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Randomized Controlled Trial
. 2019 Aug;17(3):261-267.
doi: 10.1111/idh.12379. Epub 2019 Feb 19.

Randomized in situ clinical trial evaluating erosion protection efficacy of a 0.454% stannous fluoride dentifrice

Nicola X West  1 , Tao He  2 , Nikki Hellin  1 , Nicholas Claydon  1 , Joon Seong  1 , Emma Macdonald  1 , Svetlana Farrell  2 , Rachelle Eusebio  2 , Aneta Wilberg  2
Affiliations
Randomized Controlled Trial

Randomized in situ clinical trial evaluating erosion protection efficacy of a 0.454% stannous fluoride dentifrice

Nicola X West et al. Int J Dent Hyg. 2019 Aug.

Abstract

Objectives: To assess the protective effects of a 0.454% stabilized stannous fluoride dentifrice and a marketed triclosan dentifrice against enamel erosion in a 10-day in situ model.

Methods: This was a double-blind, randomized, 2-treatment, 4-period, crossover in situ trial involving healthy adult participants. Participants were randomized to a treatment sequence involving the following products: a highly bioavailable 0.454% stannous fluoride dentifrice (Procter & Gamble) and a marketed dentifrice control containing 0.24% sodium fluoride and 0.3% triclosan (Colgate-Palmolive). Each study period took place over 10 days. Participants wore an intra-oral appliance retaining two polished human enamel samples for 6 hours per day. Two times per day they swished with the assigned dentifrice slurry and four times per day they swished with 250 mL of orange juice (25 mL per minute) over a 10-minute period. Contact profilometry measurements were made for each sample at baseline and day 10 to determine surface change.

Results: Thirty-six participants were enrolled and 33 completed the study (mean age = 40.5 years). The stannous fluoride dentifrice demonstrated 93.5% less enamel loss than the NaF/triclosan dentifrice (P < 0.001) at Day 10, with median enamel loss of 0.097 µm and 1.495 µm, respectively. Both products were well tolerated.

Conclusion: The stannous fluoride dentifrice demonstrated significantly greater erosion protection efficacy relative to the NaF/triclosan dentifrice in this randomized in situ clinical trial.

Keywords: clinical trial; dental erosion; dentifrice; oral hygiene; stannous fluoride.

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Conflict of interest statement

Professor West, Ms Hellin, Dr Claydon, Dr Seong and Dr Macdonald are all full‐time employees of the University of Bristol Dental School and Hospital, Bristol, UK. Dr He, Dr Farrell, Ms Eusebio and Ms Wilberg are all full‐time employees of The Procter & Gamble Company, Mason, OH, USA.

Figures

Figure 1
Figure 1
Intraoral appliance fitted with two enamel samples
Figure 2
Figure 2
Study design with treatment and acid challenge schedule
Figure 3
Figure 3
Box plot of data showing individual and averaged enamel loss data points for each of the two test dentifrices
Figure 4
Figure 4
Dye deposition on acid etched enamel samples following treatment with toothpaste/saliva slurry. Samples were treated with a toothpaste/saliva slurry (1100 ppm stannous fluoride, 1100 ppm sodium fluoride, 1000 ppm sodium monofluorophosphate or 1400 ppm amine fluoride) and exposed to 2% alizarin Red‐S following rinsing. Dye deposition was evaluated using a 5‐point scale; 0 indicates no dye deposition and 4 indicates complete dye coverage. A low score signifies the presence of a barrier layer preventing dye deposition28
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