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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 (TREM)

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ClinicalTrials.gov Identifier: NCT02873949
Recruitment Status : Unknown
Verified August 2016 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : August 22, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Periodontitis Biological: Crevicular samples (1-10µl) Biological: Saliva samples (1ml) Other: Etiologic treatment Other: Psychometric tests Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : April 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
1. Periodontitis patients
30 patients consulting at Odontology department for periodontal treatment
Biological: Crevicular samples (1-10µl)

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


Biological: Saliva samples (1ml)
Other: Etiologic treatment
education on oral hygiene, scaling and root planing

Other: Psychometric tests
Spielberger State-Trait Anxiety Inventory and Cohen Perceived Stress Scale

2. Control
10 patients not affected by periodontitis consulting at Odontology department for checkup of teeth state and/or scaling
Biological: Crevicular samples (1-10µl)

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


Biological: Saliva samples (1ml)
Other: Psychometric tests
Spielberger State-Trait Anxiety Inventory and Cohen Perceived Stress Scale




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873949


Contacts
Contact: Catherine BISSON catherine.bisson@univ-lorraine.fr

Locations
France
Service Odontologie - Site Heydenreich - CHRU Nancy Recruiting
Nancy, France
Contact: Catherine BISSON         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Catherine BISSON Service Odontologie - Site Heydenreich - CHRU Nancy
Study Chair: Sébastien GIBOT Service Réanimation Médicale - Hôpital Central - CHRU Nancy

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02873949     History of Changes
Other Study ID Numbers: 2016-A00097-44
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Central Hospital, Nancy, France:
immunology factors
TREM
stress

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases