A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Periochip Side Effects, and Drug Interactions - Chlorhexidine
Periochip Side Effects, and Drug Interactions - Chlorhexidine
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 ³1%
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 ³1%
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
|
5.0
|
| 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
|
- * 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
DRUG INTERACTIONS
No information provided.
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