PeriodontitisCB-PARO2NCT06012019
Periodontitis and Inflammation: Study on Biological Samples
An observational study of Periodontitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Periodontitis is a major public health problem because it is widespread in the adult population. It leads to the irreversible destruction of the anchoring tissues of the teeth, and represents a modifiable risk factor for systemic inflammatory pathologies. 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?
- Biological sampling in Periodontitis Case and Biological sampling in Gingivitis Case
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2025to 15 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: This study concerns adult patients consulting the oral medicine department at Hôpital Charles Foix (AP-HP, Ivry sur Seine) Cases : * Group 1 = Patients should have bacterial gingivitis * Group 2 = Patients should have stage 3 or 4 localized or generalized bacterial periodontitis. The diagnosis of gingivitis or periodontitis is based on the elements noted during the clinical interview and examination, in accordance with the Chicago 2017 classification. Control: Patient with healthy gingiva on intact or reduced periodontium with no history of periodontitis, in accordance with the Chicago 2017 classification.
Who may be able to join
- Common criteria for all patient groups
- Patient > 18 years old
- Patient affiliated to a national health insurance
- Patient who speaks and understands French well enough to be able to read and understand the study information note.
- Patient who does not object to his participation in the study
- Specific Criteria :
Show all 9Show fewer
- Control Group = BOP < 10%, PI<20%, PD≤ 3mm
- Gingivitis cases = BOP ≥ 10%, PD≤ 3mm
- Periodontitis cases = BOP ≥ 10%, PD> 3mm
Who cannot join
- Patients who have received antibiotic prophylaxis, antibiotic therapy, or anti-inflammatory treatment within 3 months prior to inclusion
- Pregnant or breastfeeding women
- Patients suffering from a disease with defective neutrophil number, activity, activation or function
- Patient deprived of liberty by judicial or administrative decision.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Charles-Foix Hospital
Ivry-sur-Seine, 94200
Marjolaine Gosset, PU-PH, 01 49 59 48 11, marjolaine.gosset@u-paris.fr
Sandrine Dos Santos, 01 49 59 48 11, sandrine.dossantos2@aphp.fr
About this study
Official title: Characterization of the Immuno-inflammatory Response Involved in Bone Destruction During Periodontitis: Study on Biological Samples With Collection
Periodontitis is a major public health problem because it is widespread in the adult population. It leads to the irreversible destruction of the anchoring tissues of the teeth, and represents a modifiable risk factor for systemic inflammatory pathologies. This chronic inflammatory disease, which is associated with oral dysbiosis involving Porphyromonas gingivalis, is triggered by a permissive immune response. It is preceded by a reversible clinical phase, during which there is no bone resorption process: gingivitis. The understanding of the key mechanisms involved in the evolution from gingivitis to periodontitis, which will allow to early identify patient at risk of periodontitis, remain unclear at this time.
Neutrophils are the main cells of inflammation present within the periodontal pockets. The excess of certain neutrophils or the alteration of their functions is associated with the triggering of periodontitis, whereas their activity, finely orchestrated, would be a key to periodontal homeostasis. It is likely that some periodontal bacteria, including P. gingivalis, but also products of matrix catabolism could deregulate the physiological functions of neutrophils towards pro-inflammatory and catabolic profiles. Moreover, to date, the differentiation and role of neutrophil subsets in periodontal homeostasis as well as in gingivitis and its evolution into periodontitis remain poorly studied.
Read more
The investigators hypothesize that various subsets of neutrophils may play different roles during the development of periodontitis (evolution of gingivitis to periodontitis).
The primary objective is to characterize neutrophil subtypes associated with periodontal destruction during periodontitis.
Secondary objectives are :
- Identify specific interactions of tissue-activated neutrophils with the matrix microenvironment during periodontitis
- Identify specific interactions of tissue or oral (salivary) activated neutrophils with the oral microbiota during periodontitis
- Identify specific oral (salivary) neutrophil subtypes in periodontal health, gingivitis and periodontitis
- Evaluate the function, including pro-osteoclastogenic function, of oral neutrophils compared to blood neutrophils stimulated by infection
Read the detailed description
It's a cross-sectional, monocenter prospective, open-label, non randomized case control study to collect tissue, crevicular, salivary, and serum samples as part of the patient's routine care in oral medicine departments to form a biological collection. The samples and the clinical data of the patients.
