For proffesionals

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.

Safety Profile

Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. Patients should report any signs of local adverse reactions to their dentists. Patients who develop allergic symptoms such as skin rash, itch, generalized swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhea, should seek medical attention immediately.

What are the risks associated with PerioChip®?

Most oral sensitivity or pain occurred within the first week of initial chip placement following SRP, was mild-to-moderate in nature, and resolved itself spontaneously within days. These reactions were observed less frequently with subsequent chip placement at 3 and 6 months. Patients should notify the dentist promptly if pain, swelling, or other problems occur. Infectious events, including abscesses and cellulitis, have been reported with the adjunctive placement of PerioChip® post-SRP; however, these events have also been reported after SRP alone. Management of patients with periodontal disease should include consideration of possible underlying medical disorders, such as cancer, diabetes, and immunocompromised status. The most frequently observed adverse events in the two pivotal clinical trials were toothache, upper respiratory tract infection and headache. Toothache was the only adverse reaction that was significantly higher (p=0.042) statistically in the PerioChip® group (50.7%) versus the placebo group (41.4%).