Efficacy and Tolerability of a L. and × L.-Based Chewing Gum on the Symptoms of Gingivitis: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Preclinical studies have shown that the combination of × L. and L. extracts exerts beneficial effects on oral health against gingivitis. Thus, this study aimed to assess the tolerability of a chewing gum and its efficacy on gingivitis in a double-blind, placebo-controlled clinical trial. Enrolled subjects ( = 60, 18-70 years) were randomized to receive two chewing gums or a placebo daily for 3 months. At baseline (t0) and monthly (t1, t2, and t3) timepoints, the Quantitative Gingival Bleeding Index (QGBI), the Modified Gingival Index (MGI), and the Oral Health 15 items (OH-15)] were employed to assess potential improvements in gingivitis. Pain was self-quantified via the Visual Analogue Scale (VAS), and the Clinical Global Impression Scale for Severity of illness (CGI-S) helped in evaluating the oral general conditions. This study is listed on the ISRCTN registry. At t3, the QGBI, MGI, OH-15, VAS, and CGI-S values decreased in the treated but not in the placebo group (β = 0.6 ± 0.1, t = 3.680, < 0.001; β = 0.87 ± 0.21, t = 4.263, < 0.001; β = 5.3 ± 2.5, t = 2.086, = 0.038; β = 3.16 ± 0.51, t = 6.253, < 0.001; and β = 1.09 ± 0.32, t = 3.419, < 0.001, respectively). A significant improvement in gingival health occurred after a 3-month intervention with the chewing gums containing and extracts.