A Pilot Study to Evaluate the Effect of Livionex on Reducing Plaque Accumulation and Oral Health in Children

IntroductionToothpaste is used to clean the tooth surfaces with the use of a toothbrush to improve oral health. Most toothpaste varieties include abrasives and detergents to remove dental plaque, flavoring agents mechanically, and other additives focused on addressing various oral diseases, including calculus, caries, gingival inflammation periodontitis. Fluoride is frequently added to toothpaste due to its cariostatic effects (Kanduti et al. 2016) to enhance the precipitation of calcium and phosphate in saliva to deposit minerals into demineralized tooth tissues. When swallowed, fluoride contained in toothpaste increases the incidence of enamel fluorosis. While the dental community largely considers enamel fluorosis as only of esthetic concern (McGrady et al. 2012), studies that have shown the effect of ingested fluoride on neurodevelopment have led to considerations of alternatives that are as effective as fluoride-containing toothpaste for dental caries prevention (Cheng et al. 2007). Livionex tooth gel (LTG), which proposes to disrupt oral microbiome biofilms in the mouth, is a fluoride-free oral care product. Livionex uses EDTA and methylsulfonylmethane (MSM), the combination of which has been shown to EDTA through membranes to reduce inflammation (Shoeb et al. 2018; Wang et al. 2015; Zhang et al. 2009). Recent studies have shown that biomineralization inhibitors targeting calcium uptake and carbonate accumulation significantly reduced the damage inflicted by biofilms (Wang et al. 2019). Therefore, EDTA penetration into oral biofilms may reduce the calcium bonds that stabilize the microbial populations. Bacterial biofilms produce an internal calcite mineral layer that has been shown to strengthens the biofilm structure and to protect bacteria from treatments such as antibiotics (Keren-Paz et al. 2020; Oppenheimer-Shaanan et al. 2016). Therefore, a micro-chelator, such as EDTA, carried into the oral biofilms through its attachment to MSM (methylsulfonylmethane), could inhibit microbial adherence, biofilm formation, and bacterial growth. Livionex tooth gel, therefore, is a promising alternative to alter the plaque biofilm as a means to reduce plaque bacteria and protect teeth from acid demineralization associated with these bacteria. To assess this possibility, we conducted a non-inferiority clinical trial to determine whether or Livionex tooth gel was inferior to regular fluoride-containing toothpaste