Skip to main content

Table 3 Summary of statistical analysis for NBS, BI, MGI and TPI endpoints

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

Comparison between groupsa

Parameter

Visit

Adjusted mean

difference (SE)b

95% CIb

Percentage differencec

p-valued

Experimental toothpaste (n = 36)

versus

negative control toothpaste (n = 38)

NBS

Day 3

Week 1

Week 2

Week 6

-2.0 (0.48)

-5.2 (0.75)

-8.9 (1.07)

-11.0 (1.12)

-3.0, -1.1

-6.7, -3.8

-11.1, -6.8

-13.3, -8.8

-7.1

-19.9

-38.8

-53.8

0.6284

0.0029

< 0.0001

< 0.0001

BI

Day 3

Week 1

Week 2

Week 6

-0.023 (0.0049)

-0.043 (0.0061)

-0.059 (0.0075)

-0.070 (0.0066)

-0.032, -0.013

-0.055, -0.030

-0.074, -0.044

-0.083, -0.057

-11.59

-24.35

-39.96

-54.57

0.9769

0.0105

< 0.0001

< 0.0001

MGI

Day 3

Week 1

Week 2

Week 6

-0.048 (0.0095)

-0.117 (0.0141)

-0.205 (0.0201)

-0.305 (0.0286)

-0.067, -0.030

-0.145, -0.089

-0.245, -0.165

-0.362, -0.248

-2.36

-5.77

-10.61

-16.58

0.0720

< 0.0001

< 0.0001

< 0.0001

TPI (overall)

Day 3

Week 1

Week 2

Week 6

-0.042 (0.0321)

-0.068 (0.0410)

-0.161 (0.0466)

-0.252 (0.0386)

-0.106, 0.022

-0.150, 0.014

-0.254, -0.068

-0.329, -0.175

-1.8

-3.0

-7.5

-11.9

0.7516

0.4290

0.0876

0.0008

TPI (interproximal)

Day 3

Week 1

Week 2

Week 6

-0.048 (0.0348)

-0.057 (0.0431)

-0.131 (0.0463)

-0.248 (0.0373)

-0.117, 0.022

-0.143, 0.029

-0.224, -0.039

-0.322, -0.174

-2.0

-2.5

-6.0

-11.4

0.7355

0.8315

0.2724

0.0006

Experimental toothpaste (n = 36)

versus

positive control toothpaste (n = 36)

NBS

Day 3

Week 1

Week 2

Week 6

0.4 (0.63)

0.8 (0.89)

1.0 (1.02)

0.4 (1.01)

-0.8, 1.7

-1.0, 2.6

-1.0, 3.0

-1.6, 2.4

1.5

3.8

7.2

4.2

0.5579

0.2009

0.5139

0.4488

BI

Day 3

Week 1

Week 2

Week 6

-0.002 (0.0048)

-0.001 (0.0067)

0.007 (0.0068)

0.003 (0.0063)

-0.012, 0.008

-0.014, 0.013

-0.007, 0.020

-0.009, 0.016

-1.10

-0.64

7.70

5.64

0.6531

0.8321

0.3952

0.3639

MGI

Day 3

Week 1

Week 2

Week 6

0.021 (0.0109)

0.009 (0.0185)

0.066 (0.0295)

-0.032 (0.0337)

-0.001, 0.042

-0.028, 0.046

0.007, 0.125

-0.100, 0.035

1.03

0.48

3.93

-2.03

0.7858

0.3416

0.1355

0.2630

TPI (overall)

Day 3

Week 1

Week 2

Week 6

0.006 (0.0301)

0.026 (0.0343)

0.059 (0.0355)

0.045 (0.0361)

-0.055, 0.066

-0.043, 0.094

-0.012, 0.130

-0.027, 0.117

0.2

1.2

3.0

2.5

0.4707

0.0986

0.0299

0.1615

TPI (interproximal)

Day 3

Week 1

Week 2

Week 6

0.008 (0.0337)

0.023 (0.0383)

0.063 (0.0352)

0.023 (0.0360)

-0.060, 0.075

-0.053, 0.100

-0.008, 0.133

-0.048, 0.095

0.3

1.0

3.1

1.2

0.3712

0.0729

0.0141

0.2069

Positive control toothpaste (n = 36)

versus

negative control toothpaste (n = 38)

NBS

Day 3

Week 1

Week 2

Week 6

-2.4 (0.57)

-6.1 (0.86)

-9.8 (1.29)

-11.5 (1.18)

-3.5, -1.3

-7.8, -4.4

-12.4, -7.2

-13.8, -9.1

-8.3

-23.0

-42.6

-55.8

0.5544

0.0008

< 0.0001

< 0.0001

BI

Day 3

Week 1

Week 2

Week 6

-0.022 (0.0050)

-0.044 (0.0067)

-0.067 (0.0093)

-0.074 (0.0077)

-0.032, -0.012

-0.057, -0.030

-0.086, -0.049

-0.090, -0.059

-11.19

-24.57

-45.42

-57.27

0.8981

0.0104

< 0.0001

< 0.0001

MGI

Day 3

Week 1

Week 2

Week 6

-0.065 (0.0091)

-0.125 (0.0156)

-0.262 (0.0265)

-0.281 (0.0306)

-0.083, -0.046

-0.156, -0.093

-0.315, -0.209

-0.342, -0.220

-3.13

-6.12

-13.53

-15.18

0.0124

< 0.0001

< 0.0001

< 0.0001

TPI (overall)

Day 3

Week 1

Week 2

Week 6

-0.048 (0.0333)

-0.110 (0.0333)

-0.220 (0.0340)

-0.295 (0.0342)

-0.114, 0.019

-0.176, -0.044

-0.288, -0.152

-0.363, -0.227

-2.0

-4.8

-10.3

-14.0

0.6576

0.0390

< 0.0001

< 0.0001

TPI (interproximal)

Day 3

Week 1

Week 2

Week 6

-0.053 (0.0367)

-0.095 (0.0354)

-0.192 (0.0359)

-0.269 (0.0334)

-0.126, 0.021

-0.166, -0.025

-0.264, -0.120

-0.335, -0.202

-2.2

-4.2

-8.8

-12.5

0.7204

0.1379

< 0.0001

< 0.0001

  1. a Difference is mean NBS, BI, MGI and TPI 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 the following factors: For NBS: study product group and gender as factors and baseline NBS as covariate; for BI: study product group, gender and NBS strata as factors, and baseline BI score as covariate; for MGI: study product group, gender and NBS strata as factors, and baseline MGI score as covariate; for TPI (overall): study product group, gender and NBS strata as factors and baseline overall TPI score as covariate; for TPI (interproximal): study product group, gender and NBS strata as factors and baseline interproximal TPI score as covariate
  2. c Percentage difference calculated as (adjusted mean difference/adjusted mean of comparison toothpaste)*100. dp-value from Van Elteren test (non-parametric)
  3. ANCOVA, analysis of covariance; BI, Bleeding Index; CI, confidence interval; MGI, Modified Gingival Index, NBS, number of bleeding sites; SE, standard error; TPI, Turesky Plaque Index