Table 2.
Statistical analysis of change from baseline in Schiff sensitivity score over time in the mITT population
| Change from baseline | Comparison with negative control | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Visit | Study product | n | Baseline Schiff score (mean ± SD) | Adjusted mean (SE)a | 95% CIa | p-valuea | Adjusted mean difference (SE)a | Adjusted mean difference (%) | 95% CIa | p-valuea |
| Week 4 | Test | 64 | 2.50 ± 0.442 | –0.79 (0.082) | –0.95, –0.63 | < 0.0001 | –0.03 (0.115) | 4.6 | –0.26, 0.19 | 0.7645 |
| Positive control | 64 | 2.47 ± 0.435 | –0.76 (0.082) | –0.92, –0.60 | < 0.0001 | –0.00 (0.1114) | 0.5 | –0.23, 0.22 | 0.9728 | |
| Negative control | 67 | 2.43 ± 0.425 | –0.75 (0.080) | –0.91, –0.60 | < 0.0001 | |||||
| Week 8 | Testb | 65 | –0.98 (0.099) | –1.18, –0.79 | < 0.0001 | 0.16 (0.140) | –13.7 | –0.12, 0.43 | 0.2639 | |
| Positive control | 64 | –0.99 (0.100) | –1.19, –0.79 | < 0.0001 | 0.15 (0.140) | –12.9 | –0.13, 0.42 | 0.2968 | ||
| Negative control | 67 | –1.14 (0.098) | –1.33, –0.94 | < 0.0001 | ||||||
ANCOVA analysis of covariance, CI confidence interval, mITT modified intent-to-treat, n number of observations, SD standard deviation, SE standard error
aAnalysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate. Positive % adjusted mean difference favours test/positive control
bPrimary endpoint. Test = Sensodyne Sensitivity and Gum®; Negative control = Crest Cavity Protection®; Positive control = Sensodyne Repair and Protect®