Effects of a chewable sodium bicarbonate oral composition on plaque and gingivitis.

The purpose of this pilot study was to evaluate the effects of an effervescent sodium bicarbonate based oral composition on plaque and gingivitis. Subjects selected for this study presented at screening with moderate plaque and American Academy of Periodontology (AAP) Type I/II periodontal status. At baseline, subjects were allocated to one of two groups by simple randomization; placebo (n=16) and active (n=16). During the study two subjects withdrew due to non-compliance and one because of a death in the family. Data were collected at baseline, day 14, and day 28. The Plaque Index (PI) of Silness and Loe was used to quantify the amount of supragingival plaque surrounding six selected teeth (3,14,8,19,24,30), and the Gingival Index (GI) of Loe and Silness was used to assess bleeding tendencies and visual appearance on the same six teeth. A soft tissue oral assessment was completed at each visit. Subjects were asked to perform study treatment three times a day, after meals, and continue with normal oral hygiene procedures. Subjects were requested to complete a 28-day diary to assess compliance. Data were analyzed using repeated measures analysis of variance. There were no statistically significant differences between the placebo and the active product groups and no statistical significant interaction between product and location within the mouth or visit for either the plaque or gingival scores. Results reveal the product was safe to oral tissues and was well accepted by subjects.