Important Risk Information
Warnings: 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.
Most oral sensitivity or pain occurred within the first week of initial chip placement following SRP, was mild-to-moderate in nature and usually resolved itself spontaneously within days. Patients should notify their dentist promptly if pain, swelling, or other problems occur. Infectious events are rare. Abscesses and cellulitis (which have been reported after SRP alone) have been reported with the adjunctive placement of PerioChip® post-SRP. Management of patients with periodontal disease should include consideration of possible underlying medical disorders, such as cancer, diabetes and immune-compromised status. The use of PerioChip® in acutely abscessed periodontal pockets has not been studied and therefore is not recommended. 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 statistically in the PerioChip® group than in the placebo group. These reactions were observed less frequently with subsequent chip placement at three and six months. No long-term adverse events have been documented.
Patients should avoid flossing at the site of PerioChip® for 10 days after insertion. All other oral hygiene procedures may be continued as usual. There are no eating or drinking restrictions. PerioChip® should not be used by any patient who has a known hypersensitivity to Chlorhexidine. PerioChip® should only be used by a pregnant woman if absolutely necessary. The use of PerioChip® in an acutely abscessed periodontal pocket has not been studied and therefore is not recommended. Management of patients with gum disease should include consideration of possible underlying medical disorders, such as cancer, diabetes, and immune-compromised status.
In the unlikely event that the PerioChip® dislodges (in the two pivotal clinical trials, only eight chips were reported lost), several actions are recommended, depending on the day the PerioChip®dislodges. If the chip dislodges seven days or more after placement, your dentist may consider a full course of treatment
If the PerioChip® dislodges within 48 hours after placement, a new PerioChip® should be inserted.
If dislodgment occurs more than 48 hours after placement, your dentist may not replace the PerioChip®, but reevaluate at three months and insert a new PerioChip® if the pocket depth has not been reduced to less than 5 mm.