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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind and will utilize a 5-way cross-over study design with a primary objective to determine if a higher dose of fluoride in milk will provide a greater caries preventive effect. Secondary objectives are to determine in a higher concentration of fluoride in milk will provide a greater caries preventive effect and if the caries preventive effect of fluoridated milk follows a dose-response pattern.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Frank Lippert
• Collaborator: The Borrow Foundation
• Treatments: Fluorides; Listerine; Sodium Fluoride

Criteria

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