Evaluation of the Effects of Immune Cells on Periodontal Healing

NCT04792372 | Completed

• 1 other identifier: TheMacPer
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis

Keywords

Periodontitis; Macrophages; T-Lymphocytes; Treatment Outcome

Outcome Measures

Primary Outcomes (5)

• Change in Probable pocket depth (PPD)

  distance between the gingival margin and pocket base (mm); full-mouth scores, 6 sites per tooth

  baseline, 2nd, 6th, 12th and 24th weeks following therapy

• Change in Bleeding on probing (BoP)

  visual inspection, dichotomous; full-mouth, 6 sites per tooth; change in positive sites %

  baseline, 2nd, 6th, 12th and 24th weeks following therapy

• Baseline macrophage related cytokine concentrations in granulation tissue samples

  two pockets (≥6mm; BoP+) of each individual; Luminex: monocyte chemoattractant protein (MCP)-1, -2, -3, -4; macrophage derived chemokine (MDC); macrophage inhibitory factor (MIF), monokine induced by gamma interferon (MIG), macrophage inflammatory protein (MIP)-1α, interferon γ-induced protein (IP)-10, CD163, TWEAK, BAFF concentrations (pg/mL); each will be correlated with the change in probable pocket depth and bleeding on probing scores

  Samples will be obtained during the intervention and will be kept in -80oC until immunohistochemical analysis which will be carried out through study completion, 6-9 months

• Baseline Th17-pathway related cytokine concentrations in granulation tissue samples

  two pockets (≥6mm; BoP+) of each individual; Luminex: Interleukin (IL)-1β, -4, -6, -10, -17A, -17F, -21, -22, -23, -25, -31, -33, interferon (IFN)-γ, soluble cluster of differentiation 40 ligand (sCD-40L), tumor necrosis factor (TNF)-ɑ concentrations (pg/mL); each will be correlated with the change in probable pocket depth and bleeding on probing scores

  Samples will be obtained during the intervention and will be kept in -80oC until immunohistochemical analysis which will be carried out through study completion, 6-9 months

• Baseline density of macrophage types in granulation tissue samples

  two pockets (≥6mm; BoP+) from each individual; Immunoblot analysis: cluster of differentiation(CD)68 and CD163; cell number / optic field (cells/mm2); each will be correlated with the change in probable pocket depth and bleeding on probing scores

  Samples will be obtained during the intervention and will be kept in -80oC until immunohistochemical analysis which will be carried out through study completion, 6-9 months

Secondary Outcomes (8)

• Change in macrophage and Th17-pathway related cytokine concentrations in saliva

  baseline, 2nd, 6th, 12th and 24th weeks following therapy; immunohistochemical analysis will be carried out through study completion, 6-9 months

• Change in macrophage and Th17-pathway related cytokine concentrations in gingival crevicular fluid (GCF)

  baseline, 2nd, 6th, 12th and 24th weeks following therapy; immunohistochemical analysis will be carried out when through study completion, 6-9 months

• Change in plaque index

  baseline, 2nd, 6th, 12th and 24th weeks following therapy

• Change in clinical attachment level (CAL)

  baseline, 2nd, 6th, 12th and 24th weeks following therapy

• Change in biofilm microbiota

  baseline, 2nd, 6th, 12th and 24th weeks following therapy; microbiological analysis will be carried out through clinical phase completion, 6-9 months

Study Arms (1)

Periodontitis patients

OTHER

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

Procedure: Initial periodontal treatment

Interventions

Initial periodontal treatment PROCEDURE

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

Periodontitis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Biruni University: lead
• The Scientific and Technological Research Council of Turkey: collaborator
• University of Turku: collaborator

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mustafa YILMAZ

  Biruni University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 11, 2021
• Study Start: February 23, 2021
• Primary Completion: August 31, 2021
• Study Completion: June 30, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)