MedTrace Logo

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

NCT06786910 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-03-10

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Toothpaste with olive oil, trimethylglycine and xylitol

Composition comprising olive oil, trimethylglycine and xylitol, formulated as a toothpaste to be delivered topically onto the oral cavity 3 times a day during 1 month.

OTHER

Toothpaste without olive oil, trimethylglycine nor xylitol

Composition without olive oil, without trimethylglycine and without xylitol, formulated as a toothpaste to be delivered topically onto the oral cavity 3 times a day during 1 month.

Sponsors & Collaborators

  • University of Barcelona

    collaborator OTHER

  • Mucosa Innovations, S.L.

    lead INDUSTRY

Principal Investigators

  • José López-López · Barcelona University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2022-09-15
Completion
2022-09-15

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06786910 on ClinicalTrials.gov