Forty healthy adult volunteers from the Junior Comprehensive Care Clinics a
t New York University College of Dentistry were accepted as subjects for th
is three-month, examiner-blinded, parallel-group clinical trial. To be elig
ible for a baseline clinical examination, subjects had to first indicate th
at during the previous six months they habitually brushed their teeth two o
r more times per day and had noticed "bleeding gums" or "blood in the tooth
paste" after brushing or after flossing their teeth. At the baseline examin
ation, subjects were enrolled in the study if they were found to have at le
ast five Loe-Silness gingival bleeding sites and 20 natural teeth, includin
g four molars. Subjects were assigned to one of the two following treatment
groups: 1) Herbal Mouth and Gum Therapy(R); or 2) Control (distilled water
and dye). Subjects were instructed to clean their teeth in their usual man
ner, not to use any other mouthrinses or oral irrigation products for the d
uration of the study. Subjects were to return for clinical examinations aft
er three months of product use. At these examinations, gingivitis and gingi
val bleeding scores were recorded. An independent t-test before treatment i
ndicated that there were no significant differences between the baseline ev
aluations of the two groups in the study. A one-way analysis of variance (A
NOVA), comparing gingivitis and bleeding scores from baseline and three mon
ths with the baseline scores as a covariate, indicated that Herbal Mouth an
d Gum Therapy produced a statistically significant effect (p < 0.01) on bot
h parameters relative to the control mouthrinse. The results of this study
support the clinical efficacy of Herbal Mouth and Gum Therapy in reducing g
ingivitis and gingival bleeding.