Patients will be recruited in the oral medicine departments of AP-HP Charles Foix hospital (Ivry/seine) by periodontists in three groups (Cases : Group 1 : Gingivitis, Group 2 : Periodontitis, and Controls = healthy periodontium. All patients will require surgical care).
The time-line of the research is consistent with the usual patient management in oral medicine departments. Inclusion period is 36 months. There is no specific follow-up due to the research. Gingival tissue sampling during surgery of patients will be performed after their inclusion.
Assessment Criteria :
- Neutrophil subtypes analysis based on co-expression of neutrophil function markers from a panel of 24 markers by imaging on sections.
- Identification by immunohistofluorescence (on tissues) of the expression of matrix proteins described as regulating neutrophil function, and search of co-location between these proteins and certain neutrophil subtypes.
- Identification by immunohistofluorescence (on tissue) of key bacteria of oral dysbiosis in periodontitis, and search for co-localization between these bacteria and certain neutrophil subtypes.
- Assessment of neutrophil sub-types present in the patient's saliva and study of the correlation within tissue neutrophils during periodontal health, gingivitis and periodontitis.
- Differentiation and activity of osteoclasts in co-culture with isolated oral /blood neutrophils in patients.
- Conditions
- Periodontitis
- Being tested
- Biological sampling in Periodontitis Case, Biological sampling in Gingivitis Case, Biological sampling in Control Case
- Keywords
- Periodontitis, Gingivitis, Neutrophils, Subsets, Biological collection
- Medical subject headings
- Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sampling in Periodontitis CaseOther
Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection;
J+7 : tooth extraction : gingival explant sampling
J+15 : Healing control
Biological sampling in Gingivitis CaseOther
Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection;
J+7 : tooth extraction or pre-prosthetic periodontal surgeries : gingival explant sampling
J+15 : Healing control
Biological sampling in Control CaseOther
Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection;
J+7 : tooth extraction or pre-prosthetic periodontal surgeries : gingival explant sampling
J+15 : Healing control
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis Cases | Patients with stage 3 or 4 periodontitis (Chicago 2017) ; BOP ≥ 10%, PD≥ 4mm Patients requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries Receives: Other: Biological sampling in Periodontitis Case | |
| Gingivitis Cases | BOP ≥ 10%, PD≤ 3mm according to Chicago 2017 Patients requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries Receives: Other: Biological sampling in Gingivitis Case | |
| Control | BOP < 10%, PD≤ 3mm Patients with gingival health on intact or reduced periodontium without a history of periodontitis and requiring surgical care such as dental avulsion or aesthetic surgeries Receives: Other: Biological sampling in Control Case |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of neutrophil subtypes associated with periodontal destruction in periodontitis based on coexpression of markers of neutrophil function .
Distinction of neutrophil subtypes based on coexpression of markers of neutrophil function from a panel of 24 markers by imaging on tissue sections
Measured: 36 months
Secondary outcomes (7)
Identify specific interactions of activated tissue neutrophils with the matrix microenvironment during periodontitis using Immunohistofluorescence identification of the expression of some matrix proteins.
Immunohistofluorescence identification (on tissue) of the expression of matrix proteins described as regulators of neutrophil function, and search for co-localization between said proteins/peptides and certain subtypes of neutrophils
Measured: 36 months
Identify interactions of activated tissue or oral neutrophils with the oral microbiota using Immunohistofluorescence identification of key bacteria and investigation of co-localization between bacteria and certain subtypes of neutrophils
Immunohistofluorescence identification (on tissue) of key bacteria in oral dysbiosis during periodontitis and investigation of co-localization between bacteria and certain subtypes of neutrophils
Measured: 36 months
Describe oral (salivary) neutrophil subtypes during periodontal health, gingivitis and periodontitis based on coexpression of markers of neutrophil function.
