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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Changes in salivary TNF-α levels.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in salivary TNF-α levels.
时间窗: T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.
Differences between TNF-α levels before and after the use of the assigned toothpaste for intervention and for control group.
Changes in salivary IL-1ß levels.
时间窗: T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.
Differences between IL-1ß levels before and after the use of the assigned toothpaste for intervention and for control group.
Changes in salivary IL-4 levels.
时间窗: T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.
Differences between IL-4 levels before and after the use of the assigned toothpaste for intervention and for control group.
Comparison of changes in IL-1ß levels between intervention and control groups.
时间窗: T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.
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.
Comparison of changes in IL-4 levels between intervention and control groups.
时间窗: T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.
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.
Comparison of changes in TNF-α levels between intervention and control groups.
时间窗: T0 refers to the time at which baseline measurements are taken. T1 refers to 30 days.
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.
次要结局
- 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.)
- Changes in subgingival total bacterial load.(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.)