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AzTrials

PeriodontitisEMTANCT04792372

Evaluation of the Effects of Immune Cells on Periodontal Healing

A study testing Initial periodontal treatment in people with Periodontitis, run by Biruni University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Periodontitis
What is being tested?
Initial periodontal treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Feb 2021to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Biruni University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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

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
Being tested
Initial periodontal treatment
Keywords
Periodontitis, Macrophages, T-Lymphocytes, Treatment Outcome
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Initial periodontal treatmentProcedure or surgery

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

Study groups in NCT04792372
Study groupRoleWhat they receive
Periodontitis patientsOtherSingle-group receiving periodontal treatment. The data will be evaluated according to the healing potential of individuals in the group and also site-specifically.
Receives: Procedure: Initial periodontal treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Probable pocket depth (PPD)

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

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

  2. Change in Bleeding on probing (BoP)

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

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

  3. 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

    Measured: 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

  4. 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

    Measured: 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

  5. 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

    Measured: 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)

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

    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

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

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

    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

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

  3. Change in plaque index

    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

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

  4. Change in clinical attachment level (CAL)

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

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

  5. Change in biofilm microbiota

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

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

  6. Change in neutrophil-associated cytokines in saliva

    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

    Measured: baseline, 6th, 12th and 24th weeks following therapy

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

    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

    Measured: baseline, 6th, 12th and 24th weeks following therapy

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

    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)

    Measured: baseline, 6th, 12th and 24th weeks following therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study start23 Feb 2021
  3. Primary completion31 Aug 2021
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792372
Sponsor's protocol ID
TheMacPer
Acronym
EMTA
Status last verified
Aug 2022
First submitted
23 Feb 2021
Last updated
16 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Initial periodontal treatment in people with Periodontitis, run by Biruni University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Probable pocket depth (PPD) (time frame: baseline, 2nd, 6th, 12th and 24th weeks following therapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04792372.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.

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