Ninety-two dental and
dental hygiene students completed a double-blind, controlled clinical trial. The purpose of the trial was to evaluate the effects of
toothpastes, in varying concentrations of flavor and
tartar-control agents. Four formulations of
toothpastes were assessed: (A) control-low flavor with no
tartar control; (B) medium flavoring with medium
tartar control; (C) high flavoring with medium
tartar control; and (D) medium flavoring with no
tartar control. Soft tissue reactions were assessed objectively and independently by three examiners. Subjective perceptions about each
toothpaste were gathered by a structured, open-ended questionnaire. The "
tartar control"
toothpastes, B and C, resulted in statistically significant (p less than 0.005) higher rates of mucosal reactions (e.g., ulceration, sloughing,
erythema, migratory
glossitis) than the "non-
tartar control"
toothpastes A and D. When the oral mucosal reaction rates were adjusted for multiple clinical observations within each subject at the same point in time there was no statistically significant (p greater than 0.05) difference between male (0.25) and female (0.28) subjects. In this study population, the order of preference was observed as
toothpaste A greater than D greater than B greater than C. The major reasons for disfavor were burning sensation in
toothpastes C (2.4%) and B (4%).