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 | Completed

• 1 other identifier: 03-2022
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Interleukin-1beta; TNF-α; Cytokine Levels; BMI; Chronic Inflammatory Diseases; Dysbiosis; Overweight (BMI > 25)

Keywords

Inflammation; Cytokines; IL-1ß; TNF-α; BMI; Overweight; Dysbiosis; Chronic inflammatory diseases; Pro-inflammatory cytokines; olive oil, trimethylglycine and xylitol

Outcome Measures

Primary Outcomes (6)

• Changes in salivary IL-1ß levels.

  Differences between IL-1ß levels before and after the use of the assigned toothpaste for intervention and for control group.

  T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.

• Changes in salivary TNF-α levels.

  Differences between TNF-α levels before and after the use of the assigned toothpaste for intervention and for control group.

  T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.

• Changes in salivary IL-4 levels.

  Differences between IL-4 levels before and after the use of the assigned toothpaste for intervention and for control group.

  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.

  Each group will show a IL-1ß level at baseline and a IL-1ß level after 1 month use of the assigned toothpaste. Sense and magnitude of the changes observed for the intervention group will be compared with the changes observed for the control group.

  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.

  Each group will show a TNF-α level at baseline and a TNF-α level after the use of the assigned toothpaste. Sense and magnitude of the changes observed for the intervention group will be compared with the changes observed for the control group.

  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.

  Each group will show a IL-4 level at baseline and a IL-4 level after the use of the assigned toothpaste. Sense and magnitude of the changes observed for the intervention group will be compared with the changes observed for the control group.

  T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.

Secondary Outcomes (3)

• Changes in subgingival total bacterial load.

  T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.

• Clinically assessed parameters at baseline and after the use of the assigned toothpaste.

  T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.

• Comparison of changes in cytokine levels, due to the use of the assigned toothpaste, between intervention and control group in patients with BMI>25.

  T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.

Other Outcomes (1)

• Patient reported outcome measures of flavour, satisfaction, acceptance, preference and recommendation to use with the use of a visual analogue scale.

  T1 refers to 30 days.

Study Arms (2)

Intervention group

EXPERIMENTAL

Toothpaste with olive oil, trimethylglycine and xylitol.

Other: Toothpaste with olive oil, trimethylglycine and xylitol

Control group

PLACEBO COMPARATOR

Toothpaste with identical flavour and aspect that experimental toothpaste but without olive oil, without trimethylglycine and without xylitol.

Other: Toothpaste without olive oil, trimethylglycine nor xylitol

Interventions

Toothpaste with olive oil, trimethylglycine and xylitol OTHER

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.

Intervention group

Toothpaste without olive oil, trimethylglycine nor xylitol OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients attending to a routinary control visit at the University of Barcelona Dental Hospital (HOUB) over 18 years of age;
• who give their informed consent to participate in the study;
• do not have associated medical pathology in ASA III and IV.

You may not qualify if:

• patients who do not wish to participate in the study;
• allergic to the components of the toothpaste;
• on active antibiotic treatment or having received antibiotic treatment within the past seven days;
• patients presenting pain or acute infections will be excluded as well as ASA III and IV; -
• patients with diabetes and BMI\>40 and severe periodontitis will be excluded.

Sponsors & Collaborators

• Mucosa Innovations, S.L.: lead
• University of Barcelona: collaborator

Study Sites (1)

University of Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (2)

• Dinarello CA, van der Meer JW. Treating inflammation by blocking interleukin-1 in humans. Semin Immunol. 2013 Dec 15;25(6):469-84. doi: 10.1016/j.smim.2013.10.008. Epub 2013 Nov 23.

  PMID: 24275598 BACKGROUND

• Hajishengallis G, Chavakis T. Inflammatory memory and comorbidities. Clin Transl Med. 2022 Jul;12(7):e984. doi: 10.1002/ctm2.984. No abstract available.

  PMID: 35839318 BACKGROUND

MeSH Terms

Conditions

Inflammation; Dysbiosis; Overweight

Interventions

Toothpastes; Olive Oil; Betaine; Xylitol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Sugar Alcohols; Alcohols; Carbohydrates

Study Officials

• José López-López

  Barcelona University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two toothpastes will be included in the study; one with the novel composition including olive oil, trimethylglycine and xylitol, and one without olive oil, trimethylglycine and xylitol. Both toothpastes, intervention and control, will be identical in aspect and flavour. Subjects are randomnly assigned: Researchers and participants will be blinded.

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 22, 2025
• Study Start: June 13, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

ES (1)