1. A Randomized Clinical Trial to Measure the Erosion Protection Benefits of a Stabilized Stannous Fluoride Dentifrice versus a Control Dentifrice

A Randomized Clinical Trial to Measure the Erosion Protection Benefits of a Stabilized Stannous Fluoride Dentifrice versus a Control Dentifrice

Reference: XY Zhao1, T He2, Y He2, C Cheng2, HJ Chen2.

1Fourth Military Medical University, Xi’an, PR China; 2Procter & Gamble.

KEY CLINICAL RESULTS

The experimental stabilized stannous fluoride (SnF2) dentifrice provided 26.9% greater erosion protection relative to the control dentifrice at Day 10 (P<0.03).

Figure 1. Enamel loss at Day 10

Enamel loss at Day 10

*Lussi A. Int Dent J 2014; 64 (Suppl 1): 2-3.

OBJECTIVE

To compare the enamel protection efficacy of a stabilized stannous fluoride dentifrice and a marketed control dentifrice in a 10-day in situ erosion model.

STUDY DESIGN

  • A single center, double-blind, randomized, 2-treatment, and 3-period crossover clinical study was conducted involving healthy adults.
  • Subjects presented for 3 study periods and were randomized to treatment sequences, receiving one of the two marketed dentifrice products each period:
  1. Experimental 0.454% stabilized SnF2 dentifrice (Crest® PRO-HEALTH Clean Mint [Smooth Formula], Procter & Gamble)
  2. Sodium fluoride dentifrice with potassium nitrate marketed for protection from the effects of acid erosion (Sensodyne® Pronamel®, GlaxoSmithKline)
  • Each study period was comprised of 10 treatment days. On each treatment day, subjects brushed their teeth at home in their usual manner, using a non-treatment toothpaste and a regular, soft manual toothbrush supplied at the screening visit.
  • Subjects then attended the clinical trials unit where they collected their lower palatal intraoral appliance fitted with 8 enamel samples and placed it in their mouth. Subjects wore the appliance for approximately 6 hours total over the course of each study day. While wearing the appliance, subjects brushed their lingual teeth for 30 seconds, and swished with their assigned treatment toothpaste slurry for 90 seconds twice a day under the supervision of clinic staff.
  • The erosive challenge occurred with the appliance in the mouth. The subjects were required to sip 25mL of orange juice over a timed minute, swishing it around their mouth, then spitting out. This was repeated 10 times so that a total of 250mL of orange juice was exposed to the enamel samples over a 10 minute period. The erosive challenge occurred a total of four times on each treatment day.
  • On Day 10, the enamel samples were measured for tissue loss using a calibrated contact surface profilometer. Measurements were taken at baseline, prior to the start of the study, and at the end of treatment Day 10. Fresh enamel samples were placed in the intra-oral appliance at the beginning of each treatment period.
  • Statistical analyses utilized a general linear mixed model with period and treatment as fixed effects and subject as a random effect.

CLINICAL COMMENT

Stabilized SnF2 dentifrice has been shown to provide significantly greater protection from acid erosion compared to other types of fluoride dentifrice.* In this trial, a novel stabilized stannous fluoride dentifrice showed a significant anti-erosion benefit over a sodium fluoride/potassium nitrate dentifrice which is marketed for protecting enamel against acid erosion. Dental professionals should consider recommending this SnF2 dentifrice for its high level of protection against acid erosion as well as its benefits for reduction of gingivitis and plaque.

*Lussi A. Int Dent J 2014; 64 (Suppl 1): 2-3.

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