CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Crevicular fluid analysis by using ELISA testing.other
Likely dose
Not stated in record
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Search/NCT04404335
NCT04404335N/ACompleted

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

Universidad Rey Juan Carlos·observational·Posted May 27, 2020·Updated Sep 30, 2022

In Brief

An observational study evaluating Crevicular fluid analysis by using ELISA testing. for Periodontal Diseases and Periodontitis. Completed, enrolled 60 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 27, 2020
Enrollment StartMay 17, 2021
Primary CompletionJun 30, 2022
Study CompletionJul 15, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.1 years ago

Interventions

Crevicular fluid analysis by using ELISA testing.other

Samples of crevicular fluid (fluid existing in the space between the gums and the roots of the teeth) will be obtained from healthy and periodontal patients. In periodontal patients, samples will be taken before and after receiving a routine course of periodontal treatment (root scale and polish) to assess the levels of a peptide called LL-37 and inflammatory cytokines (IL-4, IL-6, IL-10): Samples will then be analysed using laboratory procedures (ELISA)