Evaluation of neutrophil subtypes present in patient saliva and study of correlation with tissue neutrophils during periodontal health, gingivitis and periodontitis
Measured: 36 months
Evaluate the differenciation, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection using morphological criteria like the number of nuclei and cell size
osteoclast differentiation will be analyzed using morphological criteria, like the number of nuclei
Measured: 36 months
Evaluate the differenciation, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection using morphological criteria like the cell size
osteoclast differentiation will be analyzed using morphological criteria, like cell size
Measured: 36 months
Evaluate the activity, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection, using functional criteria such as resorption activity (size of lacunae formed by the cells on culture dishes)
Osteoclast activity will be assessed by functional criteria such as resorption activity (size of lacunae formed by the cells on specific culture dishes)
Measured: 36 months
Evaluate the activity, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection, using functional criteria such as expression of activity markers by Trap staining
Osteoclast activity will be assessed by functional criteria such as expression of activity markers (Trap staining)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start30 Apr 2025
- Primary completion15 May 2028 (estimated)
- Study completion15 May 2028 (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 Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjolaine Gosset, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012019
- Sponsor's protocol ID
- APHP230385
- Acronym
- CB-PARO2
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Immuno-inflammatory Response Involved in Bone Destruction During Periodontitis: Study on Biological Samples With Collection
- ClinicalTrials.gov ID
- NCT06012019
- Acronym / sponsor ID
- CB-PARO2 / APHP230385
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Gingivitis, Neutrophils, Subsets, Biological collection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 25 Aug 2023 (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.
Periodontitis is a major public health problem because it is widespread in the adult population. It leads to the irreversible destruction of the anchoring tissues of the teeth, and represents a modifiable risk factor for systemic inflammatory pathologies. This chronic inflammatory disease, which is associated with oral dysbiosis involving Porphyromonas gingivalis, is triggered by a permissive immune response. It is preceded by a reversible clinical phase, during which there is no bone resorption process: gingivitis. The understanding of the key mechanisms involved in the evolution from gingivitis to periodontitis, which will allow to early identify patient at risk of periodontitis, remain unclear at this time.
Neutrophils are the main cells of inflammation present within the periodontal pockets. The excess of certain neutrophils or the alteration of their functions is associated with the triggering of periodontitis, whereas their activity, finely orchestrated, would be a key to periodontal homeostasis. It is likely that some periodontal bacteria, including P. gingivalis, but also products of matrix catabolism could deregulate the physiological functions of neutrophils towards pro-inflammatory and catabolic profiles. Moreover, to date, the differentiation and role of neutrophil subsets in periodontal homeostasis as well as in gingivitis and its evolution into periodontitis remain poorly studied.
The investigators hypothesize that various subsets of neutrophils may play different roles during the development of periodontitis (evolution of gingivitis to periodontitis).
The primary objective is to characterize neutrophil subtypes associated with periodontal destruction during periodontitis.
Secondary objectives are :
- Identify specific interactions of tissue-activated neutrophils with the matrix microenvironment during periodontitis
- Identify specific interactions of tissue or oral (salivary) activated neutrophils with the oral microbiota during periodontitis
- Identify specific oral (salivary) neutrophil subtypes in periodontal health, gingivitis and periodontitis
- Evaluate the function, including pro-osteoclastogenic function, of oral neutrophils compared to blood neutrophils stimulated by infection
Detailed description
It's a cross-sectional, monocenter prospective, open-label, non randomized case control study to collect tissue, crevicular, salivary, and serum samples as part of the patient's routine care in oral medicine departments to form a biological collection. The samples and the clinical data of the patients.
Patients will be recruited in the oral medicine departments of AP-HP Charles Foix hospital (Ivry/seine) by periodontists in three groups (Cases : Group 1 : Gingivitis, Group 2 : Periodontitis, and Controls = healthy periodontium. All patients will require surgical care).
The time-line of the research is consistent with the usual patient management in oral medicine departments. Inclusion period is 36 months. There is no specific follow-up due to the research. Gingival tissue sampling during surgery of patients will be performed after their inclusion.
Assessment Criteria :
- Neutrophil subtypes analysis based on co-expression of neutrophil function markers from a panel of 24 markers by imaging on sections.
- Identification by immunohistofluorescence (on tissues) of the expression of matrix proteins described as regulating neutrophil function, and search of co-location between these proteins and certain neutrophil subtypes.
- Identification by immunohistofluorescence (on tissue) of key bacteria of oral dysbiosis in periodontitis, and search for co-localization between these bacteria and certain neutrophil subtypes.
- Assessment of neutrophil sub-types present in the patient's saliva and study of the correlation within tissue neutrophils during periodontal health, gingivitis and periodontitis.
