NCT04404335

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

Completed Last updated 30 September 2022

What this trial tests

trial testing Crevicular fluid analysis by using ELISA testing. in Periodontal Diseases in 60 participants. Completed in 15 July 2022.

Timeline

17 May 2021

Primary endpoint
30 June 2022

15 July 2022

Quick facts

Lead sponsor	Universidad Rey Juan Carlos
Status	Completed
Study type	OBSERVATIONAL
Enrollment	60
Start date	17 May 2021
Primary completion	30 June 2022
Estimated completion	15 July 2022
Sites	1 location across Spain

Drugs / interventions tested

• Crevicular fluid analysis by using ELISA testing.

Conditions studied

• Periodontal Diseases — all drugs for Periodontal Diseases →
• Periodontitis — all drugs for Periodontitis →

Sponsor

Universidad Rey Juan Carlos — full company profile →

Who can join

18 and older, any sex, with Periodontal Diseases or Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antimicrobial peptide polymers: no escape to ESKAPE pathogens-a review.
   Mukhopadhyay S, Bharath Prasad AS, Mehta CH, Nayak UY. · · 2020 · cited 48× · PMID 32737599 · DOI 10.1007/s11274-020-02907-1
2. Bioinspired synthetic peptide-based biomaterials regenerate bone through biomimicking of extracellular matrix.
   Azadi S, Yazdanpanah MA, Afshari A, Alahdad N, et al · · 2024 · cited 11× · PMID 39670180 · DOI 10.1177/20417314241303818
3. Positive correlational shift between crevicular antimicrobial peptide LL-37, pain and periodontal status following non-surgical periodontal therapy. A pilot study.
   Madruga D, Garcia MM, Martino L, Hassan H, et al · · 2023 · cited 4× · PMID 37246231 · DOI 10.1186/s12903-023-03023-w
4. Positive correlational shift between crevicular antimicrobial peptide LL-37, pain and periodontal status following non-surgical periodontal therapy
   Madruga D, Garcia MM, Martino L, Hassan H, et al · · 2022 · DOI 10.21203/rs.3.rs-2236013/v1