University of Zurich, Switzerland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. dent.

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 29, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

July 18, 2013

Record last verified: 2013-07

Locations

CH(1)