Evaluation of the Effects of Immune Cells on Periodontal Healing (EMTA)

Biruni University

Status: Completed

Conditions: Periodontitis

Treatments: Procedure: Initial periodontal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04792372

TheMacPer

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• moderate to severe periodontitis
• having at least two pockets ≥ 6 mm
• systemic healthy

Exclusion criteria

• received periodontal treatment prior to study
• received antibiotic or antiinflammatory drugs in the last 6 months
• pregnant or in lactation

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Periodontitis patients

Other group

Description:

Single-group receiving periodontal treatment. The data will be evaluated according to the healing potential of individuals in the group and also site-specifically.

Treatment:

Procedure: Initial periodontal treatment