Clinical trial NCT01665911
Conditions: Caries
Keywords: Caries
Sponsor: Frank Lippert
Start date: 2012-08-01; Completion date: 2013-06-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief 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.

Arms: arm 1: non-fluoridated milk, 200 ml 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 arm 2: non-fluoridated milk, 200 ml 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 arm 3: non-fluoridated milk, 200 ml 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 arm 4: non-fluoridated milk, 200 ml 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 arm 5: non-fluoridated milk, 200 ml 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
Interventions: intervention 1: 1.5 mg Sodium Fluoride in 100 ml milk intervention 2: 1.5 mg sodium fluoride in 200 ml milk intervention 3: 3 mg sodium fluoride in 100 ml milk intervention 4: 3 mg sodium fluoride in 200 ml milk intervention 5: Non-fluoridated milk, 200 ml
Intervention descriptions: intervention 1: Each subject will use this product during one of the five treatment periods in the crossover study design. intervention 2: Each subject will use this product during one of the five treatment periods in the crossover study design. intervention 3: Each subject will use this product during one of the five treatment periods in the crossover study design. intervention 4: Each subject will use this product during one of the five treatment periods in the crossover study design intervention 5: Each subject will use this product during one of the five treatment periods in the crossover study design.

Protocol documents: