Patients With Periodontal DiseaseTOXIBNCT01950962
Role Of Phospholipid Transfer Proteins (Pltp) On Endotoxemia Caused By Buccal Inflammation
A study testing Sampling of blood in people with Patients With Periodontal Disease, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Patients With Periodontal Disease
- What is being tested?
- Sampling of blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2010to 12 Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ROLE OF PHOSPHOLIPID TRANSFER PROTEINS (PLTP) ON ENDOTOXEMIA CAUSED BY BUCCAL INFLAMMATION
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
- Being tested
- Sampling of blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of bloodOther
| Study group | Role | What they receive |
|---|---|---|
| slight periodontal disease | Other | Not described Receives: Other: Sampling of blood |
| moderate periodontal disease | Other | Not described Receives: Other: Sampling of blood |
| severe periodontal disease | Other | Not described Receives: Other: Sampling of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of severity of oral inflammation
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study start14 Oct 2010
- Primary completion12 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950962
- Sponsor's protocol ID
- Lafon PHRC IR 2010
- Acronym
- TOXIB
- Status last verified
- Jul 2019
- First submitted
- 27 Aug 2013
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROLE OF PHOSPHOLIPID TRANSFER PROTEINS (PLTP) ON ENDOTOXEMIA CAUSED BY BUCCAL INFLAMMATION
- ClinicalTrials.gov ID
- NCT01950962
- Acronym / sponsor ID
- TOXIB / Lafon PHRC IR 2010
- Conditions
- Patients With Periodontal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 14 Oct 2010 (actual)
- Primary completion
- 12 Jun 2014 (actual)
- First posted
- 26 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| slight periodontal disease | Other | Other: Sampling of blood |
| moderate periodontal disease | Other | Other: Sampling of blood |
| severe periodontal disease | Other | Other: Sampling of blood |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling of blood | Other | moderate periodontal disease, severe periodontal disease, slight periodontal disease |
Primary outcome
Score of severity of oral inflammation
Time frame: up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling of blood in people with Patients With Periodontal Disease, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of severity of oral inflammation (time frame: up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.