title: A Randomized Non-Inferiority Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentin Hypersensitivity.
abstract: OBJECTIVE
  Calcium sodium phosphosilicate (CSPS) is a particulate bioactive material incorporated into oral healthcare products for the treatment of dentin hypersensitivity (DH). This study aimed to determine whether a dentifrice containing 5% CSPS and fluoride as sodium fluoride (NaF; "Test dentifrice") was non-inferior to a dentifrice containing 5% CSPS and fluoride as sodium monofluorophosphate (SMFP; "Comparator dentifrice") in reducing DH after eight weeks' twice-daily brushing.
  
  
  METHODS
  This was a randomized, examiner-blind, parallel-group, non-inferiority study in healthy adults with self-reported and clinically diagnosed DH. After an initial lead-in period, subjects were randomized to either the Test (n = 150) or Comparator dentifrice (n = 154) and instructed to brush twice daily for the next eight weeks. DH was assessed at baseline and following four and eight weeks of dentifrice use by response to a tactile stimulus (tactile threshold) and evaporative (air) stimulus (Schiff sensitivity score and 100 mm visual analog scale [VAS]). The non-inferiority margin was defined as 6 mm on the VAS.
  
  
  RESULTS
  Both dentifrices were associated with statistically significant reductions in DH from baseline after four and eight weeks' use for all efficacy parameters (all p < 0.0001). There were no statistically significant differences between the groups. After eight weeks' use, the between-treatment difference in VAS scores was 2.67 mm (per-protocol analysis) in favor of the Comparator dentifrice; the upper limit of the 95% confidence interval (CI) of the between-treatment difference in VAS scores exceeded the pre-specified non-inferiority margin of 6 mm (upper 95% CI = 7.4). The non-inferiority margin was also exceeded after four weeks. Both dentifrices were generally well tolerated.
  
  
  CONCLUSIONS
  The pre-defined non-inferiority margin of 6 mm was not met, thus it is not possible to conclude from the present analysis that the Test dentifrice is non-inferior to the Comparator. However, for all efficacy measures, a statistically significant reduction in DH was observed for both dentifrice groups. There were no statistically significant differences between dentifrice groups, suggesting that changing the source of fluoride from SMFP to NaF does not affect the overall efficacy of the dentifrice in alleviating DH.
authors.affiliation: GSK Consumer Healthcare, Weybridge, Surrey, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Young
authors.affiliation: GSK Consumer Healthcare, Weybridge, Surrey, UK.
authors.forename: Farzana
authors.initials: F
authors.lastname: Sufi
authors.affiliation: InVentiv Health, Maidenhead, Bershire, UK.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Siddiqi
authors.affiliation: Intertek Clinical Research Service Ltd., Hooton, Cheshire, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Maclure
authors.affiliation: Intertek Clinical Research Service Ltd., Hooton, Cheshire, UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Holt
mesh_terms: D000328:Adult; D000388:Air; D003802:Dentifrices / Q000627:therapeutic use*; D057133:Dentin Desensitizing Agents; D003807:Dentin Sensitivity / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005459:Fluorides; D006801:Humans; D008297:Male; D010710:Phosphates; D057566:Self Report; D016037:Single-Blind Method; D012969:Sodium Fluoride / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D003802:Dentifrices; D057133:Dentin Desensitizing Agents; D010710:Phosphates; D012969:Sodium Fluoride; D005459:Fluorides
keywords: calcium sodium phosphosilicate; dentifrice; dentin hypersensitivity; non-inferiority