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Completed

NCT Number: NCT04792372

Evaluation of the Effects of Immune Cells on Periodontal Healing

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Initial periodontal treatment

Procedure

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

Primary outcomes

  1. Change in Probable pocket depth (PPD)

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

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

  2. Change in Bleeding on probing (BoP)

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

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

  3. Baseline macrophage related cytokine concentrations in granulation tissue samples

    Time frame: 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

    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

  4. Baseline Th17-pathway related cytokine concentrations in granulation tissue samples

    Time frame: 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

    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

  5. Baseline density of macrophage types in granulation tissue samples

    Time frame: 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

    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

Secondary outcomes

  1. Change in macrophage and Th17-pathway related cytokine concentrations in saliva

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

    MCP-1, -2, -3, -4, MDC, MIF, MIG, MIP-1α, IP-10, IL1β, -4, -6, -10, -17A, -17F, -21, -22, -23, -25, -31, -33, IFN-γ, sCD-40L, TNF-ɑ, sCD163, TWEAK, BAFF, sST2 concentrations (pg/mL); will be correlated with the change in probable pocket depth and bleeding on probing scores

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

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

    MCP-1, -2, -3, -4, MDC, MIF, MIG, MIP-1α, IP-10, IL1β, -4, -6, -10, -17A, -17F, -21, -22, -23, -25, -31, -33, IFN-γ, sCD-40L, TNF-ɑ, sCD163, TWEAK, BAFF, sST2 concentrations (pg/mL); will be correlated with the change in probable pocket depth and bleeding on probing scores

  3. Change in plaque index

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

    Silness-Löe plaque index (scored as 0-3); full-mouth, 6 sites per tooth; will be monitored for oral health assessment during the healing period

  4. Change in clinical attachment level (CAL)

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

    distance between the cement-enamel junction and pocket base (mm); full-mouth, 6 sites per tooth; will be correlated with pocket depth reduction

  5. Change in biofilm microbiota

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

    DNA isolation and next generation sequencing: P. gingivalis, T. denticola, T. forsythia, P. intermedia, F. nucleatum and A. actinomycetemcomitans; bacterial count (log10 scale)

  6. Change in neutrophil-associated cytokines in saliva

    Time frame: baseline, 6th, 12th and 24th weeks following therapy

    MMP-2, MMP-7, MMP-8, active MMP-8, MMP-9, MMP-13, TIMP, myeloperoxidase, PMN elastase (IFMA and ELISA methods) concentrations (pg/mL) in saliva

  7. Change in neutrophil-associated cytokines in and oral rinse

    Time frame: baseline, 6th, 12th and 24th weeks following therapy

    MMP-2, MMP-7, MMP-8, active MMP-8, MMP-9, MMP-13, TIMP, myeloperoxidase, PMN elastase (IFMA and ELISA methods) concentrations (pg/mL) in oral rinse samples

  8. active MMP-8 point-of-care test results in oral rinse

    Time frame: baseline, 6th, 12th and 24th weeks following therapy

    Dichotomous aMMP-8 test results in oral rinse samples (according to the manufacturer, a concentration below 20 ng/mL gives a negative test result, otherwise positive - Periosafe (R) Dentognostics GmHb, Jena, Germany)

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey
  • University of Turku

Registry information

Official study title

Evaluation of the Effects of Initial Macrophage and Th17 Cell Activities on the Healing Following Periodontal Phase I Therapy

Acronym: EMTA

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 11, 2021
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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