Aggressive PeriodontitisPAGNCT01993368
Analysis of Osteoimmune Interactions Linking Inflammation and Bone Destruction in Aggressive Periodontitis
A study testing flow cytometry in people with Aggressive Periodontitis and Chronic Periodontitis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Periodontitis are inflammatory diseases characterized by the destruction of the tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the severity and rapidity of bone loss, much more important… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggressive Periodontitis, Chronic Periodontitis
- What is being tested?
- flow cytometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Young patients not suffering of any médical conditions
- Small amount of calculus detected
- Pocket depth >5mm
- Alveolar Bone loss >50%
- Evident presence of calculus above or under the gingiva
- Pocket depth >5mm
- Young patients in need of impacted wisdom teeth removal
- And not suffering of chronic or agressive periodontitis
Who cannot join
- Patients with blood disorder
- Patients presenting with liver, kidney, or vascular disorder, and /or psychiatric disorder
- Patients who have allergies
- Patients taking biphosphonates, anticoagulant drugs, or anticonvulsivant
- Patients who have had a cancer of the mouth, and/or treated by radiotherapy
- Patients who have taken anti-inflammatory drugs, and/or anti-cancer drugs, and/or immuno-suppresive drugs in the past 6 months
Show all 10Show fewer
- Patients who have had a periodontal treatment in the past 12 months
- Pregnant Women
- Patients juged difficult to follow by the investigator
- Vulnerable patients
Trial locations and contacts
1 site in 1 country.
About this study
Periodontitis are inflammatory diseases characterized by the destruction of the tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the severity and rapidity of bone loss, much more important for AP than CP. In both forms, the link with uncontrolled activation of the immune system is largely admitted. Despite the physiopathology of CP is fairly well studied, very few data are available regarding AP. The investigators aim is to understand the severity of AP by analyzing the proportion and action of immune and mesnchymal cells potentially involved in bone destruction, on biopsies of periodontal granulation tissue (surgical waste) and blood. Three groups of 20 patients will be included: affected with AP, CP or controls (necessitating an extraction of wisdom teeth).
Read the detailed description
Context: Periodontitis are inflammatory diseases affecting the periodontium and characterized by the destruction of the tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the severity and rapidity of bone loss, much more important for AP than CP. In both forms, the link with uncontrolled activation of the immune system is largely admitted. But despite the physiopathology of CP is fairly well studied, very few data are available regarding AP. Based on the investigators previous studies, their hypothesis to explain this severity is the existence of a vicious circle involving immune cells, mesenchymal cells and OCLs, that would maintain and amplify inflammation and bone loss.
Study: this is a transversal, interventional and single-center study. It includes 3 groups of 20 patients: affected with AP, CP or controls (necessitating an extraction of wisdom teeth).
Aims: the investigators will compare the proportion of immune and mesenchymal cells in the 3 groups of patients to identify the populations potentially involved in bone destruction. The investigators will compare in vitro their capacity to induce OCL differentiation in order to determine their role in bone loss. The investigators will also compare the capacity of OCLs and mesenchymal cells to activate T cells, in order to determine their role in inflammation.
Methodology: patients will be recruited in the department of periodontology, CHU of Nice. After signing the informed consent, a biopsy of periodontal granulation tissue (surgical waste) will be collected during the usual treatment of these diseases, as well as a blood sample. Then, patients will leave the study. Cells from the biopsies will be analyzed by flow cytometry to determine the proportion of lymphocytic, monocytic and mesenchymal cells. In vitro, their capacity to induce OCL differentiation or to activate T cells will be determined. From the blood samples, OCLs will be generated to study their capacity to activate T cells.
Chronology of consultations and examinations: 3 visits are planned: (1) a routine visit corresponding to the usual treatment of the patient during which it is proposed to participate in the study, (2) a visit to obtaining consent, clinical examination, criteria verification and (3) a visit corresponding to the usual treatment in which will be collected tissue biopsies and blood.
- Conditions
- Aggressive Periodontitis, Chronic Periodontitis
- Being tested
- flow cytometry
- Keywords
- wisdom teeth extraction
- Medical subject headings
- Aggressive Periodontitis, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flow cytometryOther
Also called proportion of lymphocytes, myeloid and mesenchymal populations in the samples, as determined by flow cytometry.
These populations will be identified by different combinations of antibodies to identify:
- T cell subsets (CD45, CD3, CD4, CD8, CD45RA, CD69, CD28, TCRαβ, TCRγδ, CD197, CD25, FoxP3), B cells (CD45, CD19, HLA-DR, IgA), cells NK (CD45, CD3, CD56).
