Efficacy of an experimental toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride on gingivitis

Table 2 NBS at Week 6 (mITT population): Primary and secondary endpoints

Comparison between groups^a	Adjusted mean (SE)^b	Adjusted mean difference (SE)^b	95% CI^b	p-value^b	Percentage difference^c	p-value^d
Experimental toothpaste (n = 36) versus negative control toothpaste (n = 38)	9.5 (0.80) 20.5 (0.78)	-11.0 (1.12)	-13.3, -8.8	< 0.0001	-53.8	< 0.0001
Experimental toothpaste (n = 36) versus positive control toothpaste (n = 36)	9.8 (0.71) 9.4 (0.71)	0.4 (1.01)	-1.6, 2.4	0.6960	4.2	0.4488
Positive control Toothpaste (n = 36) versus negative control toothpaste (n = 38)	9.1 (0.85) 20.6 (0.82)	-11.5 (1.18)	-13.8, -9.1	< 0.0001	-55.8	< 0.0001

^a Difference is mean NBS for first product minus second product (experimental minus negative control; experimental minus positive control; and positive control minus negative control), such that a negative difference favors the first product (experimental or positive control). ^b Analysis was performed using ANCOVA model with study product group and gender as factors and baseline NBS as covariate. The estimates were based on separate ANCOVA model using only the data for corresponding comparison. ^c Percentage difference calculated as (adjusted mean difference/adjusted mean of comparison toothpaste)*100. ^dp-value from Van Elteren test (non-parametric)
ANCOVA, analysis of covariance; CI, confidence interval; mITT, modified intent-to-treat; NBS, number of bleeding sites; SE, standard error

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