Erosion ProtectionNCT01566357
Impact of Milk on Erosion/Abrasion of Enamel and Dentin - an in Situ Study
A study testing Toothpaste, Milk and Fluoridated Milk in people with Erosion Protection, run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Erosion Protection
- What is being tested?
- Toothpaste, Milk and Fluoridated Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- non-treated caries lesions
- orthodontic treatment which does not allow to wear an intraoral device
- hyposalivation
- allergy against milk or milk proteins
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Preventive Dentistry, Periodontology and Cariology, University of Zurich
Zurich, Canton of Zurich, 8032
About this study
Official title: Impact of Milk and Casein Phosphopeptide-amorphous Calcium Phosphate 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)
Read the 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.
- Conditions
- Erosion Protection
- Being tested
- Toothpaste, Milk, Fluoridated Milk, Tooth Mousse, MI Paste Plus
- Keywords
- dental erosion, enamel, dentin
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToothpasteOther
MilkDietary supplement
Fluoridated MilkDietary supplement
Tooth MousseDrug
MI Paste PlusDrug
Elmex Erosion ProtectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Fluoride-free toothpaste | No intervention | Not described |
| Fluoride toothpaste | Active comparator | Not described Receives: Other: Toothpaste |
| Milk | Active comparator | Not described Receives: Dietary Supplement: Milk |
| Fluoridated milk | Active comparator | Not described Receives: Dietary Supplement: Fluoridated Milk |
| CPP-ACP | Active comparator | Not described Receives: Drug: Tooth Mousse |
| Fluoridated CPP-ACP | Active comparator | Not described Receives: Drug: MI Paste Plus |
| Fluoride mouthrinse | Active comparator | Not described Receives: Drug: Elmex Erosion Protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance loss (profilometry)
Each intervention will be tested for 5 days in situ. Then, enamel or dentin loss, respectively, will be determined by profilometry
Measured: after each study phase (5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Erosion ProtectionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Borrow Foundation
- Responsible party
- Principal investigator, Annette Wiegand, PD Dr. med. dent., University of Zurich
- Investigators
- Annette Wiegand, PD Dr. med. dent., Principal investigator, University of Zurich, SwitzerlandThomas Attin, Prof. Dr. med. dent., Study director, University of Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566357
- Sponsor's protocol ID
- 029/UZS
- Status last verified
- Jul 2013
- First submitted
- 27 Mar 2012
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18578180Hemingway 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.
PubMed 20980757White 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.
PubMed 21160185Wiegand 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.
PubMed 20083245Wiegand 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.
PubMed 25038509
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Milk and Casein Phosphopeptide-amorphous Calcium Phosphate on Erosion/Abrasion of Enamel and Dentin - an in Situ Study
- ClinicalTrials.gov ID
- NCT01566357
- Acronym / sponsor ID
- 029/UZS
- Conditions
- Erosion Protection
- Keywords
- dental erosion, enamel, dentin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Borrow Foundation
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (4 listed)
- non-treated caries lesions
- orthodontic treatment which does not allow to wear an intraoral device
- hyposalivation
- allergy against milk or milk proteins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothpaste | Other | Fluoride toothpaste |
| Milk | Dietary supplement | Milk |
| Fluoridated Milk | Dietary supplement | Fluoridated milk |
| Tooth Mousse | Drug | CPP-ACP |
| MI Paste Plus | Drug | Fluoridated CPP-ACP |
| Elmex Erosion Protection | Drug | Fluoride mouthrinse |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2013.
- Background: PubMed 18578180Wiegand 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.
- Background: PubMed 20980757Hemingway 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.
- Background: PubMed 21160185White 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.
- Background: PubMed 20083245Wiegand 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.
- Derived from this study: PubMed 25038509Wiegand 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.
Related trials for Erosion Protection
Recruiting
Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques
Mucosal Erosion, Gingival Recession
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Wiegand, PD Dr. med. dent. principal investigator
University of Zurich, Switzerland
Thomas Attin, Prof. Dr. med. dent. study director
University of Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste, Milk and Fluoridated Milk in people with Erosion Protection, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance loss (profilometry) (time frame: after each study phase (5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01566357, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2013.