Clinical trial NCT04792372: Evaluation of the Effects of Immune Cells on Periodontal Healing
Official title: Evaluation of the Effects of Initial Macrophage and Th17 Cell Activities on the Healing Following Periodontal Phase I Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Periodontitis
Macrophages
T-Lymphocytes
Treatment Outcome
Lead sponsor: Biruni University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
name: University of Turku
First posted: 2021-03-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Probable pocket depth (PPD)
timeFrame: baseline, 2nd, 6th, 12th and 24th weeks following therapy
measure: Change in Bleeding on probing (BoP)
timeFrame: baseline, 2nd, 6th, 12th and 24th weeks following therapy
measure: Baseline macrophage related cytokine concentrations in granulation tissue samples
timeFrame: 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
measure: Baseline Th17-pathway related cytokine concentrations in granulation tissue samples
timeFrame: 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
measure: Baseline density of macrophage types in granulation tissue samples
timeFrame: 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:
measure: Change in macrophage and Th17-pathway related cytokine concentrations in saliva
timeFrame: baseline, 2nd, 6th, 12th and 24th weeks following therapy; immunohistochemical analysis will be carried out through study completion, 6-9 months
measure: Change in macrophage and Th17-pathway related cytokine concentrations in gingival crevicular fluid (GCF)
timeFrame: baseline, 2nd, 6th, 12th and 24th weeks following therapy; immunohistochemical analysis will be carried out when through study completion, 6-9 months
measure: Change in plaque index
timeFrame: baseline, 2nd, 6th, 12th and 24th weeks following therapy
measure: Change in clinical attachment level (CAL)
timeFrame: baseline, 2nd, 6th, 12th and 24th weeks following therapy
measure: Change in biofilm microbiota
timeFrame: baseline, 2nd, 6th, 12th and 24th weeks following therapy; microbiological analysis will be carried out through clinical phase completion, 6-9 months
measure: Change in neutrophil-associated cytokines in saliva
timeFrame: baseline, 6th, 12th and 24th weeks following therapy
measure: Change in neutrophil-associated cytokines in and oral rinse
timeFrame: baseline, 6th, 12th and 24th weeks following therapy
measure: active MMP-8 point-of-care test results in oral rinse
timeFrame: baseline, 6th, 12th and 24th weeks following therapy
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University
name: Mustafa YILMAZ
role: PRINCIPAL_INVESTIGATOR
References: