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)

January 30, 2019 updated by: Central Hospital, Nancy, France

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France
        • Service Odontologie - Site Heydenreich - CHRU Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 0
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
day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients)
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.
day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients)
Psychological stress score with Cohen Perceived Stress Scale
Time Frame: day 0
day 0
Psychological stress score with Spielberger State-Trait Anxiety Inventory
Time Frame: day 0
day 0
Quantification of salivary cortisol by ELISA to measure psychological stress
Time Frame: day 0
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 22, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00097-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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