The goal of this clinical trial is to learn if a novel composition comprising olive oil, trimethylglycine and xylitol, affects salivary levels of IL-1ß, TNF-α and IL-4 in a group of periodontally healthy, normal and overweight/pre-obese patients. The main question it aims to answer is if 1 month use of a composition under patent protection (patent pending, publication no. EP 4110321 A1 and US 2023/041103 A1) is able to reduce pro-inflammatory cytokines. The inflammatory background common to chronic inflammatory conditions is receiving the focus of research as it is thought to be originated in the overexpression of pro-inflammatory cytokines mainly IL-1ß and TNF-α considered today the link between the high burden of comorbidities associated to inflammation. Researchers will compare the novel composition to a placebo (placebo toothpaste with same colour and flavour) to see if pro-inflammatory cytokine levels are reduced. In a randomised double-blind controlled trial participants will be alleatorized to one of two groups, intervention or control. The composition will be delivered via toothpaste onto the oral mucosa in the intervention group while the control group will use a placebo toothpaste with the same characteristics but lacking the composition. All participants will be instructed to brush their teeth 3 times a day for one month without having had a dental cleaning before the start of the study.
Age range
18 Years
Sex
ALL
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Changes in salivary IL-1ß levels.
Timeframe: T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.
Changes in salivary TNF-α levels.
Timeframe: T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.
Changes in salivary IL-4 levels.
Timeframe: T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.
Comparison of changes in IL-1ß levels between intervention and control groups.
Timeframe: T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.
Comparison of changes in TNF-α levels between intervention and control groups.
Timeframe: T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.
Comparison of changes in IL-4 levels between intervention and control groups.
Timeframe: T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.