PeriodontitisTREMNCT02873949
Analysis of Soluble TREM (Triggering Receptor Expressed on Myeloid Cells)-1 and -2 in Crevicular Fluid and Associated Bacterial Flora in Patients Affected by Periodontitis
A study testing Crevicular samples (1-10µl), Saliva samples (1ml) and Etiologic treatment in people with Periodontitis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Etiopathology of periodontitis is complex and various risk factors are known : Bacterial factors: major risk factor. Although the presence of periodontopathogen bacteria is necessary for the onset of periodontitis, these microorganisms are not sufficient for progression of all periodontal disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Crevicular samples (1-10µl), Saliva samples (1ml) and Etiologic treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All:
- Affiliation to social security plan
- Absence of refusal of patient
- Group 1. Periodontal patients:
- Affected by moderate to severe chronic periodontitis
- At least 2 distinct infected sites with periodontal pocket depth ≥ 5mm
Show all 10Show fewer
- Having not received any root planing during last 6 months before visit
- Group 2. Control:
- No periodontitis
- Consulting for dental checkup and eventually scaling
Who cannot join
- All:
- Pregnant women (change in bacterial flora) and breast-feeding
- Administration of systemic antibiotherapy or any treatment influencing periodontal environment (anti-inflammatory, anti-epileptic, immune-suppressor, calcium inhibitor) during 6 months before sample collection
- Patients having a pathology needing a prophylactic antibiotherapy (possibly influencing the treatment)
- Teeth with periapical inflammatory lesions of endodontic origin
- Person under guardianship
Show all 10Show fewer
- Group 1. Periodontal patients:
- Root planing during last 6 months before visit
- Group 2. Control:
- Periodontitis
Trial locations and contacts
1 site in 1 country.
About this study
Etiopathology of periodontitis is complex and various risk factors are known :
- Bacterial factors: major risk factor. Although the presence of periodontopathogen bacteria is necessary for the onset of periodontitis, these microorganisms are not sufficient for progression of all periodontal disease.
- Immune factor: host immune response modulates the disease evolution to destruction or recovery. The most studied cytokine in periodontology is IL-1 that induces various immune reactions and bone resorption directly or indirectly through the stimulation of prostaglandin E2 (PGE2) release. PGE2 activates the matrix metalloproteinases that are responsible of the degradation of bone extracellular matrix.
Read more
Cytokine production, especially TNFα, IL-1β, IL-6 and IL-8, by some immune cells is modulated by new identified molecules such as Triggering Receptor Expressed on Myeloid cells (TREM) whose role in periodontitis is unknown.
The purpose of this study is to compare concentrations of soluble TREM-1 and TREM-2 markers in infected sites and in healthy sites in patients affected by periodontitis.
Other purposes are
- Comparison of soluble TREM-1 and TREM-2 concentrations in healthy sites in patients affected by periodontitis and in healthy patients
- Comparison of soluble TREM-1 and TREM-2 concentrations before and after etiologic periodontitis treatment
- Estimation of the correlation between soluble TREM-1 and TREM-2 concentrations and clinical signs of periodontitis
- Description of soluble TREM-1/TREM-2 ratio before and after etiologic treatment
- Description of presence of some bacteria in sites analyzed for soluble TREM-1 and TREM-2
- Search for the most observed bacteria in presence of high concentrations of soluble TREM-1 and TREM-2 before and after etiologic treatment
- Evaluation of the impact of psychological stress measured through salivary cortisol level in saliva on TREM-1 and -2 expression
- Evaluation of the impact of psychological stress through stress and anxiety auto-questionnaires (Spielberger and Cohen) on soluble TREM-1 and TREM-2 concentrations in crevicular fluid of healthy and pathologic teeth.
