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NCT Number: NCT02873949

Analysis of Soluble TREM (Triggering Receptor Expressed on Myeloid Cells)-1 and -2 in Crevicular Fluid and Associated Bacterial Flora in Patients Affected by Periodontitis

Etiopathology of periodontitis is complex and various risk factors are known :

* Bacterial factors: major risk factor. Although the presence of periodontopathogen bacteria is necessary for the onset of periodontitis, these microorganisms are not sufficient for progression of all periodontal disease. * Immune factor: host immune response modulates the disease evolution to destruction or recovery. The most studied cytokine in periodontology is IL-1 that induces various immune reactions and bone resorption directly or indirectly through the stimulation of prostaglandin E2 (PGE2) release. PGE2 activates the matrix metalloproteinases that are responsible of the degradation of bone extracellular matrix.

Cytokine production, especially TNFα, IL-1β, IL-6 and IL-8, by some immune cells is modulated by new identified molecules such as Triggering Receptor Expressed on Myeloid cells (TREM) whose role in periodontitis is unknown.

The purpose of this study is to compare concentrations of soluble TREM-1 and TREM-2 markers in infected sites and in healthy sites in patients affected by periodontitis.

Other purposes are

1. Comparison of soluble TREM-1 and TREM-2 concentrations in healthy sites in patients affected by periodontitis and in healthy patients 2. Comparison of soluble TREM-1 and TREM-2 concentrations before and after etiologic periodontitis treatment 3. Estimation of the correlation between soluble TREM-1 and TREM-2 concentrations and clinical signs of periodontitis 4. Description of soluble TREM-1/TREM-2 ratio before and after etiologic treatment 5. Description of presence of some bacteria in sites analyzed for soluble TREM-1 and TREM-2 6. Search for the most observed bacteria in presence of high concentrations of soluble TREM-1 and TREM-2 before and after etiologic treatment 7. Evaluation of the impact of psychological stress measured through salivary cortisol level in saliva on TREM-1 and -2 expression 8. Evaluation of the impact of psychological stress through stress and anxiety auto-questionnaires (Spielberger and Cohen) on soluble TREM-1 and TREM-2 concentrations in crevicular fluid of healthy and pathologic teeth.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service Odontologie - Site Heydenreich - CHRU Nancy

Nancy, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

All:

  • Affiliation to social security plan
  • Absence of refusal of patient

Group 1. Periodontal patients:

  • Affected by moderate to severe chronic periodontitis
  • At least 2 distinct infected sites with periodontal pocket depth ≥ 5mm
  • Having not received any root planing during last 6 months before visit

Group 2. Control:

  • No periodontitis
  • Consulting for dental checkup and eventually scaling

Exclusion criteria

All:

  • Pregnant women (change in bacterial flora) and breast-feeding
  • Administration of systemic antibiotherapy or any treatment influencing periodontal environment (anti-inflammatory, anti-epileptic, immune-suppressor, calcium inhibitor) during 6 months before sample collection
  • Patients having a pathology needing a prophylactic antibiotherapy (possibly influencing the treatment)
  • Teeth with periapical inflammatory lesions of endodontic origin
  • Person under guardianship

Group 1. Periodontal patients:

  • Root planing during last 6 months before visit

Group 2. Control:

  • Periodontitis

Treatment and study plan

Crevicular samples (1-10µl)

Biological

In periodontitis patients: from 2 sites affected by periodontitis and 1 healthy site, 2 samples/site, before and after treatment

In non-periodontitis individuals: 2 samples from 1 site

Saliva samples (1ml)

Biological

Etiologic treatment

Other

education on oral hygiene, scaling and root planing

Psychometric tests

Other

Spielberger State-Trait Anxiety Inventory and Cohen Perceived Stress Scale

Primary outcomes

  1. Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid from 2 distant sites affected by periodontitis and 1 healthy site of each periodontitis patients at first consultation

    Time frame: day 0

Secondary outcomes

  1. Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid from healthy sites of periodontitis patients and non-periodontitis patients at first consultation

    Time frame: day 0

    Crevicular fluid from 3 sites (2 distant affected by periodontitis and 1 healthy) of periodontitis patients and from 1 healthy site of non-periodontitis patients

  2. Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid of periodontitis patients before and after etiologic treatment of periodontitis

    Time frame: day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients)

    Crevicular fluid from 3 sites (2 distant affected by periodontitis and 1 healthy) of periodontitis patients

  3. Identification of periodontal bacterial flora

    Time frame: day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients)

    The kit microIDent®plus11 (Hain, Lifesciences) allows the identification by PCR of the most pathogen periodontal bacteria.

  4. Psychological stress score with Cohen Perceived Stress Scale

    Time frame: day 0

  5. Psychological stress score with Spielberger State-Trait Anxiety Inventory

    Time frame: day 0

  6. Quantification of salivary cortisol by ELISA to measure psychological stress

    Time frame: day 0

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: TREM

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 22, 2016
Registry last updated
Feb 1, 2019

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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