Introduction:

Correct oral homeostasis, associated with good oral hygiene, is necessary to decrease the bacterial load of cariogenic pathogens and the inhibition of periodontal pathogens, as well as to modulate inflammatory response. The objective of this study is to evaluate the effects of a toothpaste for the protection of the oral microbiome, in patients treated at the Hospital Odontológico Universidad de Barcelona (HOUB).

Material and methods:

Randomized double-blind clinical trial with placebo in patients treated at HOUB. In the Study Group [SG] a specific toothpaste [PDE] is used, which contains as active ingredients extra virgin olive oil, betaine and xylitol, as well as sodium monofluorophosphate (1,450 ppm F-) + Excipients. In the control group [CG] a placebo paste without active ingredients is used. All patients underwent an oral examination with periodontal clinical parameters, pH measurement, salivary flow (stimulated and unstimulated), cytokine count (TNF, IL-1 and IL-4.) and total bacterial load by qPCR16S at the beginning and one month after treatment.

Results:

A total of 26 patients were included, 17 women and 9 men, with a mean age of 48.76 years. The pH level remained stable between the beginning and the end of the study in both groups, with no differences between them. 11 patients felt their mouth was in a better state, 7 of which were test and 4 control (p=0.1); 10 patients felt their mouth was in the same as before the treatment; and only one (placebo) felt it was worse. For the 16S analysis, only 10 patients were analyzed: 5 SG and 5 CG. In the test group, the total bacterial load decreased in all cases, and in the control group, it decreased in 4 and increased in 1. Among the 16 patients whose cytokines were analyzed, no statistically significant differences were observed.

Conclusions:

The tested product is well accepted by patients and reduces both oral inflammation and the global bacterial load, without statistically significant results. A study with a larger sample would be advisable to verify if the trend of reduction in the load of pathogens and reduction of associated inflammation is significant.

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