Evaluation of the Effects of Immune Cells on Periodontal Healing

NCT ID: NCT04792372

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Healing will be monitored of periodontitis patients who receive conventional initial treatment. The patients will be grouped according to their healing capacity at the end of the study.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Periodontitis patients

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

Group Type OTHER

Initial periodontal treatment

Intervention Type PROCEDURE

Conventional periodontal treatment (scaling and root debridement) will be conducted

Interventions

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Initial periodontal treatment

Conventional periodontal treatment (scaling and root debridement) will be conducted

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role collaborator

Biruni University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa YILMAZ

Asst Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mustafa YILMAZ

Role: PRINCIPAL_INVESTIGATOR

Biruni University

Locations

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Biruni University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TheMacPer

Identifier Type: -

Identifier Source: org_study_id

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