In situ efficacy of an experimental toothpaste on enamel rehardening and prevention of demineralisation: a randomised, controlled trial

Jonathan E Creeth, Gary R Burnett, Audrey Souverain, Paola Gomez-Pereira, Domenick T Zero, Frank Lippert, Anderson T Hara, Jonathan E Creeth, Gary R Burnett, Audrey Souverain, Paola Gomez-Pereira, Domenick T Zero, Frank Lippert, Anderson T Hara

Abstract

Background: A novel sodium fluoride toothpaste containing lactate ion and polyvinylmethylether-maleic anhydride has been developed to promote enamel remineralisation and resistance to demineralisation. In this in situ study, we compared this toothpaste ('Test') with a stannous fluoride-zinc citrate (SnF2-Zn) toothpaste ('Reference') (both 1100-1150 ppm fluoride) and a fluoride-free toothpaste ('Placebo') using an enamel dental erosion-rehardening model.

Methods: In each phase of this randomised, investigator-blind, crossover study, participants wore palatal appliances holding bovine enamel specimens with erosive lesions. They brushed their natural teeth with either the Test, Reference or Placebo toothpastes, then swished the resultant slurry. Specimens were removed at 2 h and 4 h post-brushing and exposed to an in vitro acid challenge. Surface microhardness was measured at each stage; enamel fluoride uptake was measured after in situ rehardening. Surface microhardness recovery, relative erosion resistance, enamel fluoride uptake and acid resistance ratio were calculated at both timepoints.

Results: Sixty two randomised participants completed the study. Test toothpaste treatment yielded significantly greater surface microhardness recovery, relative erosion resistance and enamel fluoride uptake values than either Reference or Placebo toothpastes after 2 and 4 h. The acid resistance ratio value for Test toothpaste was significantly greater than either of the other treatments after 2 h; after 4 h, it was significantly greater versus Placebo only. No treatment-related adverse events were reported.

Conclusions: In this in situ model, the novel-formulation sodium fluoride toothpaste enhanced enamel rehardening and overall protection against demineralisation compared with a fluoride-free toothpaste and a marketed SnF2-Zn toothpaste.

Trial registration: ClinicalTrials.gov; NCT03296072; registered September 28, 2017.

Keywords: Clinical study; Dentifrice; Erosion; Sodium fluoride.

Conflict of interest statement

This study was funded by GSK Consumer Healthcare, of whom JEC, GRB, AS, and PGP are employees. ATH, DTZ and FL are full-time faculty at the Indiana University School of Dentistry, Oral Health Research Institute, which has received funding from GSK Consumer Healthcare. FL and DTZ have received compensation from GSK Consumer Healthcare as consultants in the past.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Raw mean (±SE) percent surface microhardness recovery (%SMHR) by treatment group (mITT population). Higher values are favourable
Fig. 3
Fig. 3
Raw mean (±SE) percent relative erosion resistance (%RER) by treatment group (mITT population). Higher (less negative) values are favourable
Fig. 4
Fig. 4
Raw mean (±SE) enamel fluoride uptake (EFU) by treatment group (mITT population). Higher values are favourable
Fig. 5
Fig. 5
Raw mean (±SE) acid resistance ratio (ARR) by treatment group (mITT population). Higher values are favourable

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