The effect of an oral spray containing an aqueous extract of Triticum vulgare on dental plaque and gingival inflammation in schoolchildren: A randomized controlled trial.

To investigate whether the daily use of a spray containing an aqueous extract of Triticum vulgare (TV), belonging to the family of Graminaceae, associated with supervised toothbrushing may improve gingival health in schoolchildren with mixed dentition. Study design: Randomised, controlled, single-centre, examiner blind, parallel-group study. The study population included 57 schoolchildren with plaque-induced gingivitis randomly allocated to test (n = 29) and control (n = 28) group. Both groups were enrolled in a mechanical plaque control programme for a period of 2 weeks. The test group was also instructed to use a gluten free spray formulation of TV spray twice daily after toothbrushing. Evaluations of plaque index, modified gingivitis index (GI), salivary pH and whole stimulated saliva quantity took place at baseline and after 1 and 2 weeks of study product use. No side effects were observed. Plaque accumulation and GI statistically significantly improved compared with baseline in both groups (all P-values < 0.005), while salivary pH remained nearly unchanged. Between-group differences in index reduction were statistically significant only for GI favouring the test group (P = 0.013). Repeated-measures ANOVA and the Friedman test were applied to evaluate the influence of time on quantitative variables within each treatment group. Differences between test and control groups were tested using the unpaired t test or the Mann-Whitney U-test with Bonferroni correction. This study found that TV in spray formulation is safe and effective in controlling gingival inflammation. Thus, it may be a potential adjuvant in the treatment of gingivitis in combination with mechanical plaque control in schoolchildren.