Table 4.
Statistical analysis of change from baseline in response to the DHEQ Sect. 2, (Q1–Q15) total score for all domains and each domain at Week 8 in the mITT population
| Domain | Visit | Study product | n | Adjusted mean (SE)a | 95% CIa | p-valuea | Adjusted mean difference (SE)a | Adjusted mean difference (%) | 95% CIa | p-valueb |
|---|---|---|---|---|---|---|---|---|---|---|
| Total score | Week 8 | Test | 65 | –11.28 (2.238) | –15.69, –6.86 | < 0.0001 | –2.96 (3.140) | 35.6 | –9.15, 3.23 | 0.1188 |
| Positive control | 64 | –11.30 (2.256) | –15.75, –6.85 | < 0.0001 | –2.98 (3.153) | 35.9 | –9.20, 3.24 | 0.4759 | ||
| Negative control | 67 | –8.32 (2.202) | –12.66, –3.98 | 0.0002 | ||||||
| Restrictions domain (Q1–Q3) | Week 8 | Test | 65 | –2.03 (0.468) | –2.96, –1.11 | < 0.0001 | -0.43 (0.658) | 27.0 | –1.73, 0.87 | 0.2667 |
| Positive control | 64 | –1.81 (0.472) | –2.74, –0.88 | 0.0002 | -0.21 (0.660) | 12.9 | –1.51, 1.10 | 0.9649 | ||
| Negative control | 67 | –-1.60 (0.461) | –2.51, –0.69 | 0.0006 | ||||||
| Adaptation domain (Q4–Q6) | Week 8 | Test | 65 | –2.48 (0.474) | –3.41, –1.54 | < 0.0001 | –0.75 (0.665) | 43.5 | –2.06, 0.56 | 0.2712 |
| Positive control | 64 | –2.54 (0.478) | –3.48, –1.60 | < 0.0001 | –0.81 (0.668) | 47.2 | –2.13, 0.50 | 0.3270 | ||
| Negative control | 67 | –1.72 (0.466) | –2.65, –0.80 | 0.0003 | ||||||
| Social impact domain (Q7–Q9) | Week 8 | Test | 65 | –2.32 (0.485) | –3.28, –1.36 | < 0.0001 | –0.62 (0.680) | 36.8 | –1.97, 0.72 | 0.1997 |
| Positive control | 64 | –2.24 (0.489) | –3.21, –1.28 | < 0.0001 | –0.55 (0.682) | 32.3 | –1.89, 0.80 | 0.7862 | ||
| Negative control | 67 | –1.70 (0.476) | –2.64, –0.76 | 0.0005 | ||||||
| Emotional impact domain (Q10–Q12) | Week 8 | Test | 65 | –2.17 (0.481) | –3.12, –1.22 | < 0.0001 | –0.61 (0.675) | 39.4 | –1.95, 0.72 | 0.2292 |
| Positive control | 64 | –2.13 (0.486) | –3.09, –1.18 | < 0.0001 | –0.58 (0.680) | 37.1 | –1.92, 0.76 | 0.8382 | ||
| Negative control | 67 | –1.56 (0.474) | –2.49, –0.62 | 0.0012 | ||||||
| Identity domain (Q13–Q15) | Week 8 | Test | 65 | –2.25 (0.521) | –3.28, –1.22 | < 0.0001 | –0.53 (0.731) | 30.6 | –1.97, 0.92 | 0.2284 |
| Positive control | 64 | –2.63 (0.524) | –3.66, –1.60 | < 0.0001 | –0.91 (0.733) | 52.6 | –2.35, 0.54 | 0.3146 | ||
| Negative control | 67 | –1.72 (0.513) | –2.73, –0.71 | 0.0009 |
aAnalysis is performed using ANCOVA model with study product and baseline Schiff stratification as factors and baseline score of relevant parameter included as a covariate. bP-value from van Elteren test
Adjusted mean difference is calculated as test/positive control minus negative control such that a negative difference favours test/positive control
Adjusted mean difference (%) is calculated as 100 x (adjusted mean difference/adjusted mean of negative control)
Positive % adjusted mean difference favours test/positive control
All five functional domains (restrictions, adaptations, social impact, emotional impact and identity) have domain scores ranging from 3–21
Total score is for all 15 questions and has a range of 15–105
Test Sensodyne Sensitivity and Gum®, Negative control Crest Cavity Protection®, Positive control Sensodyne Repair and Protect®
CI confidence interval, DHEQ dentine hypersensitivity experience questionnaire, mITT modified intent-to-treat, n number of observations, SE standard error