Evaluation of different fluoridated dentifrice formulations using an in situ erosion remineralization model.
OBJECTIVE
The objective of these three clinical in situ studies was to investigate the relative performance of commercially available and experimental dentifrice formulations, having different fluoride sources and excipient ingredients, at remineralizing a bovine enamel surface previously softened by a dietary acid challenge.


METHODS
Each study utilized the same randomized, placebo-controlled, single-blind, crossover design. Subjects undertook single brushings of their natural teeth, with an in situ appliance in place, using different dentifrices in a randomly assigned order. Study A involved 58 subjects with the following dentifrices: Sensodyne Pronamel (1450 ppm F as NaF/5% KNO3); Blend-a-Med Classic (1450 ppm F as NaF); and a matched (Pronamel) placebo control (0 ppm F). Study B involved 56 subjects with the following dentifrices: Sensodyne Pronamel (1150 ppm F as NaF/5% KNO3); Crest Cavity Protection (1100 ppm F as NaF); Crest Pro-Health (0.454% SnF2 [1100 ppm F]/sodium hexametaphosphate); and a matched (Pronamel) placebo control (0 ppm F). Study C involved 56 subjects with the following dentifrices: Sensodyne Pronamel (1150 ppm F as NaF/5% KNO3); Sensodyne Pronamel Gentle Whitening (1150 ppm F as NaF/5% KNO3); Colgate Sensitive Multi Protection (1000 ppm F as NaMFP/5.53% potassium citrate/2% zinc citrate); and a matched (Pronamel) placebo control (0 ppm F). Subjects wore their palatal appliances holding eight bovine enamel blocks, previously exposed for 25 minutes to an in vitro erosive challenge with grapefruit juice, for the duration of the experiment. Five minutes after appliance insertion, subjects undertook a supervised, 90-second brush/rinse regimen with their assigned dentifrice. Surface microhardness (SMH) of the specimens was determined prior to the erosive challenge (baseline), after the in vitro erosive challenge, and were remeasured after four hours in situ remineralization following the tooth brushing event. Finally, SMH values were determined after a second in vitro erosive challenge at the end of the in situ remineralization period. Statistical analyses included ANOVA and pair-wise comparisons between treatments, testing at a 5% significance level.


RESULTS
All three studies demonstrated significantly greater percent surface microhardness recovery (% SMHr) and percent relative erosion resistance (% RER) for dentifrices containing sodium fluoride compared to placebo controls. Overall, significantly greater % SMHr (p < 0.0001) was observed for Sensodyne Pronamel compared to Blend-a-Med Classic, Crest Pro-Health, and Colgate Sensitive Multi Protection dentifrices. Similarly, Sensodyne Pronamel delivered directionally better % RER vs. Blend-a-Med Classic (p = 0.0731), and significantly higher % RER vs. Crest Pro-Health (p = 0.0074) and Colgate Sensitive Multi Protection (p <0.0001). Crest Cavity Protection demonstrated significantly better % RER (p = 0.031) than Crest Pro-Health, which in turn demonstrated significantly better % RER than the placebo control (p < 0.0001). No other statistically significant between-product comparisons were observed.


CONCLUSIONS
The results of these in situ studies support the effectiveness of dentifrices containing sodium fluoride to reharden enamel previously softened with an erosive challenge. Furthermore, these studies demonstrate the protective effects conferred to enamel, from erosion following the remineralization process in the presence of "ionic" fluoride. Under clinically relevant conditions, Sensodyne Pronamel and Sensodyne Pronamel Gentle Whitening offered superior anti-erosion performance compared to currently marketed dentifrice controls. These studies reinforce previous research indicating the importance of formulation effects on the relative remineralization performance of dentifrices under erosive conditions.
GlaxoSmithKline Consumer Healthcare Weybridge, Surrey, UK. Ashley.P.Barlow@gsk.com
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Barlow
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Sufi
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Mason
D000328:Adult; D017607:Aluminum Compounds; D000818:Animals; D017610:Calcium Compounds; D002417:Cattle; D019343:Citric Acid / Q000009:adverse effects; D018592:Cross-Over Studies; D003743:Dental Enamel / Q000473:pathology*; D003802:Dentifrices / Q000737:chemistry / Q000627:therapeutic use*; D005260:Female; D005459:Fluorides / Q000627:therapeutic use; D006244:Hardness; D006801:Humans; D008297:Male; D010710:Phosphates / Q000627:therapeutic use; D016037:Single-Blind Method; D012969:Sodium Fluoride / Q000627:therapeutic use*; D013499:Surface Properties; D014077:Tooth Erosion / Q000139:chemically induced / Q000188:drug therapy*; D014089:Tooth Remineralization / Q000379:methods*
D017607:Aluminum Compounds; D017610:Calcium Compounds; D003802:Dentifrices; D010710:Phosphates; C035219:calcium aluminate; C012980:fluorophosphate; D019343:Citric Acid; D012969:Sodium Fluoride; C009285:sodium polymetaphosphate; D005459:Fluorides