PeriodontitisCB-PARONCT04831060
Periodontitis and Inflammation
An observational study of Periodontitis and Peri-Implantitis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Today, to understand pathogenic mechanisms involved in periodontitis and peri-implantitis remains a challenge to identify biomarkers or therapeutic targets to improve prevention and screening, as well as the effectiveness of periodontitis and peri-implantitis treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Peri-Implantitis
- What is being tested?
- Periodontal or peri-implantitis treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 219 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Feb 2023to 15 Nov 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 departments of Hôpital Charles Foix (AP-HP, Ivry sur Seine) and Hôpital Rothschild (AP-HP, Paris) - Patients: Patients should have: - localized or generalized periodontitis of stage 3 or 4. The diagnosis of periodontitis is based on the elements noted during the interview and the clinical examination. Or * at least 1 implant with peri-implantitis. The diagnosis is based on the findings of the interview, clinical examination and radiographic examination. * Controls: Patients with gingival health on intact or reduced periodontium with no history of periodontitis and requiring surgical care such as dental avulsion and pre-prosthetic periodontal corrective/aesthetic surgeries (coronal elongation, neck alignment
Who may be able to join
- Common criteria for all patient groups
- Patient > 18 years old
- Patient affiliated to a social security system, beneficiary or beneficiary of a right other than AME
- 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 10Show fewer
- Case Periodontitis: Patient with localized or generalized periodontitis, stage 3 or 4. The diagnosis of periodontitis is based on the elements found during the interview and clinical examination
- Case peri-implantitis: Patients with at least 1 implant affected by peri-implantitis. Diagnosis is based on the findings of the interview, clinical examination and radiographic examination.
- Control group:
- Patient with gingival health on intact or reduced periodontium with no history of periodontitis or peri-implantitis and requiring surgical care such as dental avulsion and pre-prosthetic periodontal corrective/aesthetic surgeries (coronal elongation, neck alignment.)
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
- Patient included in another interventional research protocol or in a period of exclusion.
- Patients under guardianship, curatorship or legal protection.
- Patient having expressed his opposition to participate in the research
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Service d'odontologie, hôpital Charles Foix
Ivry-sur-Seine, 94200
Marjolaine GOSSET, MD,PhD, 01 49 59 48 11 ext. +33, marjolaine.gosset@aphp.fr
- Recruiting
Dentistry department- Rothschild hospital
Paris, 75012
Marjolaine GOSSET, MD,PhD, marjoilaine.gosset@aphp.fr
About this study
Official title: Characterization of the Immuno-inflammatory Response Involved in Bone Destruction During Periodontitis: Study With Biological Collection
Today, to understand pathogenic mechanisms involved in periodontitis and peri-implantitis remains a challenge to identify biomarkers or therapeutic targets to improve prevention and screening, as well as the effectiveness of periodontitis and peri-implantitis treatments. The aim is to characterize, in vivo, specific molecular markers reflecting the activity of the pathology, which could lead to
- improve the knowledge of the pathogenesis of periodontitis and peri-implantitis;
- determine target molecules involved in tissue destruction;
- determine molecular profiles of patients at local and systemic risk;
- determine therapeutic targets
Read more
For this purpose, biological samples will be collected (plaque, saliva, crevicular fluid) from patients with periodontitis or peri-implantitis stage 3 or 4 versus patients with a healthy periodontium. Biological samples will be collected before and all along the periodontal or peri-implantal treatment. Gingiva explants collection will be sampling within the surgical procedures (if they are needed).
The primary objective is to investigate tissue and cellular expression of molecular markers associated with periodontal destruction during periodontitis or peri-implantitis in relation to periodontal infection and systemic changes in host response. A characterization of the cytokines in gingival fluid and unstimulated saliva (Luminex® technique) of patients with periodontitis or peri-implantitis versus without periodontitis or peri-implantitis will be done.
The secondary objective is to study the influence of periodontitis on systemic pathologies via serum analysis of molecules and bacteria involved in periodontal destruction. Immunofluorescence evaluation of protein expression and distribution (inflammatory mediators, inflammatory pathway signaling proteins) in gingival explants, characterization of proteases (MMP) present in gingival fluid and unstimulated saliva (Luminex® technique) and microbiological analysis of the subgingival biofilm (by quantitative PCR).
