Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin

Table 3

Secondary endpoint: change in VAS scores for pain and swelling from baseline.

Secondary endpoint: change in VAS from baseline
Assessment	Day	Statistic	Amoxicillin/clavulanic acid; ()	Clindamycin; ()	Treatment difference
Change in pain at Day from baseline		(missing)	227 ()	233 ()	—
	Day 2	Least square mean	3.34	3.07	0.27
		Two-sided 95% CI (LCL, UCL)	(3.08, 3.61)	(2.81, 3.33)	(−0.10, 0.64)
		(missing)	219 ()	228 ()	—
	Day 5	Least square mean	5.49	5.38	0.11
		Two-sided 95% CI (LCL, UCL)	(5.27, 5.71)	(5.16, 5.60)	(−0.20, 0.42)
		(missing)	57 (0)	71 (0)	—
	Day 7	Least square mean	6.38	6.34	0.04
		Two-sided 95% CI (LCL, UCL)	(6.02, 6.74)	(6.02, 6.66)	(−0.44, 0.53)
Change in swelling at Day from baseline		(missing)	219 ()	225 ()	—
	Day 2	Least square mean	1.92	1.61	0.31
		Two-sided 95% CI (LCL, UCL)	(1.72, 2.11)	(1.42, 1.80)	(0.04, 0.57)
		(missing)	214 ()	223 (3)	—
	Day 5	Least square mean	3.68	3.60	0.08
		Two-sided 95% CI (LCL, UCL)	(3.51, 3.85)	(3.43, 3.76)	(−0.16, 0.32)
		(missing)	55 (0)	68 (0)	—
	Day 7	Least square mean	4.21	4.61	−0.39
		Two-sided 95% CI (LCL, UCL)	(3.94, 4.49)	(4.36, 4.86)	(−0.77, −0.02)

Note: change from baseline in VAS for assessment of pain and swelling was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood and an unstructured covariance matrix. The baseline VAS score was used as a covariate. Treatment groups and nominal days (visits) were considered as fixed effects and interaction effect was considered between treatment and visit (days). Data for “Day 7” is summarised for subjects who continued the study up to Day 7. OC method was used for missing values where the missing value was kept as missing except for early withdrawal.
“” indicates Day 2, or Day 5, or Day 7 as applicable.
LCL: lower confidence limit, UCL: upper confidence limit.
means the interaction effect between treatment and visits (days).