Abstract
BACKGROUND: This randomized double-blind, placebo-controlled clinical trial evaluated the effects of 2% OPTIMEALTH® OR toothpaste in regulating dental plaque microbiota and alleviating gingivitis. METHODS: Subjects were randomly assigned to the placebo group and test group. They were instructed to brush their teeth with placebo toothpaste (placebo group) or OPTIMEALTH® OR toothpaste (test group) for a continuous 4 weeks. Clinical indices of plaque index, gingival index, and bleeding on probe (%) were examined, and images of dental plaque staining were captured at baseline and after 2 and 4 weeks. The plaque microbiome was analyzed by 16s rDNA amplicon sequencing at baseline and after 4 weeks. RESULTS: Thirty-two participants with similar characteristics were recruited. After using OPTIMEALTH® OR toothpaste for 4 weeks, a decrease of 27.05% (P < .01), 8.29% (P > .05), and 47.44% (P < .05) in plaque index, gingival index, and bleeding on probe (%) scores was observed compared to the baseline, respectively. The extent of decline in these indices is greater than that in the placebo group. A decrease in dental plaque could be observed after 2 and 4 weeks in the test group. The 16s rDNA sequencing results showed that the observed species index and Chao index, but not the Shannon index and beta diversity, were reduced significantly after using OPTIMEALTH® OR toothpaste for 4 weeks. In addition, compared with the placebo group, using OPTIMEALTH® OR toothpaste reduced the abundance of bacterial species such as Veillonella parvula and Prevotella denticola. CONCLUSION: Brushing teeth with 2% OPTIMEALTH® OR-fortified toothpaste could effectively reduce dental plaque and regulate plaque microbiota.