Clinical trial NCT03225950: Interaction Between Immune Cells and Bacteria Associated With Periodontitis
Official title: Interaction Between Immune Cells and Bacteria Associated With Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Periodontitis
Aggressive Periodontitis
Immunologic Disease
Microbial Disease
Periodontal Pocket
Inflammation
Inflammation Gum
Dysbiosis
Rheumatoid Arthritis
Generalized Aggressive Periodontitis
Generalized Chronic Periodontitis
Chronic Periodontitis
Keywords: Periodontal disease
Periodontitis
Aggressive periodontitis
Dysbiosis
Inflammation
Regulation
Cytokines
Bacteria
Porphyromonas gingivalis
Saliva
Anti-CCP
Peptidyl arginine deiminases
Single nucleotide polymorphisms
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Denmark
First posted: 2017-07-21
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes 170 participants, which are legally competent e.i. above 18 years of age and general decision competent. The participants are divided into three groups: 1) Participants with chronic periodontitis (n=35), 2) participants with aggressive periodontitis (n=35) and 3) healthy participants without periodontal disease (n=100). The participants are recruited from the Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark and assigned to a group in accordance with the periodontal disease classification system in 1999 American Academy of Periodontology.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: periodontitis-associated- and control bacterial stimulation of host immune cells.
timeFrame: Aug. 2020
measure: Anti-cyclic citrullinated peptides (anti-CCP) antibodies titers.
timeFrame: Aug. 2020
measure: P. gingivalis presence and related antibodies.
timeFrame: Aug. 2020
measure: Single nucleotide polymorphism (SNP) analysis.
timeFrame: Aug. 2020
Secondary outcomes:
measure: Cytokine profile in saliva.
timeFrame: Aug. 2020
measure: Presence of other periodontal bacteria.
timeFrame: Aug. 2020
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute for Inflammation Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen University Hospital.
city: Copenhagen
country: Denmark
facility: Section for Periodontology, Microbiology and Community Dentistry, Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Palle Holmstrup, DDS, PhD, Dr Odont
role: STUDY_DIRECTOR
affiliation: Institute for Inflammation Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
name: Claus Henrik Nielsen, PhD, MSc, MD
role: STUDY_DIRECTOR
References:
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citation: Belstrom D, Paster BJ, Fiehn NE, Bardow A, Holmstrup P. Salivary bacterial fingerprints of established oral disease revealed by the Human Oral Microbe Identification using Next Generation Sequencing (HOMINGS) technique. J Oral Microbiol. 2016 Jan 14;8:30170. doi: 10.3402/jom.v8.30170. eCollection 2016.
citation: Belstrom D, Holmstrup P, Bardow A, Kokaras A, Fiehn NE, Paster BJ. Comparative analysis of bacterial profiles in unstimulated and stimulated saliva samples. J Oral Microbiol. 2016 Mar 16;8:30112. doi: 10.3402/jom.v8.30112. eCollection 2016.