A nine-week, double blind clinical trial was conducted to evaluate the effectiveness of a novel
tartar control whitening
dentifrice with a
silica-based abrasive system on induced dental
stain. The study model involved three weeks of
stain induction followed by six weeks of unsupervised brushing to assess efficacy. To induce
stain, 222 healthy adult volunteers received a
dental prophylaxis, and then began a limited brushing regimen supplemented by three-times daily rinsing with
tea and once daily rinsing with 15 ml of 0.12%
chlorhexidine. This regimen was suspended, and 187 subjects with tooth
stain were entered into a six-week clinical trial where they were randomized to either a
silica-based
tartar control whitening
dentifrice or a marketed regular
dentifrice control, balancing for
stain levels and smoking status. At baseline, three and six weeks,
stain area and
stain intensity were measured on the 8 anterior teeth using the Lobene Index. After six weeks' use, composite Lobene means were 35% lower for the whitening
dentifrice compared to the regular control. In addition to the overall reductions, there were statistically significant reductions in
stain area (p < 0.015) and
stain intensity (p < 0.01) at both three and six weeks. The
tartar control whitening
dentifrice was effective in removing
stain on the gingival margins and elsewhere on the body of the tooth. Safety profiles for the two test
dentifrices were generally similar. After three and six weeks' use, the
tartar control whitening
dentifrice reduced
chlorhexidine and
tea stain compared to the marketed control.