- Conditions
- Periodontitis
- Being tested
- Crevicular samples (1-10µl), Saliva samples (1ml), Etiologic treatment, Psychometric tests
- Keywords
- immunology factors, TREM, stress
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crevicular samples (1-10µl)Biological
In periodontitis patients: from 2 sites affected by periodontitis and 1 healthy site, 2 samples/site, before and after treatment
In non-periodontitis individuals: 2 samples from 1 site
Saliva samples (1ml)Biological
Etiologic treatmentOther
education on oral hygiene, scaling and root planing
Psychometric testsOther
Spielberger State-Trait Anxiety Inventory and Cohen Perceived Stress Scale
| Study group | Role | What they receive |
|---|---|---|
| 1. Periodontitis patients | Other | 30 patients consulting at Odontology department for periodontal treatment Receives: Biological: Crevicular samples (1-10µl); Biological: Saliva samples (1ml); Other: Etiologic treatment; Other: Psychometric tests |
| 2. Control | Other | 10 patients not affected by periodontitis consulting at Odontology department for checkup of teeth state and/or scaling Receives: Biological: Crevicular samples (1-10µl); Biological: Saliva samples (1ml); Other: Psychometric tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid from 2 distant sites affected by periodontitis and 1 healthy site of each periodontitis patients at first consultation
Measured: day 0
Secondary outcomes (6)
Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid from healthy sites of periodontitis patients and non-periodontitis patients at first consultation
Crevicular fluid from 3 sites (2 distant affected by periodontitis and 1 healthy) of periodontitis patients and from 1 healthy site of non-periodontitis patients
Measured: day 0
Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid of periodontitis patients before and after etiologic treatment of periodontitis
Crevicular fluid from 3 sites (2 distant affected by periodontitis and 1 healthy) of periodontitis patients
Measured: day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients)
Identification of periodontal bacterial flora
The kit microIDent®plus11 (Hain, Lifesciences) allows the identification by PCR of the most pathogen periodontal bacteria.
Measured: day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients)
Psychological stress score with Cohen Perceived Stress Scale
Measured: day 0
Psychological stress score with Spielberger State-Trait Anxiety Inventory
Measured: day 0
Quantification of salivary cortisol by ELISA to measure psychological stress
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine BISSON, Principal investigator, Service Odontologie - Site Heydenreich - CHRU NancySébastien GIBOT, Study chair, Service Réanimation Médicale - Hôpital Central - CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873949
- Sponsor's protocol ID
- 2016-A00097-44
- Acronym
- TREM
- Status last verified
- Jan 2019
- First submitted
- 17 Aug 2016
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Soluble TREM (Triggering Receptor Expressed on Myeloid Cells)-1 and -2 in Crevicular Fluid and Associated Bacterial Flora in Patients Affected by Periodontitis
- ClinicalTrials.gov ID
- NCT02873949
- Acronym / sponsor ID
- TREM / 2016-A00097-44
- Conditions
- Periodontitis
- Keywords
- immunology factors, TREM, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 22 Aug 2016 (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.
Etiopathology of periodontitis is complex and various risk factors are known :
- Bacterial factors: major risk factor. Although the presence of periodontopathogen bacteria is necessary for the onset of periodontitis, these microorganisms are not sufficient for progression of all periodontal disease.
- Immune factor: host immune response modulates the disease evolution to destruction or recovery. The most studied cytokine in periodontology is IL-1 that induces various immune reactions and bone resorption directly or indirectly through the stimulation of prostaglandin E2 (PGE2) release. PGE2 activates the matrix metalloproteinases that are responsible of the degradation of bone extracellular matrix.
Cytokine production, especially TNFα, IL-1β, IL-6 and IL-8, by some immune cells is modulated by new identified molecules such as Triggering Receptor Expressed on Myeloid cells (TREM) whose role in periodontitis is unknown.
The purpose of this study is to compare concentrations of soluble TREM-1 and TREM-2 markers in infected sites and in healthy sites in patients affected by periodontitis.
