Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin
Table 1
Summary of demographics and baseline characteristics (ITT population).
Characteristic
Statistic
Randomised treatment arm
Amoxicillin/clavulanic acid ()
Clindamycin ()
Gender
Male
(%)
99 (42.3%)
94 (39.7%)
Female
(%)
135 (57.7%)
143 (60.3%)
Geographic ancestry
Asian: Central/South Asian heritage
(%)
0
1 (0.4%)
Asian: East Asian heritage
(%)
1 (0.4%)
4 (1.7%)
Asian: South East Asian heritage
(%)
233 (99.6%)
232 (97.9%)
Age (years)
(missing)
234 (0)
237 (0)
Mean (SD)
33.1 (12.8)
32.6 (12.0)
Median
29.2
28.9
(Min, max)
(18.0, 74.8)
(18.1, 69.0)
Type of odontogenic infection
Periapical abscess
(%)
133 (56.8%)
130 (54.9%)
Acute periodontitis
(%)
40 (17.1%)
37 (15.6%)
Pericoronitis
(%)
62 (26.5%)
73 (30.8%)
Diagnostic criteria fulfilled
Dental pain which is increased on mastication
(%)
234 (100.0%)
237 (100.0%)
Swelling on alveolar mucosa
(%)
226 (96.6%)
227 (95.8%)
Redness over involved region
(%)
215 (91.9%)
219 (92.4%)
Increased tooth mobility
(%)
82 (35.0%)
75 (31.6%)
Fever
(%)
5 (2.1%)
5 (2.1%)
Malaise
(%)
17 (7.3%)
21 (8.9%)
Cervical lymphadenopathy
(%)
27 (11.5%)
26 (11.0%)
Elevated leucocyte count
(%)
37 (15.8%)
37 (15.6%)
Baseline VAS score
Dental pain
(missing)
234 (0)
237 (0)
Mean (SD)
6.5 (2.1)
6.5 (2.1)
Median
7.0
6.5
(Min, max)
(1.0, 10.0)
(0.5, 10.0)
Swelling
(missing)
226 (8)
227 (10)
Mean (SD)
4.2 (1.9)
4.5 (2.1)
Median
4.0
4.0
(Min, max)
(0.6, 10.0)
(0.1, 10.0)
Surgical intervention required prior to study treatment
(%)
55 (23.5%)
55 (23.2%)
Percentage is calculated based on number of subjects in ITT population for each treatment arm and by actual randomised arm. As per randomisation, there were 234 subjects in amoxicillin/clavulanic acid arm and 237 in clindamycin arm but due to wrong randomisation process, two subjects were administered amoxicillin/clavulanic acid instead of clindamycin. Hence as per actual treatment received, there were 236 subjects in amoxicillin/clavulanic acid arm and 235 subjects in clindamycin arm.
