WARNINGS
Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine.
PRECAUTIONS
General
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 planing. Management of patients with periodontal disease should include consideration of potentially contributing medical disorders, such as cancer, diabetes, and immunocompromised status.
Information for Patients
Patients should be advised to 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.
Patients should avoid dental floss at the site of PerioChip insertion for 10 days after placement, because flossing might dislodge the chip. All other oral hygiene may be continued as usual. No restrictions regarding dietary habits are needed. Dislodging of the PerioChip is uncommon; however, patients should be instructed to notify the dentist promptly if the PerioChip dislodges. Patients should also be advised that, although some mild to moderate sensitivity is normal during the first week after placement of PerioChip, they should notify the dentist promptly if pain, swelling, or other problems occur.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Chlorhexidine gluconate has not been evaluated for carcinogenic potential in connection with the PerioChip. No evidence that chlorhexidine gluconate has potential to cause genetic toxicity was obtained in a battery of mutagenicity studies, including (in vitro) an Ames assay, a chromosome aberration assay in CHO cells, and (in vivo) a micronucleus assay conducted in mice.
Pregnancy
Teratogenic Effects:
Pregnancy Category C – Animal reproduction studies have not been conducted in relation to PerioChip, because animal models that would permit use of a clinically relevant route of administration are not available. Chlorhexidine gluconate did not induce harm to the fetus when administered to rats by gavage at dosages up to 68.5 mg/kg/day. While chlorhexidine is known to be very poorly absorbed from the GI tract, it may be absorbed following placement within a periodontal pocket. Therefore, it is unclear whether these data are relevant to clinical use of PerioChip. In clinical studies, placement of four chips within periodontal pockets resulted in plasma concentrations of chlorhexidine that were at or below the limit of detection. However, it is not known whether PerioChip can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. PerioChip should be used in a pregnant woman only if clearly needed.
Pediatric Use: The safety and effectiveness of PerioChip in pediatric patients have not been established.
Geriatric Use: Although subjects aged 65 years and over were included in clinical studies of PerioChip, there were not sufficient numbers of these subjects to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Overall differences in safety or effectiveness have not been identified between the elderly and younger patients.
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