Interaction Between Immune Cells and Bacteria Associated With Periodontitis

Completed

• Conditions: Dysbiosis; Aggressive Periodontitis; Periodontal Pocket; Inflammation; Inflammation Gum; Generalized Chronic Periodontitis; Immunologic Disease; Chronic Periodontitis; Periodontal Diseases; Periodontitis
• Interventions: Other: In vitro stimulation of blood with periodontitis-associated- and control bacteria; Diagnostic Test: Anti-CCP- and anti-P.g.-antibodies titers; Genetic: Analysis of selected single nucleotide polymorphisms (SNPs); Diagnostic Test: periodontitis-associated bacteria presence

• Registration Number: NCT03225950
• Lead Sponsor: University of Copenhagen

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Status Verified: 2018-10
• Primary Completion: 2018-10-12
• Study Completion: 2020-03-23
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic periodontitis donors	Analysis of selected single nucleotide polymorphisms (SNPs)	* Donors are medically healthy. * Slow to moderate attachment loss and bone destruction. * Good correlation between etiological factors and serverity of attachment loss.
Chronic periodontitis donors	In vitro stimulation of blood with periodontitis-associated- and control bacteria	* Donors are medically healthy. * Slow to moderate attachment loss and bone destruction. * Good correlation between etiological factors and serverity of attachment loss.
Chronic periodontitis donors	periodontitis-associated bacteria presence	* Donors are medically healthy. * Slow to moderate attachment loss and bone destruction. * Good correlation between etiological factors and serverity of attachment loss.
Aggressive periodontitis donors	In vitro stimulation of blood with periodontitis-associated- and control bacteria	* Donors are medically healthy. * Rapid attachment loss and bone destruction. * Familial aggregation. * No correlation between etiological factors and serverity of attachment loss.
Aggressive periodontitis donors	Anti-CCP- and anti-P.g.-antibodies titers	* Donors are medically healthy. * Rapid attachment loss and bone destruction. * Familial aggregation. * No correlation between etiological factors and serverity of attachment loss.
Aggressive periodontitis donors	Analysis of selected single nucleotide polymorphisms (SNPs)	* Donors are medically healthy. * Rapid attachment loss and bone destruction. * Familial aggregation. * No correlation between etiological factors and serverity of attachment loss.
Chronic periodontitis donors	Anti-CCP- and anti-P.g.-antibodies titers	* Donors are medically healthy. * Slow to moderate attachment loss and bone destruction. * Good correlation between etiological factors and serverity of attachment loss.
Aggressive periodontitis donors	periodontitis-associated bacteria presence	* Donors are medically healthy. * Rapid attachment loss and bone destruction. * Familial aggregation. * No correlation between etiological factors and serverity of attachment loss.
Control donors	In vitro stimulation of blood with periodontitis-associated- and control bacteria	* Donors are medically healthy. * No sign of inflammatory conditions.
Control donors	Anti-CCP- and anti-P.g.-antibodies titers	* Donors are medically healthy. * No sign of inflammatory conditions.
Control donors	Analysis of selected single nucleotide polymorphisms (SNPs)	* Donors are medically healthy. * No sign of inflammatory conditions.
Control donors	periodontitis-associated bacteria presence	* Donors are medically healthy. * No sign of inflammatory conditions.

Primary Outcome Measures

Name	Time	Method
Anti-cyclic citrullinated peptides (anti-CCP) antibodies titers.	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.
P. gingivalis presence and related antibodies.	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.
periodontitis-associated- and control bacterial stimulation of host immune cells.	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.
Single nucleotide polymorphism (SNP) analysis.	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 Outcome Measures

Name	Time	Method
Presence of other periodontal bacteria.	Aug. 2020	Determination of the presence of other periodontal bacteria through RT-qPCR assays.
Cytokine profile in saliva.	Aug. 2020	Determination of the cytokine profile in saliva samples from subject with periodontitis and healthy controls with Luminex based technology.

Trial Locations

Locations (2)

Institute for Inflammation Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen University Hospital.; 🇩🇰 Copenhagen, Denmark

Section for Periodontology, Microbiology and Community Dentistry, Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen; 🇩🇰 Copenhagen, Denmark