1. A Randomized Clinical Trial to Measure the Erosion Protection Benefits of a Stannous Fluoride Dentifrice versus a Triclosan/Copolymer Dentifrice

A Randomized Clinical Trial to Measure the Erosion Protection Benefits of a Stannous Fluoride Dentifrice versus a Triclosan/Copolymer Dentifrice

Reference: N. West, T. He, Hellin N, et al. J Dent Res 2017;96 (Spec Iss A): Abstract 0610

KEY CLINICAL FINDINGS

Crest® PRO-HEALTH™ Advanced dentifrice (SnF2) demonstrated significantly greater protection against dental erosion relative to the Colgate Total (triclosan/copolymer) dentifrice in a 10-day in situ clinical study. At Day 10, the SnF2 dentifrice demonstrated 93.5% lower enamel loss than the triclosan/copolymer dentifrice with median loss of 0.097 μm and 1.495 μm, respectively, which wasstatistically significant (P<0.0001). See Figure. Both products were well tolerated.

Figure. Treatment comparison at Day 10: Median Change in Enamel (μm)

Treatment comparison at Day 10: Median Change in Enamel (μm)

* Treatment difference at Day 10 was statistically significant. P<0.0001 N=34.

OBJECTIVE

To compare the enamel protection efficacy (loss of tooth enamel due to erosion as measured by surfometry) of a marketed stannous fluoride dentifrice and a marketed triclosan/copolymer sodium fluoride dentifrice in a 10-day in situ erosion model.

STUDY DESIGN

  • A single center, double-blind, randomized, 2-treatment, and 4-period crossover clinical study was conducted involving healthy adults.
  • Subjects presented for 4 study periods and were randomized to treatment sequences, receiving one of the two marketed dentifrice products each period:
  1. Crest® PRO-HEALTH Advanced — 0.454% Stannous fluoride (1100 ppm fluoride), The Procter & Gamble Company, Cincinnati, OH.
  2. Colgate® Total® Clean Mint — 0.24% Sodium fluoride with 0.3% Triclosan/ copolymer, Colgate-Palmolive Co., New York, NY.
  • 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 (Crest® Decay Protection, 1450 ppm F as sodium fluoride, Procter & Gamble) and a manual toothbrush (Oral-B® 35, Procter & Gamble) supplied at the screening visit.
  • Subjects then attended the clinical trials unit where they collected their upper palatal intra-oral appliance fitted with two 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 swished twice a day with their assigned treatment toothpaste slurry at the clinical site for 60 seconds.
  • 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 study period.
  • Page 29 of 56