## 3 Results
### Analysis of the OHIP-49 Scores  
A statistically significant difference (\(p\) = 0.030, ANCOVA) was detected between the groups for the first time after 8 weeks. The difference between the OHIP-49 scores at the endpoint and the scores at baseline represented the primary efficacy variable. It was analyzed in the ITT population (n = 273). Generally, lower OHIP-49 scores indicate better oral health-related conditions. Table 2 indicates the OHIP-49 scores at various visits. This section may be divided by subheadings. It should provide a concise and precise description of the experimental results, their interpretation, as well as the experimental conclusions that can be drawn. The OHIP-49 score after 24 weeks (adjusted for baseline) in the test group was significantly lower than the OHIP-49 score in the control group (\(p\) = 0.005, ANCOVA). The 95% CIs for the estimated mean difference in the OHIP-49 score between the test group and the control group after 24 weeks (adjusted for baseline) accounted for [\(-8.615\); \(-1.513\)]. These findings confirmed that the OHIP-49 score was significantly lower in the test group than in the control group at the endpoint. The descriptive statistics are summarized in Table 3.  
Figure 1 represents that there were no significant center effects on the primary outcome (OHIP-49 score). Covariates appearing in the model are evaluated at the following values: OHIP-49 score at baseline = 26.2247. Each of the three centers showed a significantly lower OHIP-49 score in the test group than in the control group (\(p\) = 0.005, ANCOVA). When the pain-related items of the OHIP-49 score were considered separately, patients in the test group showed a significantly lower score than those in the control group after 8 weeks (\(p\) = 0.037, ANCOVA) and after 24 weeks (\(p\) = 0.025, ANCOVA). The OHIP-49 was administered at baseline and after 4, 8, and 24 weeks of therapy. Changes in the OHIP-49 scores compared to the previous scores were analyzed as secondary effectiveness variables (Table 4). \begin{table}
\begin{tabular}{c c c} \hline \hline  & \multicolumn{3}{c}{**Score (Mean \(\pm\) SD)**} \\ \cline{2-3}
**Visit** & **Test Group (n = 137)** & **Control Group (n = 136)** \\ \hline
**Baseline** & 27.3 \(\pm\) 18.5 & 24.9 \(\pm\) 19.4 \\
**4 Weeks** & 21.6 \(\pm\) 18.5 & 20.0 \(\pm\) 18.8 \\
**8 Weeks** & 17.5 \(\pm\) 15.6 & 19.4 \(\pm\) 19.2 \\
**24 Weeks** & 16.0 \(\pm\) 15.3 & 19.8 \(\pm\) 20.2 \\ \hline \hline \end{tabular} OHIP: Oral Health Impact Profile, SD: standard deviation.  
\end{table} 
Table 2: The OHIP-49 scores at various study visits. \begin{table}
\begin{tabular}{c c c c c c c c} \hline \hline  & \multicolumn{3}{c}{**Descriptive Statistics**} & \multicolumn{3}{c}{**Estimates**} \\ \hline
**Group** & **N** & **Mean** & **SD** & **Mean** & **SE** & \
\begin{tabular}{c} **95\% CI,** \\ **Lower Bound** \\ \end{tabular} &
\begin{tabular}{c} **95\% CI,** \\ **Upper Bound** \\ \end{tabular} \\ \hline
**Test** & 137 & 16.0 & 15.3 & 15.4 a ** & 1.3 & 12.9 & 17.9 \\ \hline
**Control** & 136 & 19.8 & 20.2 & 20.4 a ** & 1.3 & 17.9 & 23.0 \\ \hline
**Total** & 273 & 17.9 & 18.0 & & & \\ \hline \hline \end{tabular}
\end{table} 
Table 3: Descriptive statistics and estimates of the OHIP-49 score at endpoint (dependent variable). The OHIP-49 scores were statistically analyzed using ANCOVA and confirmed by the Mann-Whitney U test (Table 5). The OHIP-49 scores were significantly lower in the test group than in the control group (\(p\) = 0.030, ANCOVA) after 8 weeks of treatment. The same effect was observed when the pain-related items were considered separately (\(p\) = 0.037, ANCOVA).