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

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Biological: Crevicular samples (1-10µl); Biological: Saliva samples (1ml); Other: Etiologic treatment; Other: Psychometric tests

• Registration Number: NCT02873949
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-22
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Periodontitis patients	Crevicular samples (1-10µl)	30 patients consulting at Odontology department for periodontal treatment
1. Periodontitis patients	Psychometric tests	30 patients consulting at Odontology department for periodontal treatment
1. Periodontitis patients	Etiologic treatment	30 patients consulting at Odontology department for periodontal treatment
2. Control	Crevicular samples (1-10µl)	10 patients not affected by periodontitis consulting at Odontology department for checkup of teeth state and/or scaling
2. Control	Psychometric tests	10 patients not affected by periodontitis consulting at Odontology department for checkup of teeth state and/or scaling
2. Control	Saliva samples (1ml)	10 patients not affected by periodontitis consulting at Odontology department for checkup of teeth state and/or scaling
1. Periodontitis patients	Saliva samples (1ml)	30 patients consulting at Odontology department for periodontal treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	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
Identification of periodontal bacterial flora	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.
Psychological stress score with Cohen Perceived Stress Scale	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	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
Quantification of salivary cortisol by ELISA to measure psychological stress	day 0
Psychological stress score with Spielberger State-Trait Anxiety Inventory	day 0

Trial Locations

Locations (1)

Service Odontologie - Site Heydenreich - CHRU Nancy; 🇫🇷 Nancy, France