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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 2645 0
Condition category
Condition code
Oral and Gastrointestinal 2759 2759 0 0
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] 2380 0
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] 3646 0
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] 3646 0
Mineral content measured once after drinking each milk once a day for 15 days.
Secondary outcome [1] 6121 0
N/A
Timepoint [1] 6121 0
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
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 350 0
3052

Funding & Sponsors
Funding source category [1] 2903 0
Commercial sector/Industry
Name [1] 2903 0
Meiji Dairies Corporation
Country [1] 2903 0
Japan
Primary sponsor type
University
Name
University of Melbourne
Address
Grattan Street
Parkville
Victoria 3010
Country
Australia
Secondary sponsor category [1] 2621 0
Commercial sector/Industry
Name [1] 2621 0
Meiji Dairies Corporation
Address [1] 2621 0
1-2-10, Shinsuna, Koto-Ku, Tokyo 136-8908
Country [1] 2621 0
Japan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4844 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 4844 0
Ethics Office
Melbourne Research Office
Level 5
Alan Gilbert Building
161 Barry Street
University Square
Carlton
Victoria 3052
Ethics committee country [1] 4844 0
Australia
Date submitted for ethics approval [1] 4844 0
20/11/2007
Approval date [1] 4844 0
12/12/2007
Ethics approval number [1] 4844 0
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 28251 0
Address 28251 0
Country 28251 0
Phone 28251 0
Fax 28251 0
Email 28251 0
Contact person for public queries
Name 11408 0
Profesor Eric Reynolds AO
Address 11408 0
School of Dental Science
University of Melbourne
720 Swanston Street
Melbourne
Victoria 3010
Country 11408 0
Australia
Phone 11408 0
(03) 9341 1547
Fax 11408 0
(03) 9341 1596
Email 11408 0
e.reynolds @unimelb.edu.au
Contact person for scientific queries
Name 2336 0
Professor Eric Reynolds AO
Address 2336 0
School of Dental Science
University of Melbourne
720 Swanston Street
Melbourne
Victoria 3010
Country 2336 0
Australia
Phone 2336 0
(03) 9341 1547
Fax 2336 0
(03) 9341 1596
Email 2336 0
e.reynolds @unimelb.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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