- Monocyte subsets (CD45, CD11b, CD14, CD16, CD1c, HLA-DR)
- Mesenchymal stromal cells (CD45, HLA-ABC, CD105, CD90, CD73)
| Study group | Role | What they receive |
|---|---|---|
| chronic periodontitis | Other | biopsy of periodontal granulation tissue (surgical waste) Receives: Other: flow cytometry |
| aggressive periodontitis (AP) | Other | biopsy of periodontal granulation tissue (surgical waste) Receives: Other: flow cytometry |
| controls | Other | necessitating an extraction of wisdom teeth Receives: Other: flow cytometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of lymphocytes, myeloid and mesenchymal populations in the samples
determined by flow cytometry
Measured: At the surgery time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Not enough patient enrolled in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive PeriodontitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme SURMENIAN, MD, Principal investigator, Odontology Department, NIce University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993368
- Sponsor's protocol ID
- 13-PP-07
- Acronym
- PAG
- Status last verified
- Feb 2018
- First submitted
- 15 Nov 2013
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Osteoimmune Interactions Linking Inflammation and Bone Destruction in Aggressive Periodontitis
- ClinicalTrials.gov ID
- NCT01993368
- Acronym / sponsor ID
- PAG / 13-PP-07
- Conditions
- Aggressive Periodontitis, Chronic Periodontitis
- Keywords
- wisdom teeth extraction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patient enrolled in the study
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Nov 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.
Periodontitis are inflammatory diseases characterized by the destruction of the tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the severity and rapidity of bone loss, much more important for AP than CP. In both forms, the link with uncontrolled activation of the immune system is largely admitted. Despite the physiopathology of CP is fairly well studied, very few data are available regarding AP. The investigators aim is to understand the severity of AP by analyzing the proportion and action of immune and mesnchymal cells potentially involved in bone destruction, on biopsies of periodontal granulation tissue (surgical waste) and blood. Three groups of 20 patients will be included: affected with AP, CP or controls (necessitating an extraction of wisdom teeth).
Detailed description
Context: Periodontitis are inflammatory diseases affecting the periodontium and characterized by the destruction of the tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the severity and rapidity of bone loss, much more important for AP than CP. In both forms, the link with uncontrolled activation of the immune system is largely admitted. But despite the physiopathology of CP is fairly well studied, very few data are available regarding AP. Based on the investigators previous studies, their hypothesis to explain this severity is the existence of a vicious circle involving immune cells, mesenchymal cells and OCLs, that would maintain and amplify inflammation and bone loss.
Study: this is a transversal, interventional and single-center study. It includes 3 groups of 20 patients: affected with AP, CP or controls (necessitating an extraction of wisdom teeth).
Aims: the investigators will compare the proportion of immune and mesenchymal cells in the 3 groups of patients to identify the populations potentially involved in bone destruction. The investigators will compare in vitro their capacity to induce OCL differentiation in order to determine their role in bone loss. The investigators will also compare the capacity of OCLs and mesenchymal cells to activate T cells, in order to determine their role in inflammation.
Methodology: patients will be recruited in the department of periodontology, CHU of Nice. After signing the informed consent, a biopsy of periodontal granulation tissue (surgical waste) will be collected during the usual treatment of these diseases, as well as a blood sample. Then, patients will leave the study. Cells from the biopsies will be analyzed by flow cytometry to determine the proportion of lymphocytic, monocytic and mesenchymal cells. In vitro, their capacity to induce OCL differentiation or to activate T cells will be determined. From the blood samples, OCLs will be generated to study their capacity to activate T cells.
Chronology of consultations and examinations: 3 visits are planned: (1) a routine visit corresponding to the usual treatment of the patient during which it is proposed to participate in the study, (2) a visit to obtaining consent, clinical examination, criteria verification and (3) a visit corresponding to the usual treatment in which will be collected tissue biopsies and blood.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chronic periodontitis | Other | Other: flow cytometrybiopsy of periodontal granulation tissue (surgical waste) |
| aggressive periodontitis (AP) | Other | Other: flow cytometrybiopsy of periodontal granulation tissue (surgical waste) |
| controls | Other | Other: flow cytometrynecessitating an extraction of wisdom teeth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (10 listed)
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 |
|---|---|---|
| flow cytometryAlso: proportion of lymphocytes, myeloid and mesenchymal populations in the samples, as determined by flow cytometry.These populations will be identified by different combinations of antibodies to identify: * T cell subsets (CD45, CD3, CD4, CD8, CD45RA, CD69, CD28, TCRαβ, TCRγδ, CD197, CD25, FoxP3), B cells (CD45, CD19, HLA-DR, IgA), cells NK (CD45, CD3, CD56). * Monocyte subsets (CD45, CD11b, CD14, CD16, CD1c, HLA-DR) * Mesenchymal stromal cells (CD45, HLA-ABC, CD105, CD90, CD73) | Other | aggressive periodontitis (AP), chronic periodontitis, controls |
Primary outcome
proportion of lymphocytes, myeloid and mesenchymal populations in the samples
Time frame: At the surgery time
determined by flow cytometry
Results and safety
The study was stopped early (reason given: Not enough patient enrolled in the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
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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.
Jérôme SURMENIAN, MD principal investigator
Odontology Department, NIce University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flow cytometry in people with Aggressive Periodontitis and Chronic Periodontitis, run by Centre Hospitalier Universitaire de Nice 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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Feb 2018. 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 was stopped early (reason given: Not enough patient enrolled in the study). Results are not available in the source record.
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?
proportion of lymphocytes, myeloid and mesenchymal populations in the samples (time frame: At the surgery time). 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 7 Feb 2018.