Role Of Phospholipid Transfer Proteins (Pltp) On Endotoxemia Caused By Buccal Inflammation

NCT01950962 | Completed

• 1 other identifier: Lafon PHRC IR 2010
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

This is a transversal double-centre study. Patients will be recruited from outpatient consultations. They will have buccal inflammation caused by periodontal disease (frequent oral infections, mostly with GRAM (-) bacteria). Three groups of 80 patients, corresponding to slight, moderate and severe periodontal disease, will be formed according to the results of radiological and clinical examinations.

Conditions

Patients With Periodontal Disease

Outcome Measures

Primary Outcomes (1)

• Score of severity of oral inflammation

  up to 5 days

Study Arms (3)

slight periodontal disease

OTHER

Other: Sampling of blood

moderate periodontal disease

OTHER

Other: Sampling of blood

severe periodontal disease

OTHER

Other: Sampling of blood

Interventions

Sampling of blood OTHER

moderate periodontal disease; severe periodontal disease; slight periodontal disease

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons aged from 35 to 80 years old
• Persons who have provided written informed consent
• Patients with periodontal disease whatever the severity with at least one molar or one premolar on the dental arch
• Possibility to examine the oral cavity (patient able to open mouth)
• Possibility to do an orthopantomogram (sitting position required and patient able to clench jaws)
• Patient able to understand French
• Patient who accepts to provide fasting blood sample within the five days following the initial consultation
• \- Patient present for the fasting blood sample within five days following the initial consultation Patients will be matched for sex and, as much as possible, for age in the three groups and for the severity of the periodontal disease

You may not qualify if:

• Persons not covered by the national health insurance agency
• Patients with a high risk of infectious endocarditis who require prophylaxis for any medical act involving blood
• Patients who have had long-term treatment (\>6 months) with corticoids at a dose of at least 15 mg per day
• Patients on antibiotics less than 15 days before the blood sample
• Scaling during the 24 hours before the blood sample
• History of oral cancer or cancer of the pharynx
• Active cancer (patient undergoing treatment or diagnosis within the previous 5 years)
• Iatrogenic, spontaneous or therapeutic immunodepression (patient on immunosuppressants or antiretrovirals),
• Systemic or organ specific inflammatory syndrome not related to the periodontal disease
• proven bacterial, viral or fungal Infection either developing or being treated (urinary, prostate infection)
• Inflammatory cancer (solid tumour, malignant hemopathy)
• Pregnancy
• Impossibility to cooperate due to a psychiatric disease, dementia
• Patients unable to understand the protocol

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon

Dijon, 21000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: September 26, 2013
• Study Start: October 14, 2010
• Primary Completion: June 12, 2014
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

FR (1)