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) in the PerioChip group when compared to placebo. Most oral pain or sensitivity occurred within the first week of the initial chip placement following SRP procedures, was mild to moderate in nature, and spontaneously resolved within days. These reactions were observed less frequently with subsequent chip placement at 3 and 6 months.
Table 3 lists adverse events, occurring in ≥ 1% of 225 patients that received PerioChip, pooled from the two pivotal clinic trials without regard to causality. Gingival bleeding was the only dental adverse event occurring at a rate of ≤ 1% in both groups.
Table 3 : Adverse events (frequency ≥ 1% for the PerioChip group) reported from 2 five-center U.S. clinical trials
N = 225
|Placebo Chip Total
N = 222
|All patients with Adverse Events||193||85.8||189||85.1|
|Upper resp tract infection||64||28.4||58||26.1|
|*Includes dental, gingival or mouth pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity
** Includes broken, cracked or fractured teeth, mobile teeth, and lost bridges, crowns, or fillings