Oral Dysbiosis Clinical Trial
Official title:
Stop Oral Dysbiosis. Study on the Effects of a Toothpaste in the Inflammatory Profile, Microbiome and Other Oral Dysbiosis Parameters: A Controlled, Randomized, Double-blind Study. This Study is Part of the Stop Dysbiosis Project
Dysbiosis is a situation in which the normal function of an ecological net is altered. In health there is a cross talk between the host and the microbiota in order to maintain and promote a state of eubiosis. In dysbiosis a state of inflammation, a loss of hydration, a change in pH, a loss of the barrier function are all allies of key pathogens that work against the host. Stop dysbiosis is a bigger multibranch project focussed on different aspects of clinical dysbiosis including this prospective interventional double blind randomised clinical trial. Stop dysbiosis comprises further clinical studies in several areas such as oral dysbiosis, skin dysbiosis, vaginal dysbiosis and cancer dysbiosis, between others. One of the most common dysbiosis of the mouth is periodontal and mucosa dysbiosis that courses with inflammation of the gingiva (gingivitis). This inflammation induces some enzymes that in a later stage destroy connective tissue. The current study beeing presented now is focussed to research the effect of a composition with Saliactive ® topically delivered to the oral cavity vehiculized in an everyday toothpaste (YOTUEL® microbiome toothpaste) in a group of patients with oral dysbiosis.
Oral microbiota is formed by diverse bacteria, archea, protozoos, yeast and funghi. More than 700 species of bacteria have been identified in the mouth. These bacteria live in equilibria in conditions of health. When equilibria is lost, due to changes in microbiota or changes in the ecosystem, dysbiosis appears. Periodontal dysbiosis is the consequence of the accumulation of plaque and the increase of gram negative species capable of releasing virulence factors that maintain inflammation and bleeding that maintain the ecosystem in a disease promoting status. Oral hygiene is a daily personal protocol effective means of delivery different substances to the tissues of the oral cavity. Toothpaste, mouthrinse, topical gels, lozenges and sprays are the most common presentations used in the oral cavity. The standard of care in the oral compound is toothpaste used 2-3 times a day. The toothpaste that is going to be tested in the study does not contain any anymicrobial agent and includes an olive product, betaine and xylitol. Its efficacy will be tested measuring the inflammatory profile that includes plaque index and bleeding index, the microbiota population by genetic sequenciation of the ADNr 16s, the salivary flow, the colour ot teeth and the nitrates/nitrites ratio at baseline, after 2 months and 4 months using the product. Two controls will be also analysed to compare results, one with the same composition but without the 3 ingredients olive product, betaine and xylitol, and one product marketed as a toothpaste for gingivitis with an antibacterial ingredient. Assignation of the 100 subjects will be randomized and the products are blind for the subjects and the researcher. ;