NCT04792372: EMTA

Evaluation of the Effects of Immune Cells on Periodontal Healing

Completed NA Last updated 16 August 2022

What this trial tests

NA trial testing Initial periodontal treatment in Periodontitis in 52 participants. Completed in 30 June 2022.

Timeline

23 February 2021

Primary endpoint
31 August 2021

30 June 2022

Quick facts

Lead sponsor	Biruni University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	52
Start date	23 February 2021
Primary completion	31 August 2021
Estimated completion	30 June 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Initial periodontal treatment

Conditions studied

• Periodontitis — all drugs for Periodontitis →

Sponsor

Biruni University

Who can join

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

Sponsor's own description

Periodontitis is an inflammatory disease with an infectious character, where, as the result of the host response to a dysbiotic microflora, attachment and bone loss occur. The host response and the healing period following the treatment differs among individuals, but the reason behind is not fully understood. The macrophages and T cells play an important role in the immune response and in the pathogenesis of periodontal diseases, but their role in the healing following periodontal therapy is not known. In this study, we aim to reveal the effects of initial macrophage and T cell activities in the gingival tissue on the differences of the response to phase I periodontal treatment.

42 individuals will be included in the study. Granulation tissue samples will be collected from two separate deep pockets of each individual, initially. At the same session, full-mouth scaling and root debridement will be conducted. Saliva, subgingival biofilm and gingival crevicular fluid (GCF) samples will also be collected, initially, and at the 2nd, 6th, 12th and 24th weeks. At the same appointments, periodontal parameters will be recorded. When the clinical procedures are concluded, the samples will be sent to Turku University with dry ice. Tissue and GCF concentrations of related cytokines will be analyzed with Luminex. The density of macrophage types will be defined by immunoblot analysis of related markers. Macrophage subpopulations in tissues will be specified by proteomics. Likewise, quantities of periodontal pathogens will be evaluated with DNA isolation and next generation sequencing.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Baseline interleukin-10, CD163, and tumor necrosis factor-like weak inducer of apoptosis (TWEAK) gingival tissue levels in relation to clinical periodontal treatment outcomes: A 12-week follow-up study.
   Yilmaz M, Demir E, Gürsoy M, Firatli E, et al · · 2023 · cited 5× · PMID 35819128 · DOI 10.1002/jper.22-0242