The Role of Anti-inflammatory Cytokines and Antimicrobial Peptide LL-37 Biomarkers in the Treatment of Periodontal Disease.

Status

Completed

Phase

Phase not stated

Enrollment

60 participants (actual)

Sponsor

Universidad Rey Juan Carlos · Other

Design

Not stated

Countries

1 country

Spain

Start

17 May 2021

Primary completion

30 Jun 2022

Completion

15 Jul 2022

First posted

27 May 2020

Last update posted

30 Sept 2022

Conditions

Periodontal Diseases · Periodontitis

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.

• Other

  Healthy (control group)

  This group will include a total of 30 patients free of periodontitis Samples of crevicular fluid to quantity levels of antimicrobial peptide LL-37 will be taken at baseline ELISA analysis of all samples will be performed by using a specific ELISA kit commercially available for human LL-37 and also IL-4, IL-6 and IL-10

• Other

  Periodontitis (test group)

  30 Periodontal patients (subdivided in 2 groups of 15, depending of the severity of their disease): * 15 patients with Stage I-II periodontitis (mild/moderate) * 15 patients with Stage III-IV periodontitis (severe). Two sets of samples of crevicular fluid will be obtained before and after receiving a course of routine basic periodontal treatment (root scaling and planing). A reevaluation visit to re-assess clinical periodontal parameters will take place at 4-6 weeks after treatment. New samples of crevicular fluid will then be taken at this stage to compare the level of LL-37 before and after the treatment. 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).

1. LL-37 in crevicular fluid in healthy/periodontal patients.

   Time frame · At baseline for healthy (control) and periodontal (test) groups and at 4-6 weeks after treatment for test group

   Registry description

   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).