In vivo evaluation of an oral health toothpaste with 0.1% vitamin E acetate and 0.5% sunflower oil (with vitamin F)

Objectives: To measure the delivery of active ingredients of a new oral health toothpaste with zinc citrate trihydrate/triclosan and containing α-tocopherol acetate (vitamin E) and sunflower oil (vitamin F) and compare its anti-plaque / anti-ginigvitis efficacy to that of a clinically proven control toothpaste. Methods: The new toothpaste contained 0.1% vitamin E acetate (a-tocopherol acetate) and 0.5% sunflower oil as a source for vitamin F (linoleic acid). It also included an anti-caries agent (0.32% sodium fluoride) and a proven gum-health active system (0.3% triclosan and 0.75% zinc citrate trihydrate). Three studies were carried out. In study 1 (n=45) the bio-availability of zinc and triclosan was measured in plaque 12h after brushing with the test toothpaste. In study 2 (n=93) the effect of the test toothpaste on plaque and gingival condition was investigated over three weeks in a randomised, parallel, double-blind, controlled design. The control toothpaste was a fluoride toothpaste containing 0.3% triclosan. Healthy adult volunteers with GI>1.0 were enrolled and given a full mouth scale and polish. Plaque levels (Modified Quigley and Hein Index) and gingival condition (Gingival Index) were assessed at baseline and after three weeks. Study 3 (n=93) lasted for nine weeks. Subjects did not receive a full mouth scale and polish at baseline but the study was otherwise identical to study 2. Results: In study 1, no triclosan was detected in baseline plaque samples; mean triclosan concentration in plaque 12h after last brushing with the test toothpaste was 5.78μg/g (std=4.74); the mean zinc concentration rose from 15.2μg/g zinc ion in baseline plaque samples to 84.3μg/g zinc ion (p