A randomized controlled trial on the effect of multiple-enzyme treatment on dental plaque formation

Background and aim: Matrix-degrading enzymes are a promising approach to plaque control that destabilizes the biofilm and facilitates removal without disrupting oral microbial homeostasis. This triple-blind randomized controlled trial aimed to investigate the treatment effect of a lozenge containing mutanase, beta-glucanase and DNase in two different concentrations on de novo plaque formation in healthy individuals.<br/>Methods: The study was approved by the Ethical Committee of Region Midtjylland (1-10-72-259-21). Subjects were randomly allocated to either Placebo (n=27), Active 1 (n=27) or Active 2 (n=26; threefold enzyme activity). Plaque formation in the absence of self-performed oral hygiene was assessed after 1, 7 and 14 days of intervention using the Turesky modification of the Quigley and Hein plaque index (TM-QHPI) and the planimetric plaque index (PPI). The PPI was determined by semi-automated planimetry on fluorescence images of disclosed plaque acquired using an intraoral camera. Treatment effects were analyzed using a two-way analysis of variance model.<br/>Results: Significantly lower plaque formation was observed after 7 days of intervention for the Active 1 group compared to Placebo (TM-QHPI: 3.65 ±0.61 SD vs. 4.02 ±0.62 SD, p=0.012; PPI: 48.52% ±16.33% SD vs. 57.05% ±15.65% SD, p=0.020). For Active 2 (all time points) and Active 1 (day 1 and 14), enzyme treatment resulted in nonsignificant reductions. When data for all time points were pooled, significant reductions were observed for Active 1 (p=0.005), but not Active 2 (p=0.10).<br/>Conclusion: Multiple-enzyme treatment may be a promising supplement to mechanical plaque removal.<br/>Acknowledgement of funding: The study was supported by Novozymes A/S and the Innovation Fund Denmark (grant number 9065-00244B).