None listed
Conditions
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.
Interventions
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 wil
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.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
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).
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
Outcome results
None listed