In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste
Condition: Tooth Erosion
MeSH terms: Tooth Erosion
Study type: Interventional
Phase: Phase 3

Summary: 
      This will be a randomized, controlled, single center, single- blind, 3 period, 3 treatment,
      cross-over, in situ design which consists of placing pre-eroded bovine enamel specimens intra
      orally using a palatal appliance and testing the remineralizing performance of the
      experimental (dentifrice containing 0.254 Percent weight by weight [%, w/w] sodium fluoride
      (1150 parts per million [ppm] fluoride) and 5% KNO3 [potassium nitrate]), comparator
      (dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) and placebo (Fluoride
      free placebo containing 5% KNO3 [0 ppm fluoride] ) dentifrices 2 and 4 hours (hrs) post
      treatment application, based on surface micro hardness measurements. This study will be
      carried out in healthy adults with a maxillary dental arch suitable for the retention of the
      palatal appliance.
    

Detailed description: 
      The aim of this study is to investigate the performance of an experimental dentifrice
      formulation in promoting enamel remineralization and inhibiting post-treatment enamel
      demineralization in an in situ erosion model, in comparison with a fluoride-free placebo and
      with a marketed competitor dentifrice product. The study will have 4 visits, 1 screening
      visit to assess participants eligibility and 3 treatment visits to assess product efficacy,
      where the treatment product will be dispensed and used under the supervision of a suitably
      trained study site personnel. Prior to each treatment visit, there will be a washout period
      of a minimum of 3 days. During this period participants will use their own dentifrice for at
      least one day, and a fluoride free dentifrice (provided) for two days prior to the next
      scheduled visit (including in the morning of the scheduled visit) to minimize any carry-over
      effects of the fluoride toothpaste.
    

Intervention name(s): 0.254% w/w sodium fluoride and 5% KNO3; 0.454% w/w stannous fluoride; 5% KNO3
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dentifrice containing 0.254% w/w sodium fluoride (1150 ppm fluoride) and 5% KNO3; plus 0.25% PVM/MA copolymer and 2.5% sodium lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 millilitres [mL] of tap water for 10 seconds before expectorating again.; Dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again.; Fluoride free placebo dentifrice containing 5% KNO3 (0 ppm fluoride), 0.25% PVM/MA copolymer and 2.5% lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again.
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Tin Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment