None listed
Conditions
Brief summary
The aim of this study is to compare the repair of early tooth decay and penetration of fluoride into the repaired decay after mouthrinsing four times a day for 10 days with a solution of: 1) a tooth creme product containing fluoride and a major component of milk called casein; 2) an oral care product containing fluoride alone. 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. Subjects will insert their appliance, rinse with 5 mL of one of the two solutions for one minute, spit out the solution, then continue wearing the appliance for a total of 40 minutes. After 10 days' rinsing with one of the solutions, subjects will rest from the study for four days before repeating the exercise with the other solution as before. The research team will prepare the solutions by diluting the products in distilled filtered water. Solutions will be freshly prepared for use at the start of each weekday and enough solution for subjects to use on the weekends will be prepared on the Friday beforehand. Subjects will brush their teeth with a fluoride toothpaste at least one hour before first inserting their appliance that day and rinse their mouths with tap water and their appliance with distilled filtered water immediately prior to inserting their appliance each time. They will also rinse their appliance with distilled filtered water after removing it each time and store their appliance in a humid container at room temperature. Subjects will also be instructed to clean their appliance, avoiding the enamel pieces, with a fluoride-free denture paste once daily. The solutions will be stored at room temperature at all times. Subjects will not eat or drink anything except rinse with their allocated solution when wearing their appliance. Otherwise, subjects will maintain their normal oral hygiene and dietary habits throughout the study. The hypotheses for this study are: 1) there will be significantly greater repair of decay after rinsing with the solution containing casein and fluoride than after rinsing with the solution containing fluoride only. 2) penetration of fluoride into the repaired decay will be significantly greater after rinsing with the solution containing casein and fluoride than the solution containing fluoride alone.
Interventions
Rinsing with 1:4 dilutions in distilled deionized water of: 1) a tooth creme product containing 10% weight per volume(w/w) casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and 900 parts per million (ppm) sodium fluoride (final concentration 2% (w/v) CPP-ACP and 180 ppm fluoride); 2) an oral care product containing 5000 ppm sodium fluoride (final concentration 1000 ppm fluoride).
The subjects will each wear an upper removable custom-made denture-like appliance that will hold four pre-s
Rinsing with 1:4 dilutions in distilled deionized water of: 1) a tooth creme product containing 10% weight per volume(w/w) casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and 900 parts per million (ppm) sodium fluoride (final concentration 2% (w/v) CPP-ACP and 180 ppm fluoride); 2) an oral care product containing 5000 ppm sodium fluoride (final concentration 1000 ppm fluoride). The subjects will each wear an upper removable custom-made denture-like appliance that will hold four pre-sterilized enamel pieces each. These enamel pieces will contain artificially-created subsurface carious lesions. The appliances with attached enamel pieces will be worn by the subjects for 40 minutes four times a day for 10 consecutive days and worn immediately before rinsing with the solution. Subjects will also rinse with the solution for 60 seconds four times a day immediately after inserting the appliance each time. After 10 days, the enamel pieces will be removed from the appliance and replaced with new enamel pieces containing the subsurface lesions for the next treatment period. This is a cross over trial - each participant will rinse with either the intervention or control solution (randomly allocated) for the first 10 days and then crossover to rinse with the other solution for another 10 days after a four day washout period between.
Sponsors
The 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 bacteremia is present. pregnancy.
Outcome results
None listed