Evaluation of the Fluoride Dose Response of a Modified In Situ Caries Model
Condition: Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the fluoride dose response of different dentifrice
      fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model
      involving the use of human enamel specimens placed in the buccal flange area of the subjects
      partial denture with the modified model involving placement of bovine enamel specimens in a
      denture tooth location.
    

Detailed description: 
      This will be a double blind, single center, 4-way crossover design study involving 34 adult
      subjects, between the ages of 18 and 85 years. Two to three days before the start of each
      treatment period the subjects will have their teeth cleaned to remove all accessible plaque
      and calculus and will be provided with a non-fluoride dentifrice to use until their next
      visit. At the beginning of each testing period, two gauze-covered 4 × 4 mm partially
      demineralized human enamel specimens will be placed in the buccal flange area of the
      subject's mandibular partial denture. In addition, two gauze-covered 4 mm round partially
      demineralized bovine enamel specimens will be placed in the buccal surface of two posterior
      denture teeth of the same side of the partial denture. Once specimens are placed, subjects
      will wear their partial dentures twenty-four hours a day and use their assigned toothpaste
      twice daily, as instructed, until their next visit. Specimens will be removed after two weeks
      and the subjects will undergo a four to five day washout period followed by another cleaning
      and two to three day lead in period. This process will be repeated until all subjects have
      used all four test products. Changes in the mineral content of the enamel specimens will be
      assessed using the SMH and TMR. Enamel fluoride uptake (EFU) will be determined using the
      microdrill enamel biopsy technique. In addition the net acid resistance (NAR) and the
      comparative acid resistance (CAR) of the remineralized enamel specimens will be determined.
    

Intervention name(s): 0 ppm F (placebo, negative control); 250 ppm F as NaF (dose-response control); 500 ppm F as NaF (dose-response control); 1100 ppm F as NaF (positive control)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Each subject will use this product during one of the four treatment periods in the crossover study design.; Each subject will use this product during one of the four treatment periods in the crossover study design.; Each subject will use this product during one of the four treatment periods in the crossover study design.; Each subject will use this product during one of the four treatment periods in the crossover study design.
Other intervention name(s): Sensodyne sodium fluoride/silica toothpaste base formulation; Sensodyne sodium fluoride/silica toothpaste base formulation; Sensodyne sodium fluoride/silica toothpaste base formulation; Sensodyne sodium fluoride/silica toothpaste base formulation
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Caries