Read the detailed description
Today, to understand pathogenic mechanisms involved in periodontitis and peri-implantitis remains a challenge to identify biomarkers or therapeutic targets to improve prevention and screening, as well as the effectiveness of periodontitis and peri-implantitis treatments. The aim is to characterize, in vivo, specific molecular markers reflecting the activity of the pathology, which could lead to
- improve the knowledge of the pathogenesis of periodontitis and peri-implantitis;
- determine target molecules involved in tissue destruction;
- determine molecular profiles of patients at local and systemic risk;
- determine therapeutic targets
The research focuses on the characterization of the immuno-inflammatory response involved in periodontitis and peri-implantitis. A characterization of the mediators or cells involved will be performed from biological samples (gingival fluid, unstimulated saliva, gingival explants). The gingival fluid is composed of serum inflammatory exudate and inflammatory mediators produced locally in the periodontal pocket. Unstimulated saliva is a biological fluid composed in part of the gingival fluid that drains into it. It has the advantage of being easier to collect (larger quantity, collection by any health professional).
This is a non-interventional, cross-sectional, multicenter, prospective, open-label, non-randomized 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 (excel file with anonymized data and locked by a password) will be transferred to UMR1333 for their analysis.
Patients will be recruited in the oral medicine departments of AP-HP hospitals (Charles Foix (Ivry/seine) and Rothschild (Paris) by periodontists in three groups (cases = periodontitis or peri-implantitis and controls = healthy periodontium but patients requiring surgical care).
The time-line of the research is consistent with the usual patient management in oral medicine departments. Inclusion period is 60 months. There is no specific follow-up due to the research.
Gingival tissue sampling during surgery of patients will be performed after their inclusion.
- Conditions
- Periodontitis, Peri-Implantitis
- Being tested
- Periodontal or peri-implantitis treatment, Control treatment
- Keywords
- Periodontitis, Inflammation, Cytokines, Diabetes Mellitus, peri-implantitis
- Medical subject headings
- Periodontitis, Peri-Implantitis, Inflammation, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal or peri-implantitis treatmentProcedure or surgery
Also called Scaling and root planning, periodontal debridement, periodontal or peri-implantal surgery, open flap debridement
For Cases :
- Inclusion; Bacterial sampling, gingival fluid and unstimulated saliva collection; Teaching of oral hygiene techniques.
- Non-surgical periodontal or peri-implantal treatment
- At 3 months = periodontal or peri-implantal reevaluation; Bacterial sampling, gingival fluid and unstimulated saliva collection
- If periodontal or peri-implantal pockets greater than 5mm and bleeding persist: surgery and gingival explant sampling
- At 3 months post-surgery = periodontal or peri-implantal re-evaluation; Bacterial sampling, gingival fluid and unstimulated saliva collection
- Maintenance
Control treatmentProcedure or surgery
For Controls:
- Inclusion; Bacterial sampling, gingival fluid and unstimulated saliva collection, teaching of oral hygiene techniques.
- Plastic or pre-prosthetic surgery = gingival explant sampling
- Healing control at 15 days
| Study group | Role | What they receive |
|---|---|---|
| Case Periodontitis | Patients with stage 3 or 4 periodontitis Receives: Procedure: Periodontal or peri-implantitis treatment | |
| Case peri-implantitis | Patients should present at least 1 implant with peri-implantitis Receives: Procedure: Periodontal or peri-implantitis treatment | |
| Control (healthy periodontium) | Patients with gingival health on intact or reduced periodontium without a history of periodontitis or peri-implantitis and requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries or aesthetic surgeries Receives: Procedure: Control treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of a panel of cytokines in gingival fluid of patients with periodontitis versus without periodontitis
Analysis of gingival fluids and unstimulated saliva by the Luminex allows detection and quantification of 15 cytokines (IL- 1α, IL- 1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-15, IL-17, IL-18, IFN γ, TNF) simultaneously
Measured: 1 month once the collection is completed
Secondary outcomes (4)
Cytokines expression in periodontal cells
Analysis of cytokines, inflammation pathways and inflammation cells by histological analysis (immunofluorescence) of surgical specimens.
