Eight-week Stain Removal Clinical Study by Two Toothbrush Products

Objectives:This eight week, single-blind, clinical trial was to determine the efficacy of two toothbrush products, the powered Ultrasonex^TM (U) (Salton Inc, USA) vs Oral-B P35^TM (OB) (Oral-B Labs, USA) on natural extrinsic tooth stain removal. Methods:After IRB approval,a medical history was taken, inclusion/exclusion criteria were met, and subjects signed a consent form. Stain was then recorded (modified Lobene index). Subjects were stratified according to initial stain scores,balanced on smoking, and randomly assigned to one of the two toothbrushes. All subjects were instructed to brush twice daily according to product label instructions and with a fluoride dentifrice provided by the sponsor. At four and eight weeks, the subjects were recalled for both safety and extrinsic stain levels. Changes from baseline were assessed with the anova for repeated measures. Results: Of 101 subjects starting the study, 99 finished. At baseline, there were no significant differences between the group means (U=1.46(.84), OB=1.50(.89)). At four-weeks, there was a difference on stain extent (p<.05:U=1.18(.69),OB=1.44(.76)) and total stain (p<.01:U=1.29(.83),OB=1.55(.87)) At eight-weeks, there was a significant difference on Stain Severity (p<.05:U=1.32(.98),OB=1.72(.93)), Stain Extent (p< 0.01:U=1.09(.73),OB=1.50(.74)),and Total Stain (p<.001:U=1.20(.87),OB=1.61(.84)). Only the U Group had a significant statistical reduction in Stain Extent and Total Stain from baseline to eight-weeks (p<.05). In the OB group all Stain indicies increased from baseline to four weeks and again at eight weeks. No unusual hard or soft findings were noted by the investigators, or subjects, at anytime during this study. Conclusions:The powered toothbrush was found to be an effective product for extrinsic stain reduction with regular use. Grant from Salton Inc.