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
About this trial
This is an interventional basic science trial for Periodontitis focused on measuring immunology factors, TREM, stress
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
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
NCT ID
NCT02873949
First Posted
August 17, 2016
Last Updated
January 30, 2019
Sponsor
Central Hospital, Nancy, France
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
Learn more about this trial
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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