Periochip
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Periochip
SIDE EFFECTS
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
| 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 |
| Allergy | 9 | 4 | 13 | 5.9 |
| Myalgia | 9 | 4 | 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 |
| 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 |
| *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 |
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Read the Periochip (chlorhexidine) Side Effects Center for a complete guide to possible side effects »
DRUG INTERACTIONS
No information provided.
Last reviewed on RxList: 2/3/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Periochip Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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