Effectiveness of a Toothpaste Containing 20% High Cleaning Silica, 1% Sodium Phytate and 2% PVM/MA Copolymer on Removing Extrinsic Tooth Stain

Objectives: To evaluate the effectiveness of a toothpaste containing 20% high cleaning silica, 1% sodium phytate and 2% PVM/MA copolymer on extrinsic tooth stain removal.
Methods: This clinical study used a randomized, double-blinded, placebo-controlled design. A total of 84 adults who met all the study criteria were enrolled and randomly distributed into the test and control groups. Subjects in the test group received the whitening toothpaste containing 20% high cleaning silica, 1% sodium phytate and 2% PVM/MA copolymer. Subjects in the control group received the negative control toothpaste. At baseline, 4 weeks, and 8 weeks, they received an oral hard and soft tissue examination. They also received an evaluation of tooth stain using Lobene stain index on the buccal surfaces of upper anterior teeth, buccal and lingual surfaces of lower anterior teeth. Adverse events were monitored.
Results: Altogether 81 subjects completed the study. There was no withdrawal related to the use of the products. After 8 weeks the mean Lobene area stain score in the test group was lower than that in the control group (0.85±0.35 versus 1.08±0.45; P<0.001), the mean Lobene intensity stain score in the test group was lower than that in the control group (0.95±0.47 versus 1.18±0.49; P<0.001), and the mean Lobene composite stain score in the test group was lower than that in the control group(1.41±0.91 versus 2.02 ±1.06; P<0.001). Compared to the control group, the test group had reductions of 20.84%, 19.41% and 29.97%, respectively, in the mean Lobene area, intensity and composite stain scores (all P<0.001). No adverse events were reported throughout the study.
Conclusions: The toothpaste containing 20% high cleaning silica, 1% sodium phytate and 2% PVM/MA copolymer was efficacious in removing extrinsic tooth stain after 8 weeks of use in comparison with a negative control toothpaste.