Extrinsic tooth stain removal efficacy of a sodium bicarbonate dual-phase dentifrice containing calcium and phosphate in a six-week clinical trial.
OBJECTIVE
The objective of this clinical investigation was to evaluate the effectiveness in removing existing extrinsic tooth stains of a sodium bicarbonate (baking soda), dual-phase dentifrice containing calcium and phosphate (Test Dentifrice), when compared to a commercial hydrated silica dentifrice (Control Dentifrice), during a six-week period of normal, unsupervised use.


METHODS
This investigation was a double-blind comparison of two equivalent, parallel groups of subjects assigned to use different dentifrices for six weeks. A total of 108 adult male and female subjects qualified for the trial based on the presence of existing extrinsic tooth stains and other inclusion/exclusion criteria. The two groups were balanced for gender, tobacco use, and extrinsic tooth stain scores, and randomly assigned the Test or Control dentifrices. All subjects were instructed to brush their teeth twice daily using only the dentifrice and toothbrush provided, and to refrain from using any other oral hygiene products for the duration of the study. Although product usage was unsupervised after the baseline visit, subjects maintained a treatment diary, and product consumption was monitored to estimate compliance. Oral soft and hard tissue and extrinsic stain assessments (Modified Lobene Stain Index) for each subject were conducted at baseline and after two, four, and six weeks of product use.


RESULTS
A total of 107 subjects complied with the protocol and completed the six-week study. Compared to baseline, at the two-, four-, and six-week examinations the Test Dentifrice group had statistically significant reductions in extrinsic tooth stain. In contrast, the Control Dentifrice group did not attain significant reductions from baseline at any of the exams. At both the four-week and six-week examinations, the Test Dentifrice group had significantly lower levels of extrinsic tooth stain than the Control Dentifrice group.


CONCLUSIONS
A sodium bicarbonate, dual-phase dentifrice containing calcium and phosphate demonstrated statisically significant efficacy in removing naturally acquired, extrinsic tooth stain, and was significantly more effective for stain removal than a commercially available, hydrated silica dentifrice.
Putt
Mark S
MS
University Park Research Center, Fort Wayne, IN, USA. putt@ipfw.edu
Milleman
Jeffery L
JL
Ghassemi
Annahita
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002118:Calcium / Q000008:administration & dosage / Q000627:therapeutic use*; D003802:Dentifrices / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006861:Hydrogen Peroxide; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000008:administration & dosage / Q000627:therapeutic use*; D012824:Silicic Acid; D012822:Silicon Dioxide / Q000008:administration & dosage / Q000627:therapeutic use; D012907:Smoking; D017693:Sodium Bicarbonate / Q000008:administration & dosage / Q000627:therapeutic use*; D012969:Sodium Fluoride / Q000008:administration & dosage / Q000627:therapeutic use; D014075:Tooth Discoloration / Q000145:classification / Q000628:therapy*; D014100:Toothpastes / Q000008:administration & dosage / Q000627:therapeutic use
D003802:Dentifrices; D010710:Phosphates; D014100:Toothpastes; C546060:hydrated silica gel-based toothpaste; C546054:sodium bicarbonate-based toothpaste; D012824:Silicic Acid; D012822:Silicon Dioxide; D017693:Sodium Bicarbonate; D012969:Sodium Fluoride; D006861:Hydrogen Peroxide; D002118:Calcium