Effect on Cytokines IL-1ß, TNF-α, IL-4, and Total Bacterial Load of a Composition Comprising Olive Oil, Trimethylglycine and Xylitol Delivered as a Toothpaste
brief summary
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.
detailed description
Barrier integrity plays a pivotal role in the homeostasis of the innate immune system. These barriers, their cells and networks, when intact and inhabited with an eubiotic microbiome, regulate immunity and inflammation, keeping the body in a state of homeostasis and balance with the outcome of health.
External pressure on mucosa and skin barriers from foreign substances and environmental circumstances, provides a changing ground for pro-inflammatory cytokine expression leading to what is known today as metabolic infection and systemic inflammation. Maintained pressure can exceed immune system control mechanisms, resulting in an ungoverned release of a variety of pro-inflammatory cytokines such as IL-1ß and TNF-α, that will further contribute to barrier breakage and to a state of immune dysregulation and inflammation. On the contrary, IL-4 has been ascribed both anti-inflammatory and pro-inflammatory properties.
Periodontal inflammation, the second most frequent contributor to systemic inflammatory load behind obesity, is an important factor upregulating salivary pro-inflammatory cytokines, and offers a practical model to address the complex crosstalk between inflammation and chronic inflammatory diseases.
STUDY DESIGN The current study will be a randomized controlled trial in periodontally healthy patients scheduled for a routine visit at the University of Barcelona (UB), Dental Hospital Barcelona University (HOUB), Bellvitge Campus.
Randomization and masking Patients will be randomly assigned by means of a random assignment sequence generated using Microsoft Office Excel 2019 (Microsoft Corporation, Washington, USA, 2013). A 1:1 distribution will be used to assign participants to either the Intervention Group (IG) or the Control Group (CG).
Intervention group will use an experimental toothpaste containing a novel composition comprising olive oil, trimethylglycine and xylitol. Control group will use a placebo toothpaste. Excipients will be common to both groups. All products will be packaged in white tubes with a label that will identify the number of patient. The product information allocated to each patient will be placed in a sealed envelope, exhibiting exclusively patient allocation number to maintain the integrity of the blinding process. Both, participants and operators will be masked to assignment.
Interventions Participants will be recruited during a routine visit to the University of Barcelona Dental Hospital. All participants from both groups will be attended at the dental clinic at the beginning and at the end of the study. During first visit baseline data will be recovered. Final visit will take place after one month for final data collection.
official title
Effect on Cytokines IL-1ß, TNF-α, IL-4 and Total Bacterial Load of an Oral Topical Composition Comprising Olive Oil, Trymethylglycine and Xylitol: a Randomized Controlled Double-blind Clinical Trial Part of the Stop Dysbiosis Project (SDP)