title: A Randomized Controlled Clinical Trial to Evaluate Extrinsic Stain Removal of a Whitening Dentifrice.
abstract: OBJECTIVE
  To evaluate the extrinsic stain removal efficacy of a new whitening dentifrice containing sodium hexametaphosphate (SHMP) over a two-week period.
  
  
  METHODS
  This study used a controlled and randomized, examiner-blind, single-center, two-treatment, parallel group design. Subjects with visible extrinsic dental stain on facial surfaces of their anterior teeth, and meeting all study criteria, were entered into the trial. The test group received the whitening dentifrice with sodium fluoride and SHMP and an ADA reference soft manual toothbrush. Subjects in the control group received a dental prophylaxis after the initial examination at Baseline and were instructed to use their usual oral hygiene products at home. Subjects returned at Day 3 and Week 2 for re-evaluation of extrinsic dental stain. Extrinsic stain was measured using the Interproximal Modified Lobene (IML) Stain Index; safety was assessed based on clinical examination.
  
  
  RESULTS
  Fifty subjects (mean age 32.0 years) completed the study, with 25 in each group. Statistically significant reductions in composite stain for whole tooth, as well as interproximal, gingival, and body surfaces were observed for both groups at Day 3 and Week 2 (p < 0.0001) with no significant differences between the two groups (p > 0.3). At Day 3, median percent reductions in composite IML stain from Baseline were 98% for the prophylaxis group and 100% for the test dentifrice group. At Week 2, median percent reductions in composite IML stain were 100% compared to Baseline for both groups. No adverse events were reported for either group.
  
  
  CONCLUSIONS
  The whitening dentifrice demonstrated a statistically significant reduction in IML stain after three days and two weeks of use relative to baseline. Stain reduction with the toothpaste was comparable to a dental prophylaxis.
authors.affiliation: University of Texas Health Science Center at San Antonio San Antonio, TX, USA.
authors.forename: Géza
authors.initials: G
authors.lastname: Terézhalmy
authors.affiliation: Procter & Gamble Health Care Research Center, Mason, OH, USA.
authors.forename: Tao
authors.initials: T
authors.lastname: He
authors.affiliation: Procter & Gamble Health Care Research Center, Mason, OH, USA.
authors.forename: Mary Kay
authors.initials: MK
authors.lastname: Anastasia
authors.affiliation: Procter & Gamble Health Care Research Center, Mason, OH, USA.
authors.forename: Rachelle
authors.initials: R
authors.lastname: Eusebio
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D004396:Coloring Agents; D003802:Dentifrices / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D012822:Silicon Dioxide; D012969:Sodium Fluoride; D014073:Tooth Bleaching; D014075:Tooth Discoloration / Q000628:therapy*; D014100:Toothpastes; D016896:Treatment Outcome
chemical_list: D004396:Coloring Agents; D003802:Dentifrices; D014100:Toothpastes; D012822:Silicon Dioxide; D012969:Sodium Fluoride
keywords: Interproximal Modified Lobene Stain Index; sodium hexametaphosphate; stain removal; whitening dentifrice