title: The Featherstone laboratory pH cycling model: a prospective, multi-site validation exercise.
abstract: OBJECTIVE
  To demonstrate the robustness of the Featherstone pH cycling model when tested in three independent laboratories and to evaluate the use of "non-inferiority" testing at those laboratories.
  
  
  METHODS
  The fundamental principles for the Featherstone laboratory pH cycling model to be an appropriate alternative to animal testing is that it must demonstrate equivalent accuracy to the "Gold Standard" (rat caries model) by: (1) providing a meaningful representation of the caries process; (2) demonstrating a proportionate response to fluoride dose (or concentration); (3) being able to show that clinically proven formulations perform similarly relative to the controls; and (4) differentiating products that have attenuated fluoride activity.
  
  
  RESULTS
  This cross-validation study confirmed the ability of the three independent laboratories to discriminate between various concentrations of fluoride-containing dentifrice formulations, demonstrated that clinically proven formulas perform as expected and identified an attenuated fluoride formulation (NaF/CaCO3 dentifrice - 1100 ppm NaF) as inferior compared to the 1100 ppm F (NaF/silica) positive control.
authors.affiliation: Therametric Technologies, Inc., 9880 Douglas Floyd Parkway, Noblesville, IN 46060, USA. gstookey@therametric.com
authors.forename: George K
authors.initials: GK
authors.lastname: Stookey
authors.forename: John D B
authors.initials: JD
authors.lastname: Featherstone
authors.forename: Marcia
authors.initials: M
authors.lastname: Rapozo-Hilo
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Schemehorn
authors.forename: Ross A
authors.initials: RA
authors.lastname: Williams
authors.forename: Robert A
authors.initials: RA
authors.lastname: Baker
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Barker
authors.forename: Michael A
authors.initials: MA
authors.lastname: Kaminski
authors.forename: Christine M
authors.initials: CM
authors.lastname: McQueen
authors.forename: Jack S
authors.initials: JS
authors.lastname: Amburgey
authors.forename: Keith
authors.initials: K
authors.lastname: Casey
authors.forename: Robert V
authors.initials: RV
authors.lastname: Faller
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D002327:Cariostatic Agents / Q000627:therapeutic use*; D002417:Cattle; D003731:Dental Caries / Q000503:physiopathology / Q000517:prevention & control; D003743:Dental Enamel; D003802:Dentifrices / Q000737:chemistry* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005459:Fluorides / Q000627:therapeutic use*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D011446:Prospective Studies; D015203:Reproducibility of Results
chemical_list: D002327:Cariostatic Agents; D003802:Dentifrices; D005459:Fluorides