PeriodontitisPAROMIPNCT04251650
PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal
An observational study of Periodontitis, run by Nantes University Hospital at 1 site in France.
Trial summary
A new classification of periodontal diseases was created in 2018. the investigators want to know if this clinical classification is based, or not, on a biological reality. To do this, the investigators will collect data from the clinical examination (clinical assessment and radiological assessment) as well as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- subgingival plaque sample and CGF sample
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 31 Mar 2020
- Phase
- Observational
- 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
Study population: All patient coming in consultation for generalized periodontitis .
Who may be able to join
- Men and women speaking and understanding French
- Aged over 18
- with generalized periodontitis (more than 30% of affected sites)
- Requiring non-surgical periodontal therapy
- with a minimum of 12 teeth (3 per quadrant), fitted or not
- Having given his oral consent to participate in the study
- Having given his written consent to participate in a biocollection
Who cannot join
- Less than 12 teeth present (3 teeth per quadrant)
- Presence of acute oral lesions (periodontal abscesses, endodontic abscesses, infectious or mycotic lesions…)
- Presence of ulcerative-necrotic gingivitis or periodontitis
- Presence of endo-periodontal lesions
- Chronic or systemic pathology or treatment that can influence the periodontal microbiota : immunotherapy, corticosteroid therapy, biotherapy, unbalanced diabetes, acute inflammatory rheumatism, neurological impairment…
- Antibiotic during the 3 month preceding inclusion
Show all 12Show fewer
- Psychological or linguistic disability preventing good understanding of the study
- Minors
- Major patients under legal protection
- Patients deprived of their liberty
- Pregnant or lactating woman
- Patient not affiliated to a health insurance scheme
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nantes Universitary Hospital
Nantes, Loire Atlantique, 44093
Assem Soueidan, PU-PH, +33 2 40 41 29 23, assem.soueidan@chu-nantes.fr
Assem SOUEIDAN, PU-PH
About this study
Official title: Search for a Microbiotic Signature Associated With Periodontitis According to the Chicago Classification 2018
A new classification of periodontal diseases was created in 2018. the investigators want to know if this clinical classification is based, or not, on a biological reality. To do this, the investigators will collect data from the clinical examination (clinical assessment and radiological assessment) as well as non-invasive samples of subgingival plaque and crevicular gingival fluid (CGF). The subgingival plaque samples will be analyzed to define the microbiotic profiles of the patients and the CGF determined to define their inflammatory expression profiles. These results will then be linked to the diagnosis of severity of periodontitis.
Read the detailed description
In the new classification of periodontal disease, the investigators will seek to know whether there is a specific bacterial signature associated with the severity of damage on the one hand, and the other hand, the investigators will search for cytokinic biomarkers which can be correlated with the severity of the damage.
In this study, the investigators propose to include 25 patients with periodontitis stage I and II versus stage III and IV according to Chicago classification (2018)
- Conditions
- Periodontitis
- Being tested
- subgingival plaque sample, CGF sample
- Keywords
- subgingival microbiota, chronic periodontitis, dysbiosis, deep sequencing, gingival crevicular fluid
- Medical subject headings
- Periodontitis, Chronic Periodontitis, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subgingival plaque sampleOther
for subgingival plaque sample, on three affected sites (PD>3mm) and three healthy sites (PD≤3mm), after supra-gingival plaque removal, sterile endodontic paper points were inserted in selects pockets for 30s to collect the subgingival plaque. The material was transferred into eppendorf tube, one for affected samples and one for healthy samples.
