A long term clinical study evaluating the effect of two dentifrices on oral tissues

1. A long term (54 months) supervised, double-blind human clinical study has been conducted to ascertain whether the routine use of a commercially available cosmetic dentifrice, with purported stain removal and flavor impact characteristics, would cause adverse manifestations in the oral tissues, as compared to the similar use of a more conventional type of commercially available dentifrice. 2. One hundred and twenty male and female subjects (aged 12 to 70) were randomly assigned to the use of one of the two dentifrices under investigation, after which they used the assigned dentifrices twice daily (1 min each brushing) under supervised conditions for a period of 54 months. 3. Clinical examinations were conducted on all subjects initially (base line), and at 3-month intervals throughout the 54-month course of the study. This examination included a complete and thorough inspection of the oral soft and hard tissues. 4. The results after 54 months of continuous use of the dentifrices (representing a total dentifrice/oral tissues exposure time of approximately 45 hours per subject) indicated that neither of the two dentifrices caused any adverse reactions of the oral soft tissues and that both dentifrice groups had similar patterns and levels of cervical abrasion and/or erosion. 5. The results also indicate a lack of direct correlation between laboratory abrasivity values (as determined by a radioactive dentin abrasion procedure) and the clinical situation, thus suggesting that factors other than dentifrice abrasivity may play an important role with regard to tooth wear.