1. A Clinical Trial Evaluating Immediate Sensitivity Relief of a 0.454% Stannous Fluoride Dentifrice

A Clinical Trial Evaluating Immediate Sensitivity Relief of a 0.454% Stannous Fluoride Dentifrice

Reference: He, ML Barker, Qaqish J, et al. J Clin Dent 2011; 22: 46-50.

KEY CLINICAL RESULTS

  • The stannous fluoride (SnF2) dentifrice provided superior sensitivity protection relative to the negative control immediately after the first use based on the Thermal Schiff Index (13.8%, P<0.0001) and the Thermal Air Visual Analog Scale (14.6%, P<0.0001). See Figures 1 & 2.
  • The SnF2 dentifrice also provided superior (P<0.0001) relief relative to the negative control at Day 3 and at Week 2 based on the Thermal Schiff Air Index (31.8% and 61.3%, respectively), the Thermal Air Visual Analog Scale (34.8% and 66.6%, respectively) and the Tactile Yeaple Probe (186% and 239%, respectively). See Figures 1 & 2 and Table 1.
  • The test products were well tolerated.

Figure 1. Thermal Schiff Air Index Adjusted Mean Scores
(Lower score indicates less sensitivity)

Thermal Schiff Air Index Adjusted Mean Scores

Figure 2. Thermal Air Visual Analog Scale Adjusted Mean Scores
(Lower score indicates less sensitivity)

Thermal Air Visual Analog Scale Adjusted Mean Scores

Table 1. Tactile Yeaple Probe Mean Scores
(Higher score indicates less sensitivity)

Tactile Yeaple Probe Mean Scores

OBJECTIVE

To evaluate the efficacy of a SnF2 dentifrice in the reduction of dentinal hypersensitivity after immediate use, 3 days and 2 weeks of use as compared to a negative control dentifrice.

STUDY DESIGN

  • This was a controlled, randomized, examiner-blind, two-treatment, parallel group clinical trial.
  • One hundred eleven healthy adult subjects with moderate dentinal hypersensitivity were enrolled and randomized to one of two treatment groups.
  • Crest® PRO-HEALTH Advanced — 0.454% Stannous fluoride (1100 ppm fluoride), The Procter & Gamble Company, Cincinnati, OH.
  • At the Baseline visit, subjects received an oral soft tissue (OST) exam to evaluate the overall health of the mouth and then were reassessed for tooth sensitivity. Subjects with at least two sensitive teethdemonstrating reproducible sensitivity to both thermal and tactile stimuli and who met all eligibility criteria were enrolled in the study. For those subjects who had greater than two teeth meeting the eligibility criteria, only two were selected for enrollment in the study.
  • Subjects were then randomized to treatment (either Crest® PRO-HEALTH Sensitive Shield with 0.454% stannous fluoride, The Procter & Gamble Company or Colgate Cavity Protection dentifrice with 0.76% Sodium monofluorophosphate, Colgate-Palmolive). Products and treatment kits were identical in appearance to preserve blinding.
  • Subjects were instructed, according to manufacturer’s usage instructions, to brush with their assigned dentifrice thoroughly twice a day (morning and evening). Subjects in the stannous fluoride dentifrice group brushed the sensitive teeth first.
  • Subjects performed their first product use on site under the supervision of site staff. Immediately (within 5 minutes) following the first treatment, both the examiner and subjects re-assessed thermal sensitivity for each enrolled tooth using the Schiff Air Index (assessed by examiner) and Thermal Air Visual Analog Scale (assessed by subjects).
  • Safety and efficacy measurements, using Schiff Air Index, Thermal Air Visual Analog Scale and Tactile Yeaple Probe, were re-assessed at the Day 3 and Week 2 study visits.
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