CGF sampleOther
each site was sampled with a PerioPaper Strip® (Oraflow), and the volumes collected were measured with a Periotron® (Oraflow). Then samples of affected sites were stowed in an eppendorf tube with 120µL of PBS Tween. The same procedure was performed for the healthy sites
| Study group | Role | What they receive |
|---|---|---|
| low severity | patient with periodontitis stage I and II Receives: Other: subgingival plaque sample; Other: CGF sample | |
| high severity | patient with periodontitis stage III and IV Receives: Other: subgingival plaque sample; Other: CGF sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota analysis of subgingival plaque
sample analysis by microbiome sequencing with 16S technics of subgingival plaque of affected sites and healthy sites
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Cytokinic concentrations in CGF
cytokinic concentration analysis (IL1β, IL , TNFα, IL2, IL4, IL10, IL17α) in CGF of affected sites and healthy sites
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 May 2019
- Primary completion30 Oct 2019
- Study completion31 Mar 2020 (estimated)
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 Nantes University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251650
- Sponsor's protocol ID
- 30042019
- Acronym
- PAROMIP
- Status last verified
- Jan 2020
- First submitted
- 30 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search for a Microbiotic Signature Associated With Periodontitis According to the Chicago Classification 2018
- ClinicalTrials.gov ID
- NCT04251650
- Acronym / sponsor ID
- PAROMIP / 30042019
- Conditions
- Periodontitis
- Keywords
- subgingival microbiota, chronic periodontitis, dysbiosis, deep sequencing, gingival crevicular fluid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 5 Feb 2020 (actual)
- 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.
A new classification of periodontal diseases was created in 2018. the investigators want to know if this clinical classification is based, or not, on a biological reality. To do this, the investigators will collect data from the clinical examination (clinical assessment and radiological assessment) as well as non-invasive samples of subgingival plaque and crevicular gingival fluid (CGF). The subgingival plaque samples will be analyzed to define the microbiotic profiles of the patients and the CGF determined to define their inflammatory expression profiles. These results will then be linked to the diagnosis of severity of periodontitis.
Detailed description
In the new classification of periodontal disease, the investigators will seek to know whether there is a specific bacterial signature associated with the severity of damage on the one hand, and the other hand, the investigators will search for cytokinic biomarkers which can be correlated with the severity of the damage.
In this study, the investigators propose to include 25 patients with periodontitis stage I and II versus stage III and IV according to Chicago classification (2018)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low severity | – | Other: subgingival plaque sample, Other: CGF samplepatient with periodontitis stage I and II |
| high severity | – | Other: subgingival plaque sample, Other: CGF samplepatient with periodontitis stage III and IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient coming in consultation for generalized periodontitis .
Key inclusion criteria (7 listed)
- Men and women speaking and understanding French
- Aged over 18
- with generalized periodontitis (more than 30% of affected sites)
- Requiring non-surgical periodontal therapy
- with a minimum of 12 teeth (3 per quadrant), fitted or not
Key exclusion criteria (12 listed)
- Less than 12 teeth present (3 teeth per quadrant)
- Presence of acute oral lesions (periodontal abscesses, endodontic abscesses, infectious or mycotic lesions…)
- Presence of ulcerative-necrotic gingivitis or periodontitis
- Presence of endo-periodontal lesions
- Chronic or systemic pathology or treatment that can influence the periodontal microbiota : immunotherapy, corticosteroid therapy, biotherapy, unbalanced diabetes, acute inflammatory rheumatism, neurological impairment…
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 |
|---|---|---|
| subgingival plaque samplefor subgingival plaque sample, on three affected sites (PD>3mm) and three healthy sites (PD≤3mm), after supra-gingival plaque removal, sterile endodontic paper points were inserted in selects pockets for 30s to collect the subgingival plaque. The material was transferred into eppendorf tube, one for affected samples and one for healthy samples. | Other | high severity, low severity |
| CGF sampleeach site was sampled with a PerioPaper Strip® (Oraflow), and the volumes collected were measured with a Periotron® (Oraflow). Then samples of affected sites were stowed in an eppendorf tube with 120µL of PBS Tween. The same procedure was performed for the healthy sites | Other | high severity, low severity |
Primary outcome
Microbiota analysis of subgingival plaque
Time frame: through study completion, an average of 1 year
sample analysis by microbiome sequencing with 16S technics of subgingival plaque of affected sites and healthy sites
1 secondary outcome
Cytokinic concentrations in CGF
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by Nantes University Hospital 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assem SOUEIDAN, Pr (02.40.41.29.23 ext. +(33), assem.soueidan@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota analysis of subgingival plaque (time frame: through study completion, an average of 1 year). 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 5 Feb 2020.