The purpose of this six-week clinical study was to determine the effic
acy of sugar-free chewing gum versus no chewing on preventing Peridex(
R) (0.12% chlorhexidine)-associated stain. One-hundred and fifty healt
hy adult subjects, categorized by tea or coffer intake and smoking, we
re randomly assigned to a chewing or no chewing gum group. All subject
s were given Peridex and an ADA-approved toothbrush and fluoride tooth
paste to use twice a day. Gum was chewed for 20 minutes five times eac
h day, after toothbrushing and Peridex rinse in the morning and evenin
g, and after each meal. At baseline, all subjects received a professio
nal cleaning to remove all supragingival deposits and extrinsic stain.
At three and six weeks, safety and stain intensity and area were moni
tored on the anterior teeth and posterior Ramfjord teeth using the Lob
ene stain scoring method. Seventy-two subjects in each group completed
the study. Attrition was unrelated to product use. No untoward reacti
ons were reported or observed at any time in the study. Ar the six-wee
k evaluations, the chewing gum group exhibited significantly lower (p
< 0.05-0.001) total stain scores on both anterior and posterior areas
evaluated compared to the no chewing group scores. In addition to the
stain evaluations, a randomly selected subset of 60 subjects was evalu
ated for gingivitis at baseline prior to cleaning, and at three and si
x weeks, on the buccal and lingual surfaces of the Ramfjord teeth. Bot
h the chewing gum and no chewing gum subset subjects had a significant
decrease in gingivitis scores from baseline to three weeks (p < 0.001
) and from baseline to six weeks (p < 0.05-0.001). There were no signi
ficant statistical differences between the two groups at anytime durin
g the study on gingivitis levels. Chewing gum: after product use, did
not reduce the efficacy of chlorhexidine on gingivitis scores.