Other purposes are
- Comparison of soluble TREM-1 and TREM-2 concentrations in healthy sites in patients affected by periodontitis and in healthy patients
- Comparison of soluble TREM-1 and TREM-2 concentrations before and after etiologic periodontitis treatment
- Estimation of the correlation between soluble TREM-1 and TREM-2 concentrations and clinical signs of periodontitis
- Description of soluble TREM-1/TREM-2 ratio before and after etiologic treatment
- Description of presence of some bacteria in sites analyzed for soluble TREM-1 and TREM-2
- Search for the most observed bacteria in presence of high concentrations of soluble TREM-1 and TREM-2 before and after etiologic treatment
- Evaluation of the impact of psychological stress measured through salivary cortisol level in saliva on TREM-1 and -2 expression
- Evaluation of the impact of psychological stress through stress and anxiety auto-questionnaires (Spielberger and Cohen) on soluble TREM-1 and TREM-2 concentrations in crevicular fluid of healthy and pathologic teeth.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Periodontitis patients | Other | Biological: Crevicular samples (1-10µl), Biological: Saliva samples (1ml), Other: Etiologic treatment, Other: Psychometric tests30 patients consulting at Odontology department for periodontal treatment |
| 2. Control | Other | Biological: Crevicular samples (1-10µl), Biological: Saliva samples (1ml), Other: Psychometric tests10 patients not affected by periodontitis consulting at Odontology department for checkup of teeth state and/or scaling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Affiliation to social security plan
- Absence of refusal of patient
- Affected by moderate to severe chronic periodontitis
- At least 2 distinct infected sites with periodontal pocket depth ≥ 5mm
- Having not received any root planing during last 6 months before visit
Key exclusion criteria (10 listed)
- Pregnant women (change in bacterial flora) and breast-feeding
- Administration of systemic antibiotherapy or any treatment influencing periodontal environment (anti-inflammatory, anti-epileptic, immune-suppressor, calcium inhibitor) during 6 months before sample collection
- Patients having a pathology needing a prophylactic antibiotherapy (possibly influencing the treatment)
- Teeth with periapical inflammatory lesions of endodontic origin
- Person under guardianship
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 |
|---|---|---|
| Crevicular samples (1-10µl)In periodontitis patients: from 2 sites affected by periodontitis and 1 healthy site, 2 samples/site, before and after treatment In non-periodontitis individuals: 2 samples from 1 site | Biological | 1. Periodontitis patients, 2. Control |
| Saliva samples (1ml) | Biological | 1. Periodontitis patients, 2. Control |
| Etiologic treatmenteducation on oral hygiene, scaling and root planing | Other | 1. Periodontitis patients |
| Psychometric testsSpielberger State-Trait Anxiety Inventory and Cohen Perceived Stress Scale | Other | 1. Periodontitis patients, 2. Control |
Primary outcome
Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid from 2 distant sites affected by periodontitis and 1 healthy site of each periodontitis patients at first consultation
Time frame: day 0
6 secondary outcomes
Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid from healthy sites of periodontitis patients and non-periodontitis patients at first consultation
Time frame: day 0
Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid of periodontitis patients before and after etiologic treatment of periodontitis
Time frame: day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients)
Identification of periodontal bacterial flora
Time frame: day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients)
Psychological stress score with Cohen Perceived Stress Scale
Time frame: day 0
Psychological stress score with Spielberger State-Trait Anxiety Inventory
Time frame: day 0
Quantification of salivary cortisol by ELISA to measure psychological stress
Time frame: day 0
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 1 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Catherine BISSON principal investigator
Service Odontologie - Site Heydenreich - CHRU Nancy
Sébastien GIBOT study chair
Service Réanimation Médicale - Hôpital Central - CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crevicular samples (1-10µl), Saliva samples (1ml) and Etiologic treatment in people with Periodontitis, run by Central Hospital, Nancy, France 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 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: finished, as of the sponsor's last update on 1 Feb 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?
Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid from 2 distant sites affected by periodontitis and 1 healthy site of each periodontitis patients at first consultation (time frame: day 0). 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 1 Feb 2019.