- Differentiation and activity of osteoclasts in co-culture with isolated oral /blood neutrophils in patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontitis Cases | – | Other: Biological sampling in Periodontitis CasePatients with stage 3 or 4 periodontitis (Chicago 2017) ; BOP ≥ 10%, PD≥ 4mm Patients requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries |
| Gingivitis Cases | – | Other: Biological sampling in Gingivitis CaseBOP ≥ 10%, PD≤ 3mm according to Chicago 2017 Patients requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries |
| Control | – | Other: Biological sampling in Control CaseBOP < 10%, PD≤ 3mm Patients with gingival health on intact or reduced periodontium without a history of periodontitis and requiring surgical care such as dental avulsion or aesthetic surgeries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns adult patients consulting the oral medicine department at Hôpital Charles Foix (AP-HP, Ivry sur Seine) Cases : * Group 1 = Patients should have bacterial gingivitis * Group 2 = Patients should have stage 3 or 4 localized or generalized bacterial periodontitis. The diagnosis of gingivitis or periodontitis is based on the elements noted during the clinical interview and examination, in accordance with the Chicago 2017 classification. Control: Patient with healthy gingiva on intact or reduced periodontium with no history of periodontitis, in accordance with the Chicago 2017 classification.
Key inclusion criteria (9 listed)
- Common criteria for all patient groups
- Patient > 18 years old
- Patient affiliated to a national health insurance
- Patient who speaks and understands French well enough to be able to read and understand the study information note.
- Patient who does not object to his participation in the study
Key exclusion criteria (4 listed)
- Patients who have received antibiotic prophylaxis, antibiotic therapy, or anti-inflammatory treatment within 3 months prior to inclusion
- Pregnant or breastfeeding women
- Patients suffering from a disease with defective neutrophil number, activity, activation or function
- Patient deprived of liberty by judicial or administrative decision.
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 |
|---|---|---|
| Biological sampling in Periodontitis CasePeriodontal bacteria, gingival fluid, unstimulated saliva and blood collection; J+7 : tooth extraction : gingival explant sampling J+15 : Healing control | Other | Periodontitis Cases |
| Biological sampling in Gingivitis CasePeriodontal bacteria, gingival fluid, unstimulated saliva and blood collection; J+7 : tooth extraction or pre-prosthetic periodontal surgeries : gingival explant sampling J+15 : Healing control | Other | Gingivitis Cases |
| Biological sampling in Control CasePeriodontal bacteria, gingival fluid, unstimulated saliva and blood collection; J+7 : tooth extraction or pre-prosthetic periodontal surgeries : gingival explant sampling J+15 : Healing control | Other | Control |
Primary outcome
Description of neutrophil subtypes associated with periodontal destruction in periodontitis based on coexpression of markers of neutrophil function .
Time frame: 36 months
Distinction of neutrophil subtypes based on coexpression of markers of neutrophil function from a panel of 24 markers by imaging on tissue sections
7 secondary outcomes
Identify specific interactions of activated tissue neutrophils with the matrix microenvironment during periodontitis using Immunohistofluorescence identification of the expression of some matrix proteins.
Time frame: 36 months
Identify interactions of activated tissue or oral neutrophils with the oral microbiota using Immunohistofluorescence identification of key bacteria and investigation of co-localization between bacteria and certain subtypes of neutrophils
Time frame: 36 months
Describe oral (salivary) neutrophil subtypes during periodontal health, gingivitis and periodontitis based on coexpression of markers of neutrophil function.
Time frame: 36 months
Evaluate the differenciation, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection using morphological criteria like the number of nuclei and cell size
Time frame: 36 months
Evaluate the differenciation, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection using morphological criteria like the cell size
Time frame: 36 months
Evaluate the activity, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection, using functional criteria such as resorption activity (size of lacunae formed by the cells on culture dishes)
Time frame: 36 months
Evaluate the activity, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection, using functional criteria such as expression of activity markers by Trap staining
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Marjolaine Gosset, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
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 Assistance Publique - Hôpitaux de Paris 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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marjolaine Gosset, PU-PH (01 49 59 48 11, marjolaine.gosset@u-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of neutrophil subtypes associated with periodontal destruction in periodontitis based on coexpression of markers of neutrophil function . (time frame: 36 months). 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 24 Aug 2025.