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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.
 
ClinicalTrials.gov Identifier: NCT01950962
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Tracking Information
First Submitted Date  ICMJE August 27, 2013
First Posted Date  ICMJE September 26, 2013
Last Update Posted Date July 30, 2019
Actual Study Start Date  ICMJE October 14, 2010
Actual Primary Completion Date June 12, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
Score of severity of oral inflammation [ Time Frame: up to 5 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role Of Phospholipid Transfer Proteins (Pltp) On Endotoxemia Caused By Buccal Inflammation
Official Title  ICMJE ROLE OF PHOSPHOLIPID TRANSFER PROTEINS (PLTP) ON ENDOTOXEMIA CAUSED BY BUCCAL INFLAMMATION
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Patients With Periodontal Disease
Intervention  ICMJE Other: Sampling of blood
Study Arms  ICMJE
  • slight periodontal disease
    Intervention: Other: Sampling of blood
  • moderate periodontal disease
    Intervention: Other: Sampling of blood
  • severe periodontal disease
    Intervention: Other: Sampling of blood
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2019)
242
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2013)
240
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 12, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

DEFINITIVE INCLUSION CRITERIA

- 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01950962
Other Study ID Numbers  ICMJE Lafon PHRC IR 2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor  ICMJE Centre Hospitalier Universitaire Dijon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP