## 3 Results
### Patient Compliance and PROMs  
Both groups demonstrated a similar degree of compliance, as measured by the amount of remaining toothpaste in the returned tubes (Table 2), with a tendency for a higher consumption of toothpaste in the control group for the 3-6 week period (\(p=0.059\)).  
The results did not reveal any statistically significant difference between treatment groups in terms of the subject's appreciation of the assigned toothpaste in terms of consistency, aroma, taste, amount of foam, cleanness feeling, healthier mouth, fresher mouth and breath, less swollen and bleeding gums, \"stronger gum\" and \"stronger tooth\" feeling (Table 3). However, patients in the test group mentioned that they felt that the toothpaste removed less plaque than normal, which did not occur in the control group (\(p=0.017\)). Both groups indicated that they would buy and recommend the assigned product.  
\begin{table}
\begin{tabular}{c c c c c c c c} \hline \hline  & \multicolumn{2}{c}{**Test Group**} & \multicolumn{2}{c}{**Control Group**} & \multicolumn{2}{c}{**Control Group**} & \multicolumn{1}{c}{\(p\)} \\ \cline{2-7}  & **Mean (SD)** & **Mean (SD)** & **Mean (SD)** & **Lower Bound** & **Upper Bound** & \\ \hline
**n** & 28 & 22 & & & & \\ \hline
**3 weeks** & 59.67 (33.35) & 61.12 (38.70) & \(-\)1.456 & \(-\)21.96 & 19.04 & 0.887 \\ \hline
**6 weeks** & 61.67 (35.51) & 41.48 (38.20) & 20.192 & \(-\)0.83 & 41.22 & 0.059 \\ \hline
**Total** & 122.10 (41.45) & 107.19 (51.10) & 14.915 & \(-\)11.39 & 41.22 & 0.260 \\ \hline \hline \end{tabular}  
* n: sample size; SD: standard deviation; CI: confidence interval.  
\end{table}
Table 2: Remaining amount of toothpaste, in milligrams, after each follow-up visit, analyzed with Student’s \(t\)-test.  
\begin{table}
\begin{tabular}{l c c c c c c} \hline \hline  & \multicolumn{2}{c}{**Test Group**} & \multicolumn{2}{c}{**Control Group**} & \multicolumn{1}{c}{\(p\)} \\ \hline  & **n** & **Mean (SD)** & **Median (IQR)** & **n** & **Mean (SD)** & **Median (IQR)** & \\ \hline
**Consistency** & 30 & 3.66 (0.37) & 3.75 (0.50) & 30 & 3.70 (0.38) & 4.00 (0.50) & 0.683 \\ \hline
**Aroma** & 30 & 3.50 (0.45) & 3.50 (1.00) & 30 & 3.56 (0.44) & 3.50 (1.00) & 0.581 \\ \hline
**Taste** & 30 & 3.45 (0.57) & 3.50 (1.00) & 30 & 3.60 (0.48) & 4.00 (1.00) & 0.324 \\ \hline
**Amount of foam** & 30 & 3.50 (0.55) & 3.50 (1.00) & 30 & 3.51 (0.59) & 3.75 (1.00) & 0.794 \\ \hline
**Freshness** & 30 & 3.05 (0.72) & 3.00 (0.50) & 30 & 3.26 (0.61) & 3.25 (1.00) & 0.278 \\ \hline
**Cleanness feeling** & 30 & 3.26 (0.66) & 3.50 (0.63) & 30 & 3.38 (0.55) & 3.25 (1.00) & 0.672 \\ \hline
**Healthier teeth feeling** & 30 & 3.03 (0.66) & 3.00 (0.50) & 30 & 3.28 (0.55) & 3.25 (0.63) & 0.119 \\ \hline
**Fresh mouth** & 30 & 3.18 (0.66) & 3.00 (0.63) & 30 & 3.36 (0.61) & 3.50 (1.00) & 0.264 \\ \hline
**Fresh breath** & 30 & 3.08 (0.67) & 3.00 (0.63) & 30 & 3.25 (0.65) & 3.25 (1.00) & 0.278 \\ \hline
**Less swollen gums** & 30 & 3.00 (0.57) & 3.00 (1.00) & 30 & 3.11 (0.72) & 3.00 (1.13) & 0.339 \\ \hline
**Reduced gum bleeding** & 30 & 3.21 (0.61) & 3.00 (0.63) & 29 & 3.15 (0.75) & 3.00 (1.00) & 0.900 \\ \hline
**Lasting reduction of bleeding and swelling** & 30 & 3.01 (0.71) & 3.00 (1.00) & 28 & 3.12 (0.66) & 3.00 (1.38) & 0.671 \\ \hline
**Healthy mouth feeling** & 30 & 3.21 (0.58) & 3.25 (0.50) & 30 & 3.40 (0.59) & 3.50 (1.00) & 0.217 \\ \hline
**Gentle on gums** & 30 & 3.61 (0.42) & 3.50 (0.50) & 30 & 3.60 (0.44) & 3.75 (1.00) & 0.905 \\ \hline
**Sensitive gum care** & 30 & 3.46 (0.57) & 3.50 (1.00) & 30 & 3.43 (0.52) & 3.50 (1.00) & 0.664 \\ \hline \hline \end{tabular}  
\end{table}
Table 3: Mean, standard deviation (SD), median and interquartile range (IQR) for the scores of the toothpaste evaluation items (patient reported outcome measures, PROMs). The analysis is based on the average of the responses to the 3-week and 6-week questionnaires and by means of Mann–Whitney U tests. Answers were given on a scale of 1 to 4, except for the final evaluation of the product (1–10).