An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy

Inclusion Criteria

• sign an informed consent, authorization for the release of health information for research and provide medical history information, including medications, prior to their participation;
• be between 18 and 80 years old and in general good health;
• willingness to use a reliable form of contraception or abstaining during the course of the study (females of child-bearing potential only)
• wear a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two enamel specimens (required dimensions 12×7 mm);
• be willing and capable of wearing their removable mandibular partial dentures 24 hours a day for a total of five, three-week test periods;
• be in good dental health with no active caries or periodontal disease;
• agree to comply with all subjects' responsibilities as stated in the protocol (e.g. use of study products, attendance at appointments, etc.);
• have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 ml/min; gum base stimulated whole saliva flow rate ≥ 0.8 ml/min).
• Be able to tolerate the taste and room temperature of the mixed milk product as demonstrated by drinking the milk at screening

Exclusion Criteria

be pregnant, intending to become pregnant during the study period or breast feeding. A urine pregnancy test will be required at screening, the start of each treatment visit and the last study visit for all subjects of child-bearing potential to confirm the subject is not pregnant.

• have any medical condition that could be expected to interfere with the subject's safety during the study period;
• demonstrate an inability to comply with study procedures;
• have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications that prohibit the safe conduct of a dental cleaning* or previous use of the weight loss medications Fen Phen® or Redux®. (*Note: Subjects who are taking blood thinners in which written verification is obtained from their physician indicating their PT/INR levels (anti-coagulation blood levels) are at an acceptable level to avoid serious complications, such as bleeding during dental cleanings, may be accepted into the study at the discretion of the Investigator.)
• be currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.
• be lactose intolerant or have known allergy or intolerance to milk or milk products