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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01950962
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : July 30, 2019
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment Phase
Patients With Periodontal Disease Other: Sampling of blood Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Actual Study Start Date : October 14, 2010
Actual Primary Completion Date : June 12, 2014

Arm Intervention/treatment
slight periodontal disease Other: Sampling of blood
moderate periodontal disease Other: Sampling of blood
severe periodontal disease Other: Sampling of blood

Primary Outcome Measures :
  1. Score of severity of oral inflammation [ Time Frame: up to 5 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Pre-Inclusion criteria:

  • 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

Exclusion Criteria:

  • 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 taken at least once during the 8 days preceding the definitive inclusion an anti-inflammatory dose of NSAIDS and/or a salicylate (blood sample)
  • 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
  • Patients with oral inflammation requiring treatment with antibiotics or anti-inflammatory drugs during the pre-inclusion
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01950962

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CHU Dijon
Dijon, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon Identifier: NCT01950962    
Other Study ID Numbers: Lafon PHRC IR 2010
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Periodontal Diseases
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Systemic Inflammatory Response Syndrome