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

Abstract

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 (α-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>0.0001) in samples taken 12h after brushing. In study 2, mean plaque and gingival indices were significantly reduced in both test and control group after three weeks compared to baseline; there was no significant difference between the test and control group after three weeks. In study 3, mean plaque and gingival indices were significantly reduced in both test and control group after three and nine weeks compared to baseline; there was no significant difference between the test and control group after three and nine weeks. Conclusion: The delivery of zinc and triclosan from a new oral health toothpaste containing zinc citrate trihydrate and triclosan was unaffected by the addition of α-tocopherol acetate (vitamin E) and sunflower oil (vitamin F). The new toothpaste was effective in reducing plaque levels and improving gingival conditions to the same degree as a clinically proven positive control. Regular oral hygiene with this toothpaste is therefore beneficial for maintaining healthy and strong gums.