A randomized controlled trial to evaluate the effectiveness of a novel mouth rinse in patients with gingivitis

Bianca A Newman, Claire N Rosebrough, Ryan A Tamashiro, Ana P Dias Ribeiro, Joan A Whitlock, Gurjit Sidhu, Ikramuddin Aukhil, Dianne Y Porral, Ann Progulske-Fox, Matthew F Myntti, Gary P Wang, Bianca A Newman, Claire N Rosebrough, Ryan A Tamashiro, Ana P Dias Ribeiro, Joan A Whitlock, Gurjit Sidhu, Ikramuddin Aukhil, Dianne Y Porral, Ann Progulske-Fox, Matthew F Myntti, Gary P Wang

Abstract

Background: This single-center, randomized controlled trial aimed to determine the effectiveness of a novel, biofilm-disrupting, mouth rinse that combines Cetylpyridinium chloride (CPC) and essential oils in preventing re-accumulation of supragingival plaque and supragingival microbiome in patients with gingivitis after dental prophylaxis.

Methods: One hundred eighteen participants were randomly assigned in a 1:1 ratio to receive twice-daily test mouth rinse (59) or carrier rinse control (59) for 12 weeks after dental prophylaxis.

Results: In a per-protocol analysis that included patients who completed the intervention, the treatment group (39) had significantly lower supragingival plaque scores at 6 and 12 weeks compared to the control group (41; p = 0.022). Both groups showed similar improvement in gingivitis score, but neither group had improvement in bleeding score or probing depth. Thirty-eight (29%) patients did not complete the study due to loss of follow-up (17) or early discontinuation of the assigned intervention (21). Microbiome sequencing showed that the treatment rinse significantly depleted abundant and prevalent members of the supragingival plaque microbiome consortium.

Conclusions: Among patients with gingivitis, the novel mouth rinse significantly reduced re-accumulation of supragingival plaque following dental prophylaxis by depleting supragingival plaque microbiome. However, long-term adherence to the rinse may be limited by adverse effects ( ClinicalTrials.gov number, NCT03154021).

Keywords: Antimicrobial(s); Antiplaque agent(s); Clinical trial(s); Dental hygiene; Gingivitis; Supragingival microbiome.

Conflict of interest statement

Dr. Matthew Myntti is the Chief Technology Officer of Next Science and is a shareholder. Dianne Porral is a full-time employee of Next Science and is also a shareholder.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Randomization and follow up of the patients
Fig. 2
Fig. 2
Shifts in the supragingival microbiome after 12 weeks of oral rinse use. a Three alpha diversity metrics comparing oral rinses over time. Species richness was estimated by the number of observed OTUs and Faith’s phylogenetic diversity, and species diversity was measured by Shannon’s diversity index. Boxplots show the median and interquartile range (IQR). Whiskers extend up to 1.5 x IQR with points beyond representing outliers. See Supplementary Table for significance tests. b Principal coordinates analysis on weighted UniFrac distances comparing the treatment and the control groups at baseline and at 12 weeks. P values were generated using permutational multivariate analysis of variance with 999 permutations. c Comparison of the longitudinal change in the microbiome over 12 weeks of rinse use. Within-subject UniFrac distance quantifies the change in a single individual’s microbiome over time, with greater distances representing more change. Black bars show the mean within-subject UniFrac distance, and p value was generated using a Wilcoxon rank sum test. d Top 20 taxa that were most differentially abundant between the two groups after 12 weeks of oral rinse use. Linear discriminant analysis with effect size identified specific OTUs differentially enriched in the control or the treatment group, indicated by color. See Supplementary fig. 2 for all differentially abundant OTUs. NS: Next Science oral rinse, OTU: Operational taxonomic unit

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