NCT02873949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

August 17, 2016

Last Update Submit

January 30, 2019

Conditions

Periodontitis

Keywords

immunology factorsTREMstress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • 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)

  • Identification of periodontal bacterial flora

    day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients)

  • Psychological stress score with Cohen Perceived Stress Scale

    day 0

  • Psychological stress score with Spielberger State-Trait Anxiety Inventory

    day 0

  • +1 more secondary outcomes

Study Arms (2)

1. Periodontitis patients

OTHER

30 patients consulting at Odontology department for periodontal treatment

Biological: Crevicular samples (1-10µl)Biological: Saliva samples (1ml)Other: Etiologic treatmentOther: Psychometric tests

2. Control

OTHER

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

Biological: Crevicular samples (1-10µl)Biological: Saliva samples (1ml)Other: Psychometric tests

Interventions

Crevicular samples (1-10µl)BIOLOGICAL

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

1. Periodontitis patients2. Control
Saliva samples (1ml)BIOLOGICAL
1. Periodontitis patients2. Control
Etiologic treatmentOTHER

education on oral hygiene, scaling and root planing

1. Periodontitis patients
Psychometric testsOTHER

Spielberger State-Trait Anxiety Inventory and Cohen Perceived Stress Scale

1. Periodontitis patients2. Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Odontologie - Site Heydenreich - CHRU Nancy

Nancy, France

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Psychometrics

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Catherine BISSON

    Service Odontologie - Site Heydenreich - CHRU Nancy

    PRINCIPAL INVESTIGATOR

  • Sébastien GIBOT

    Service Réanimation Médicale - Hôpital Central - CHRU Nancy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 1, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)