1. A Randomized Clinical Trial Evaluating a 2-step Stannous Fluoride Dentifrice and Whitening Gel System Versus a Potassium Nitrate Dentifrice for Sensitivity Relief

A Randomized Clinical Trial Evaluating a 2-step Stannous Fluoride Dentifrice and Whitening Gel System Versus a Potassium Nitrate Dentifrice for Sensitivity Relief

Reference: Gerlach RW, Underwood J, Miner M. Data on file, 2016.

KEY CLINICAL RESULTS

  • A 2-step stannous fluoride dentifrice and whitening gel system (Crest® PROHEALTH [HD], CPH-HD) provided superior tactile and thermal sensitivity relief (P<0.05) versus a positive control potassium nitrate dentifrice (Sensodyne® Extra Whitening). Both groups provided a significant benefit relative to baseline for both measures (P<0.0001). See Figures 1 & 2.
  • Seventy-two percent (72%) of teeth tested in the CPH-HD group experienced an improvement in thermal sensitivity compared to 53% in the positive control group. Fifty-five percent of teeth tested using the CPH-HD product experienced relief from tactile sensitivity compared to 37% for the positive control.

Figure 1. Mean thermal sensitivity scores at Baseline and Week 2. N=69

Mean thermal sensitivity scores at Baseline and Week 2. N=69

Figure 2. Mean tactile sensitivity scores at Baseline and Week 2. N=69

Mean tactile sensitivity scores at Baseline and Week 2. N=69

OBJECTIVE

To evaluate changes in dentinal hypersensitivity in response to using a two-step stannous fluoride dentifrice and whitening gel system relative to a positive control potassium nitrate sensitivity toothpaste.

  • This was a randomized, controlled, double-blinded study to assess changes in dentinal hypersensitivity over a 2 week period.
  • 71 healthy adult volunteers with current dentinal hypersensitivity were enrolled and randomized to one of the groups for twice a day oral hygiene:
  •  

    - Crest® PRO-HEALTH [HD]: Step 1 is a 0.454% stannous fluoride dentifrice; Step 2 is a 3% is a hydrogen peroxide whitening gel (Procter & Gamble)

    - Positive Control: Sensodyne Extra Whitening with sodium fluoride and 5% potassium nitrate (GlaxoSmithKline)

    - Both groups used a soft, manual toothbrush (Oral-B® Indicator®, Procter & Gamble)

     

  • Assessment of dentinal hypersensitivity was made at baseline (before any treatment) and after 2 weeks of using the randomly assigned treatment using the Schiff Air Index1 (thermal) and Yeaple Probe2 (tactile).
  • Safety was assessed from clinical examination.

CLINICAL COMMENT

Dentinal hypersensitivity is defined as a brief, sharp pain from the exposure of dentin to thermal, tactile, osmotic, chemical, or evaporative stimuli, which cannot be attributed to any other form of dental defect or disease. Patients commonly manage dentinal hypersensitivity by using a dentifrice containing a desensitizing agent, such as potassium nitrate or stannous fluoride. Potassium nitrate is reported to reduce sensitivity by interfering with the transmission of pain signals. Stannous fluoride has been shown to occlude open dentin tubules, reducing fluid flow in response to stimuli and thereby reducing pain.

Stabilized stannous fluoride dentifrice has been shown to provide superior relief from thermal and tactile dentinal hypersensitivity versus negative and positive controls.3 Consistent with published literature, the 2-step stannous fluoride dentifrice and whitening gel system provided superior sensitivity relief compared to a marketed potassium nitrate whitening dentifrice.* This 2-step system has also been shown to provide gingivitis reductions comparable to chlorhexidine* with significant whitening benefits.4,5 Thus, dental professionals can recommend this system to patients with dentinal hypersensitivity with confidence they will not only experience relief from sensitivity, but also improvements in gingival health and tooth whitening.

* via Step 1 stannous fluoride dentifrice
1 Schiff T, et al. J Clin Dent 1994;5 Spec No: 87-92.
2 Schiff T, et al. J Contemp Dent Pract 2006;May;(7)2:001-008.
3 Walters P. Dentinal Hypersensitivity: A Review. Updated Dec 2014; dentalcare.com CE Course #200.
4 Gerlach RW, et al. J Dent Res 2015;94 (Spec Iss A): Abstract 293.
5 Garcia-Godoy, C et al. J Dent Res 2016; 96 (Spec Iss A): Abstract 92.

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