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

Periodontitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873949
• Other study ID #: 2016-A00097-44
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2019
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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
• Saliva samples (1ml)

Other:
• Etiologic treatment
education on oral hygiene, scaling and root planing
• Psychometric tests
Spielberger State-Trait Anxiety Inventory and Cohen Perceived Stress Scale

Locations

Country	Name	City	State
France	Service Odontologie - Site Heydenreich - CHRU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		day 0
Secondary	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	day 0
Secondary	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	day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients)
Secondary	Identification of periodontal bacterial flora	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)
Secondary	Psychological stress score with Cohen Perceived Stress Scale		day 0
Secondary	Psychological stress score with Spielberger State-Trait Anxiety Inventory		day 0
Secondary	Quantification of salivary cortisol by ELISA to measure psychological stress		day 0