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Trial registered on ANZCTR

Registration number

ACTRN12607000652471

Ethics application status

Approved

Date submitted

19/12/2007

Date registered

20/12/2007

Date last updated

29/06/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

The repair of early tooth decay after drinking milk containing added casein

Scientific title

An investigation of the capacity of casein phosphopeptide-amorphous calcium phosphate complexes (CPP-ACP) added to milk (100 mL) to remineralize enamel subsurface carious lesions in situ using an intraoral model.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dental decay

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Drinking milk containing added casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) at concentrations of: 0.2% weight per volume (w/v) and 0.3% (w/v) once a day for 15 consecutive weekdays each. On each day subjects will drink 100 mL of one of the milks taking between five and eight sips over 30 seconds. Subjects will drink one of the milks for 15 consecutive weekdays then rest for a week (washout period) before drinking the other milk for another 15 consecutive weekdays. Each subject will also wear a custom-made removable plastic denture-like appliance that will hold four pieces of pre-sterilized human tooth enamel containing artificially-created subsurface carious lesions. The appliances will be worn for 40 minutes each day the milks are consumed. The subjects will insert their appliance just before drinking the milks each time and continue to wear the appliance for the 40 minutes.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Milk containing no added CPP-ACP. Subjects will drink 100 mL of the control milk taking between five and eight sips over 30 seconds, once a day for 15 consecutive weekdays. Each subject will also wear a custom-made removable plastic denture-like appliance that will hold four pieces of pre-sterilized human tooth enamel containing artificially-created subsurface carious lesions. The subjects will insert their appliance just before drinking the control milk each time and continue to wear the appliance for the 40 minutes.

Control group

Placebo

Outcomes

Primary outcome [1]

Remineralization of artificially-created subsurface carious lesions measured by calculating the difference in mineral content of lesions exposed to the milk and the mineral content of the respective control lesions not exposed to the milk, using microdensitometric analysis of microradiographic images of the lesions.

Timepoint [1]

Mineral content measured once after drinking each milk once a day for 15 days.

Secondary outcome [1]

N/A

Timepoint [1]

N/A

Eligibility

Key inclusion criteria

Adults in good general and dental health.
Have at least 22 teeth.
Produce normal amounts of saliva (determined by measuring the volume of a two-minute unstimulated saliva sample and a two-minute stimulated saliva sample).

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Allergic or adverse reactions to milk or milk products.
History of dry mouth, or medical conditions or taking medication likely to cause xerostomia.
Bleeding disorders.
Infectious diseases including blood-borne diseases such as HIV/AIDS or Hepatitis C.
Active dental caries or periodontal diseases.
History of rheumatic heart disease, heart murmurs, etc. where risk of complications following bacteraemia is present.
pregnancy

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The institution will be provided with the products in coded packages. Participants will be enrolled after they have fulfilled inclusion criiteria and do not have any of the medical or dental conditions that would exclude them from the study. They will sign a written consent form before participating. Allocation of products to participants will be random. Each participant will be given a coded plastic bag each day containing fresh refigerated milk allocated to them. The code and, therefore, the sequence of treatments will be unknown to researchers and participants. In the case of a medical emergency, the code can be accessed for a single participant without breaking the blinding for other participants.
participants will drink one of the milks for 15 days then rest from the study for one week before repeating the exercise drinking another randomly allocated milk. This will again be repeated a third time until each participant has consumed all three milks for 15 days each with two one-week washout periods between.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A computer generated randomization procedure.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

This is a three-way crossover trial with two washout periods of one week each.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

7/01/2008

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

3052

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Meiji Dairies Corporation

Address [1]

1-2-10, Shinsuna, Koto-Ku, Tokyo 136-8908

Country [1]

Japan

Primary sponsor type

University

Name

University of Melbourne

Address

Grattan Street
Parkville
Victoria 3010

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Meiji Dairies Corporation

Address [1]

1-2-10, Shinsuna, Koto-Ku, Tokyo 136-8908

Country [1]

Japan

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Human Research Ethics Committee

Ethics committee address [1]

Ethics Office
Melbourne Research Office
Level 5
Alan Gilbert Building
161 Barry Street
University Square
Carlton 
Victoria 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/11/2007

Approval date [1]

12/12/2007

Ethics approval number [1]

0718140

Summary

Brief summary

The aim of this study is to compare the  repair of early tooth decay after drinking with three milks, each containing different amounts of added casein, (which is a major component of milk), once a day for 15 days. Subjects will wear a custom-made removable plastic denture-like appliance  that will each hold four pieces of pre-sterilized human tooth enamel containing early decay that has been artificially-created in the laboratory. On each of 15 consecutive weekdays, subjects will be given a coded bag containing their allocated milk to use that day by the research team. They will be instructed to pour out 100 mL of the milk from the bag into a plastic measuring cup (supplied). They will then rinse their mouths with tap water and rinse their appliance with distilled filtered water (supplied). They will then insert their appliance and drink all 100 mL of the milk by taking 5-8 sips over 30 seconds. They will then continue to wear their appliance for a total of 40 minutes. After the 40 minutes they will remove their appliance, rinse it with distilled filtered water and clean it, avoiding the enamel pieces as instructed, with a fluoride free denture paste (supplied). They will again rinse the appliance with distilled filtered water and store it in a humid container (supplied) at room temperature until required again. After 15 days' drinking one of the milks, subjects will rest from the study for a week before repeating the exercise with another milk as before. Subjects will repeat this again until they have consumed all three milks.
All milk will be stored at 4 degrees Celsius in a secure refigerator in the research department and milk will not be consumed if it has been stored for more than 60 days after its manufacture date. Subjects will also be instructed to consume their milk within 30 minutes of it being removed from the refrigerator and given to them by the research team. 
Subjects will brush their teeth with a fluoride toothpaste at least one hour before first inserting their appliance each day and also once at night. When wearing their appliance, subjects will not eat or drink anything other than drink their allocated milk. Otherwise, subjects will maintain their normal oral hygiene and dietary habits throughout the study.
The hypotheses for this study are:  
1) drinking milk containing added casein results in significantly greater repair of decay than drinking milk without added casein;
2) repair of decay after drinking milk with the highest amount of added casein is significantly greater than repair of decay after drinking with milk containing the lower amount of added casein.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Profesor Eric Reynolds AO

Address

School of Dental Science
University of Melbourne
720 Swanston Street
Melbourne
Victoria 3010

Country

Australia

Phone

(03) 9341 1547

Fax

(03) 9341 1596

e.reynolds @unimelb.edu.au

Contact person for scientific queries

Name

Professor Eric Reynolds AO

Address

School of Dental Science
University of Melbourne
720 Swanston Street
Melbourne
Victoria 3010

Country

Australia

Phone

(03) 9341 1547

Fax

(03) 9341 1596

e.reynolds @unimelb.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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