Clinical study to compare extrinsic stain formation in subjects using three dentifrice formulations.
The purpose of this study was to compare the degree of extrinsic dental stain formed with the use of three dentifrices: (1) a new dentifrice formulation containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength Toothpaste, Colgate-Palmolive Co.); (2) a commercially available dentifrice containing 5.0% potassium nitrate and 0.243% sodium fluoride in a silica base (Sensodyne Fresh Mint Toothpaste, Block Drug Company, Inc.); and (3) a dentifrice containing 0.243% sodium fluoride in a silica base (Colgate Winterfresh Gel, Colgate-Palmolive Co.). A total of 121 participants were entered into the study and stratified into 3 balanced groups according to baseline mean Lobene Stain Index scores. A thorough dental prophylaxis was completed on each participant after completion of the baseline examination. The three groups were randomly assigned to use one of the three dentifrices. The groups were well balanced with regard to mean baseline stain index scores, gender, and tobacco habits. Participants were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Extrinsic dental stain examinations, which measured dental stain area and dental stain intensity, were conducted at baseline and 4 and 8 weeks. Examinations were conducted by the same dental examiner at each examination. After 4 and 8 weeks' use of the test dentifrices, there was no statistically significant difference regarding extrinsic stain formation with the use of any of the dentifrices. Thus, it can be concluded from this study that the use of a new formulation dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base will not result in a greater formation of extrinsic dental staining than that which is formed by two commercially available dentifrices not known to cause extrinsic dental stain.
Conforti
N
N
Dental Products Testing, Inc., Lake Worth, Florida, USA.
Mankodi
S
S
Zhang
Y P
YP
Chaknis
P
P
Petrone
M E
ME
DeVizio
W
W
Volpe
A R
AR
D000293:Adolescent; D000328:Adult; D000368:Aged; D000388:Air; D000704:Analysis of Variance; D045424:Complex Mixtures; D003802:Dentifrices / Q000009:adverse effects*; D003807:Dentin Sensitivity / Q000188:drug therapy; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005459:Fluorides / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009566:Nitrates / Q000009:adverse effects; D010710:Phosphates / Q000009:adverse effects; D017680:Potassium Compounds / Q000009:adverse effects; D012822:Silicon Dioxide; D012969:Sodium Fluoride; D014002:Tin Fluorides / Q000009:adverse effects; D014075:Tooth Discoloration / Q000139:chemically induced*; D014110:Touch
C408633:Colgate Winterfresh Fluoride Gel; D045424:Complex Mixtures; D003802:Dentifrices; D004338:Drug Combinations; D009566:Nitrates; D010710:Phosphates; D017680:Potassium Compounds; C097427:Sensodyne; D014002:Tin Fluorides; C444700:colgate sensitive; D012822:Silicon Dioxide; D012969:Sodium Fluoride; D005459:Fluorides