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Completed

NCT Number: NCT03225950

Interaction Between Immune Cells and Bacteria Associated With Periodontitis

This study evaluates the interaction between host immune cells and bacteria associated with periodontitis. It comprises biological material from donors with and without periodontal disease. Specifically, we collect a spit and blood sample to conduct in vitro stimulations and measurements of selected parameters related to periodontitis to clarify obscure areas in the immunologic pathogenesis of this disease.

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Key information

About this study

Periodontitis is a prevalent, multifactorial inflammatory disease characterized by the interaction between microorganisms organized in biofilms on tooth surfaces and host immune cells, leading to an inflammatory destruction of the tooth-supporting tissues and - if left untreated - eventually tooth loss. Periodontitis affects up to 50% of the population in the United States of America, and is classified in an aggressive and a chronic form depending on genetic factors, age of onset, speed and severity of attachment loss.

The onset of periodontitis is caused by an immunologic imbalance between host immune cells and residing microorganisms in subgingival pockets. The host immune cells are capable of enhancing both a protective and a destructive inflammatory response towards the microorganisms through the release of inflammatory mediators e.i. proinflammatory and antiinflammatory cytokines.

The role of antibodies in periodontitis is also unclear. Some studies show an excessive antibody level against bacteria associated with periodontitis e.g. Porphyromonas gingivalis (P.g.).

In general, this study contributes to a profound understanding of the host immune cells role in the onset and pathogenesis of periodontitis by comparing healthy versus diseased donors immunologic responses toward pathogene and apathogene microorganisms and their genetic background.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for chronic periodontitis donors:

  • 50-60 years of age.
  • Interproximal attachment loss at minimum 3 teeth besides molars and incisors.
  • Clinical attachment loss at minimum 10 sites identified by bleeding and pus upon probing.
  • Visible radiographic bone loss.
  • Medically healthy donors.

Inclusion criteria

for aggressive periodontitis donors:

  • 19-40 years of age.
  • Interproximal attachment loss at minimum 3 teeth besides molars and incisors.
  • Clinical attachment loss at minimum 10 sites identified by bleeding and pus upon probing.
  • Visible radiographic bone loss.
  • Medically healthy donors.

Inclusion criteria

for healthy donors: (age: 19-40 years; 50-60 years)

  • No sign of inflammatory conditions or other general systemic diseases.
  • Medically healthy donors.

Exclusion criteria

for all groups:

  • Pregnant and breastfeeding.
  • Antibiotic treatment within 6 months.
  • Suffer from periodontal manifestations caused by systemic diseases e.i. genetic diseases, haematologic anomalies or syndromes.

Treatment and study plan

In vitro stimulation of blood with periodontitis-associated- and control bacteria

Other

Peripheral mononuclear blood cells are stimulated with periodontitis-associated- and control bacteria to measure the amount of positive cytokine-producing cells.

Anti-CCP- and anti-P.g.-antibodies titers

Diagnostic Test

Anitbody titers will be measured in saliva and serum samples.

Analysis of selected single nucleotide polymorphisms (SNPs)

Genetic

DNA obtained from saliva samples will be used to determine the genotype of the participants for selected SNPs.

periodontitis-associated bacteria presence

Diagnostic Test

Determination of the presence of periodontitis-associated bacteria e.i. Porphyromonas gingivalis in saliva and blood samples.

Primary outcomes

  1. periodontitis-associated- and control bacterial stimulation of host immune cells.

    Time frame: Aug. 2020

    Identification and determination of the amount of cytokine-producing immune cells when stimulated with bacteria associated with periodontitis including pro- and antiinflammatory cytokines.

    Genuses: Porphyromonas, Prevotella, Eikenella, Aggregatibacter, Actinomyces, Lactobacillus, Bifidobacterium, Rothia.

  2. Anti-cyclic citrullinated peptides (anti-CCP) antibodies titers.

    Time frame: Aug. 2020

    Determination of the prevalence of anti-CCP-positive periodontitis patients through measure of anti-CCP antibody titers in serum samples and correlation with the level of antibodies to P. gingivalis, and to the abundancy of the bacterium in saliva.

  3. P. gingivalis presence and related antibodies.

    Time frame: Aug. 2020

    Determination of P. gingivalis presence in saliva and serum samples through RT-qPCR and determination of the level of antibodies towards the bacterium using in-house Luminex-based technology.

  4. Single nucleotide polymorphism (SNP) analysis.

    Time frame: Aug. 2020

    Investigation of the potential association between periodontitis and selected polymorphisms in the PADI genes using multiplex bead-based SNP assays with the Luminex technology.

Secondary outcomes

  1. Cytokine profile in saliva.

    Time frame: Aug. 2020

    Determination of the cytokine profile in saliva samples from subject with periodontitis and healthy controls with Luminex based technology.

  2. Presence of other periodontal bacteria.

    Time frame: Aug. 2020

    Determination of the presence of other periodontal bacteria through RT-qPCR assays.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Copenhagen University Hospital, Denmark

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Jul 21, 2017
Registry last updated
Mar 24, 2020

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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