Periochip (Chlorhexidine Gluconate) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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 clinical 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

* 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
	PerioChip Total N = 225		Placebo Chip Total N = 222
	N	%	N	%
All patients with Adverse Events	193	85.8	189	85.1
Toothache*	114	50.7	92	41.4
Upper resp tract infection	64	28.4	58	26.1
Headache	61	27.1	61	27.5
Sinusitis	31	13.8	29	13.1
Influenza-like-symptoms	17	7.6	21	9.5
Back pain	15	6.7	25	11.3
Tooth disorder**	14	6.2	15	6.8
Bronchitis	14	6.2	7	3.2
Abscess	13	5.8	13	5.9
Pain	11	4.9	11	5.0
Allergy	9	4.0	13	5.9
Myalgia	9	4.0	9	4.1
Gum hyperplasia	8	3.6	5	2.3
Pharyngitis	8	3.6	5	2.3
Arthralgia	7	3.1	13	5.9
Dysmenorrhea	7	3.1	13	5.9
Dyspepsia	7	3.1	6	2.7
Rhinitis	6	2.7	11	5.0
Coughing	6	2.7	7	3.2
Arthrosis	6	2.7	4	1.8
Hypertension	5	2.2	6	2.7
Stomatitis ulcerative	5	2.2	1	0.5
Tendinitis	5	2.2	1	0.5