MATERIALS AND METHODS: A double-blind randomized controlled trial (RCT) on systemically healthy smokers was conducted. A total of 78 smokers, aged 18 to 40 years, were enrolled as per exclusion/inclusion criteria. An alkaline mouthwash was provided to the intervention group and a placebo to control group. Salivary pH and inflammatory biomarker interleukin (IL)-1β levels were evaluated at baseline and at follow-up (14 ± 2 days).
STATISTICAL ANALYSIS: Chi-squared test, independaent t-test, and paired t-test were used to observe the changes in parameters among and between groups before and after intervention using SPSS v16 with a significance level of p≤0.050.
RESULTS: Sixty eight salivary samples were analyzed. All study parameters of the study sample were statistically insignificant between both intervention and control groups at baseline. pH level was 6.56 ± 0.53 at baseline and 6.62 ± 0.45 at follow-up in the intervention group; respective values for control group were 6.70 ± 0.36 and 6.83 ± 0.44 and the changes were not significant (p≥0.071). IL-1β level was 9.39 ± 10.23 pg/µL at baseline and 5.40 ± 6.62 pg/µL at a follow-up in the intervention group and the change was significant (p = 0.001); respective values for the control group were 10.63 ± 11.50, and 9.33 ± 11.73 and the difference was nonsignificant (p = 0.076).
CONCLUSION: This randomized trial indicated that sodium bicarbonate mouth rinse is effective in decreasing IL-1β levels and increasing salivary pH favorable for prevention of oral diseases.