For Professionals

Clinical Info

For healthcare professionals
IMPORTANT SAFETY INFORMATION
PerioChip® should not be used in any patient who has a known sensitivity to chlorhexidine. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine.

Clinical Studies

In two double-blind, randomized, controlled clinical trials, 447 adult patients with periodontitis, who had at least 4 pockets with probing depth of 5-8 mm that bled upon probing were entered. Patients studied were in good general health. Diabetics were excluded from both studies. PerioChip®(Chlorhexidine Gluconate) 2.5mg was not studied in acutely abscessed periodontal pockets. Patients were free of supragingival calculus prior to baseline. In these two studies, the effects of SRP alone, and SRP followed by PerioChip® treatment, were compared. All patients received full mouth SRP at baseline. lf the patients’ pocket depth remained >/=5 mm at 3 and/or 6 months after initial treatment, another chip was placed into the pocket. Teeth treated with PerioChip® were found to have significantly reduced probing pocket depth (PD) compared with those treated with SRP alone at 9 months after initial treatment, as shown in Table 1.

PerioChip® treatment resulted in an improvement in PD of 2 mm or more compared with SRP alone at 9 months,in a greater percentage of patients’ pockets, as shown in Table 2. The differences in improvement were statistically significant when analyzed on a per patient basis (p<0.005). PerioChip® treatment maintained probing attachment level (PAL) compared with baseline or with SRP alone at 9 months. The effects of PerioChip® on bleeding upon probing have not been established. In the two studies, there were no significant changes in plaque development or gingivitis. Smokers and non-smokers were enrolled in these studies; although non-smokers using PerioChip® demonstrated significant improvement in PD, smokers demonstrated a trend towards improvement that did not reach statistical significance. This finding is consistent with the consensus that smoking is a risk factor in periodontal diseases.

 

 

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