IMPORTANT SAFETY INFORMATIONPerioChip® 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.
PerioChip® contains 2.5 mg of chlorhexidine gluconate in a biodegradable matrix of hydrolyzed gelatin (cross-linked with glutaraldehyde). PerioChip® is indicated as an adjunct to scaling and root planing (SRP) procedures for reduction of pocket depth in patients with adult periodontitis. PerioChip® may be used as a part of a periodontal maintenance program, which includes good oral hygiene and scaling and root planing. PerioChip® is recommended for use in periodontal pockets with a pocket depth (PD) greater than or equal to 5 mm. For additional Important Safety Information, click here.
Summary of Warnings
PerioChip® should not be used in a patient who has a known sensitivity to chlorhexidine or in pregnant women. 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.
Summary of General Precautions and Adverse Reactions
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. The use of PerioChip® in an acutely abscessed periodontal pocket has not been studied and therefore is not recommended. Although rare, infectious events including abscesses and cellulitis, (which have been reported after scaling and root planing alone), have also been reported with the adjunctive placement of the PerioChip® post scaling and root planning. Management of patients with periodontal disease should include consideration of potential underlying medical disorders, such as cancer, diabetes, and immunocompromised status. The most frequently observed adverse events in the two pivotal clinical trials were toothache (50.7%), upper respiratory tract infection (28.4%), and headache (27.1%). Toothache was the only adverse reaction that was significantly higher (p = 0.042) in the PerioChip® group when compared to placebo. Patients should avoid flossing near the site of the PerioChip® insertion for 10 days to avoid dislodging the chip. All other normal oral hygiene habits may continue as usual. There are no restrictions on food or drink after treatment. Patients should also be advised that although some mild to moderate sensitivity is normal during the first week after placement of PerioChip®, if pain, swelling, or other problems occur, dentist should promptly be notified. The information on this website is based on the US Prescribing Info for the PerioChip® product. If you live outside of the United States, please contact your dentist. Dental professionals located outside of the US should contact their local PerioChip® distributor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see full Prescribing Information