An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy
Condition: Caries
Study type: Interventional

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.
    

Detailed description: 
      The evidence of milk fluoridation as a public health measure in caries prevention has been
      demonstrated in many clinical studies. While these data are encouraging, the main focus now
      should be on the optimization of milk fluoride programs. This protocol will concentrate on
      the parameters of fluoride dose and concentration utilizing an in situ model, the intra-oral
      caries test or model (ICT). The ICT is an established model which features the use of
      gauze-covered specimens to facilitate plaque growth and to simulate a caries-prone/plaque
      stagnation area. After subject has been consented and enrolled in the study per the
      inclusion/exclusion criteria, two to three days following a dental cleaning, two partially
      demineralized specimens will be placed in the buccal flange area of the subject's mandibular
      partial denture. During each of the five, three-week test periods, subjects will drink their
      assigned milk test product once per day for either five (100 ml milk) or ten (200 ml milk)
      timed minutes, wearing their mandibular partial dentures 24 hours a day during the test
      period. Fluoride free toothpaste will be used two to three days before and continuously
      during each treatment period. After each three-week test period, the two partially
      demineralized specimens will be removed from the subject's partial denture and analyzed using
      the surface microhardness test. Mineral content change (as percentage of surface
      microhardness recovery) in these artificially induced incipient enamel lesions will be the
      primary outcome variable. Each subject (n = 28) will serve as his or her own control.
    

Intervention name(s): 1.5 mg Sodium Fluoride in 100 ml milk; 1.5 mg sodium fluoride in 200 ml milk; 3 mg sodium fluoride in 100 ml milk; 3 mg sodium fluoride in 200 ml milk; Non-fluoridated milk, 200 ml
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Each subject will use this product during one of the five treatment periods in the crossover study design.; Each subject will use this product during one of the five treatment periods in the crossover study design.; Each subject will use this product during one of the five treatment periods in the crossover study design.; Each subject will use this product during one of the five treatment periods in the crossover study design; Each subject will use this product during one of the five treatment periods in the crossover study design.
Other intervention name(s): sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00); Kroger Nonfat Dry Milk reconstituted with fluoride-free milk; sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00); Kroger Nonfat Dry Milk reconstituted with fluoride-free milk; sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00); Kroger Nonfat Dry Milk reconstituted with fluoride-free milk; sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00); Kroger Nonfat Dry Milk reconstituted with fluoride-free milk; Kroger Nonfat Dry Milk
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: Caries