The Role of Anti-inflammatory Cytokines and Antimicrobial Peptide LL-37 Biomarkers in the Treatment of Periodontal Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- LL-37 in crevicular fluid in healthy/periodontal patients.
研究概览
简要总结
Periodontal disease is an infectious pathology that consists of the destruction of the gums and supporting structures around the teeth. There are several mechanisms involved in this process. In healthy conditions there is a balance between the bacteria present in the gums and the defence mechanisms of the host to fight the disease. One of the substances involved in favouring this protective mechanism is a peptide called LL-37.
The aim of this study is to find out more about the rol of this peptide during this process by using a non invasive method of analysis consisting of analysing some samples of the fluid existing between the gums and the teeth.
This clinical study will take place at the University Clinic at the University Rey Juan Carlos, Alcorcon (Madrid), Spain. Patients that attend the clinic suffering from gum disease will be offered the possibility to participate in this study. A full questionnaire indicating the risks and benefits of participating in the study as well as the management of confidential personal data will be discussed with the participants in full detail. Full consent will be sought before commencing the study.
Firstly, all participants will receive a through periodontal (gum) examination to assess if they suffer from periodontal disease and to what extent (severity). Based on this preliminary data, patients will be classified in different categories.
Patients will be divided in two groups:
-
30 Healthy patients (no signs of periodontitis)
-
30 Periodontal patients (subdivided in 2 groups of 30, depending of the severity of their disease:
-
15 patients with Stage I-II periodontitis (mild/moderate)
-
15 patients with Stage III-IV periodontitis (severe).
The intervention will consist on taking samples of crevicular fluid (the fluid found in the space between the gum and the root of the tooth) to quantify the presence of LL-37 as well as IL-4, IL-6, IL-10, which seems to be associated with the defence mechanisms (immunity) of the host against periodontal disease. These samples will be analysed in the laboratory by using some specific procedure called ELISA.
All patients from the test group will receive a basic course of periodontal treatment (root scale and polish), which is intended to remove the bacteria causing the disease from the space between the gums and the roots (periodontal pocket). Samples of crevicular fluid will be obtained before commencing the treatment. After 4-6 weeks, a new periodontal examination will take place to assess if there is an improvement of the condition and also to quantify the levels of LL-37, IL-4, IL-6, IL-10.
The findings of this study will help to understand the role of this peptide in the defence mechanism of the host against periodontal disease. This could ultimately serve to develop new therapies that could include the use of this peptide in addition to the routine periodontal treatment prescribed to improve the healing conditions of the patient against periodontal disease.
详细描述
'The role of anti-inflammatory cytokines and antimicrobial peptide LL-37 biomarkers in the treatment of periodontal disease.
- Introduction
Periodontal disease is an infectious process that consists of the destruction of the supporting anatomical structures of the tooth, as a consequence of the inflammatory response to the periopathogenic activity of the subgingival bacterial plaque, which leads to an innate, inflammatory and adaptative immune response.
The clinical manifestation of the disease depends of host and environmental factors as well as the specific microbiological agent involved. The interrelation amongst bacteria and the immunodefence mechanisms of the host constitute the base of the immunopathological mechanisms that lead to the disease. In healthy conditions, there is a balance between the activity of the periodontal microbiota and the host immune response.
In the innate defence system of the oral cavity there are several antimicrobial peptides involved, being one of them, the human cathelicidin LL-37.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
LL-37 in crevicular fluid in healthy/periodontal patients.
时间窗: At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group
Crevicular fluid samples will also be obtained following the manufacturers protocol using perio papers (Periopaper, Applied Biosystems, Inc, Foster City, CA). Samples will be stored at -80 C at the laboratory of Departamento de Epidemiología y Salud Pública, Edificio Departamental I, Fundación Clínica Universitaria, URJC (Alcorcon). Once all samples are obtained, appropriate transport will be arranged to the Department of Natural Sciences, Biomedical Sciences, Hendon Campus, Middlesex University of London. There ELISA analysis of all samples will be performed by using a specific ELISA kit commercially available for human LL-37 (HyCult Biotechnology, Uden, the Netherlands).
次要结局
- Periodontal parameters(At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group)
- Plaque index (PI)(At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group)
- Probing depth (PD)(At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group)
- Clinical attachment level (CAL)(At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group)
- Blood on probing (BOP)(At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group)
研究者
David Madruga-Gonzalez
Associate Professor
Universidad Rey Juan Carlos