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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)

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Crevicular samples (1-10µl)
Saliva samples (1ml)
Etiologic treatment
Psychometric tests
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Periodontitis focused on measuring immunology factors, TREM, stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Service Odontologie - Site Heydenreich - CHRU Nancy

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1. Periodontitis patients

2. Control

Arm Description

30 patients consulting at Odontology department for periodontal treatment

10 patients not affected by periodontitis consulting at Odontology department for checkup of teeth state and/or scaling

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Crevicular fluid from 3 sites (2 distant affected by periodontitis and 1 healthy) of periodontitis patients
Identification of periodontal bacterial flora
The kit microIDent®plus11 (Hain, Lifesciences) allows the identification by PCR of the most pathogen periodontal bacteria.
Psychological stress score with Cohen Perceived Stress Scale
Psychological stress score with Spielberger State-Trait Anxiety Inventory
Quantification of salivary cortisol by ELISA to measure psychological stress

Full Information

First Posted
August 17, 2016
Last Updated
January 30, 2019
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02873949
Brief 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
Acronym
TREM
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 Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Comparison of soluble TREM-1 and TREM-2 concentrations in healthy sites in patients affected by periodontitis and in healthy patients Comparison of soluble TREM-1 and TREM-2 concentrations before and after etiologic periodontitis treatment Estimation of the correlation between soluble TREM-1 and TREM-2 concentrations and clinical signs of periodontitis Description of soluble TREM-1/TREM-2 ratio before and after etiologic treatment Description of presence of some bacteria in sites analyzed for soluble TREM-1 and TREM-2 Search for the most observed bacteria in presence of high concentrations of soluble TREM-1 and TREM-2 before and after etiologic treatment Evaluation of the impact of psychological stress measured through salivary cortisol level in saliva on TREM-1 and -2 expression 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
immunology factors, TREM, stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Periodontitis patients
Arm Type
Other
Arm Description
30 patients consulting at Odontology department for periodontal treatment
Arm Title
2. Control
Arm Type
Other
Arm Description
10 patients not affected by periodontitis consulting at Odontology department for checkup of teeth state and/or scaling
Intervention Type
Biological
Intervention Name(s)
Crevicular samples (1-10µl)
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Saliva samples (1ml)
Intervention Type
Other
Intervention Name(s)
Etiologic treatment
Intervention Description
education on oral hygiene, scaling and root planing
Intervention Type
Other
Intervention Name(s)
Psychometric tests
Intervention Description
Spielberger State-Trait Anxiety Inventory and Cohen Perceived Stress Scale
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Description
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
Time Frame
day 0
Title
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
Description
Crevicular fluid from 3 sites (2 distant affected by periodontitis and 1 healthy) of periodontitis patients
Time Frame
day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients)
Title
Identification of periodontal bacterial flora
Description
The kit microIDent®plus11 (Hain, Lifesciences) allows the identification by PCR of the most pathogen periodontal bacteria.
Time Frame
day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients)
Title
Psychological stress score with Cohen Perceived Stress Scale
Time Frame
day 0
Title
Psychological stress score with Spielberger State-Trait Anxiety Inventory
Time Frame
day 0
Title
Quantification of salivary cortisol by ELISA to measure psychological stress
Time Frame
day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine BISSON
Organizational Affiliation
Service Odontologie - Site Heydenreich - CHRU Nancy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sébastien GIBOT
Organizational Affiliation
Service Réanimation Médicale - Hôpital Central - CHRU Nancy
Official's Role
Study Chair
Facility Information:
Facility Name
Service Odontologie - Site Heydenreich - CHRU Nancy
City
Nancy
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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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

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