Measured: 6 months once the collection is completed
Cytokines expression in periodontal cells
Immunofluorescence evaluation of protein distribution (inflammatory mediators, inflammatory pathway signaling proteins) in gingival explants (confocal microscopy analysis).
Measured: 6 months once the collection is completed
Microbiological analysis of the subgingival biofilm determination of the percentage of periodontopathogens.
assessment through RT-PCR
Measured: 3 months once the collection is completed
Characterization of proteases (MMP) present in gingival fluid and unstimulated saliva
assessment through Luminex®
Measured: 1 month once the collection is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start15 Feb 2023
- Primary completion15 Nov 2028 (estimated)
- Study completion15 Nov 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831060
- Sponsor's protocol ID
- APHP200784
- Acronym
- CB-PARO
- Status last verified
- Jan 2026
- First submitted
- 25 Mar 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 21 Jan 2026. 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 With Biological Collection
- ClinicalTrials.gov ID
- NCT04831060
- Acronym / sponsor ID
- CB-PARO / APHP200784
- Conditions
- Periodontitis, Peri-Implantitis
- Keywords
- Periodontitis, Inflammation, Cytokines, Diabetes Mellitus, peri-implantitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Nov 2028 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 5 Apr 2021 (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.
Today, to understand pathogenic mechanisms involved in periodontitis and peri-implantitis remains a challenge to identify biomarkers or therapeutic targets to improve prevention and screening, as well as the effectiveness of periodontitis and peri-implantitis treatments. The aim is to characterize, in vivo, specific molecular markers reflecting the activity of the pathology, which could lead to
- improve the knowledge of the pathogenesis of periodontitis and peri-implantitis;
- determine target molecules involved in tissue destruction;
- determine molecular profiles of patients at local and systemic risk;
- determine therapeutic targets
For this purpose, biological samples will be collected (plaque, saliva, crevicular fluid) from patients with periodontitis or peri-implantitis stage 3 or 4 versus patients with a healthy periodontium. Biological samples will be collected before and all along the periodontal or peri-implantal treatment. Gingiva explants collection will be sampling within the surgical procedures (if they are needed).
The primary objective is to investigate tissue and cellular expression of molecular markers associated with periodontal destruction during periodontitis or peri-implantitis in relation to periodontal infection and systemic changes in host response. A characterization of the cytokines in gingival fluid and unstimulated saliva (Luminex® technique) of patients with periodontitis or peri-implantitis versus without periodontitis or peri-implantitis will be done.
The secondary objective is to study the influence of periodontitis on systemic pathologies via serum analysis of molecules and bacteria involved in periodontal destruction. Immunofluorescence evaluation of protein expression and distribution (inflammatory mediators, inflammatory pathway signaling proteins) in gingival explants, characterization of proteases (MMP) present in gingival fluid and unstimulated saliva (Luminex® technique) and microbiological analysis of the subgingival biofilm (by quantitative PCR).
Detailed description
Today, to understand pathogenic mechanisms involved in periodontitis and peri-implantitis remains a challenge to identify biomarkers or therapeutic targets to improve prevention and screening, as well as the effectiveness of periodontitis and peri-implantitis treatments. The aim is to characterize, in vivo, specific molecular markers reflecting the activity of the pathology, which could lead to
- improve the knowledge of the pathogenesis of periodontitis and peri-implantitis;
- determine target molecules involved in tissue destruction;
- determine molecular profiles of patients at local and systemic risk;
- determine therapeutic targets
The research focuses on the characterization of the immuno-inflammatory response involved in periodontitis and peri-implantitis. A characterization of the mediators or cells involved will be performed from biological samples (gingival fluid, unstimulated saliva, gingival explants). The gingival fluid is composed of serum inflammatory exudate and inflammatory mediators produced locally in the periodontal pocket. Unstimulated saliva is a biological fluid composed in part of the gingival fluid that drains into it. It has the advantage of being easier to collect (larger quantity, collection by any health professional).
This is a non-interventional, cross-sectional, multicenter, prospective, open-label, non-randomized 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 (excel file with anonymized data and locked by a password) will be transferred to UMR1333 for their analysis.
Patients will be recruited in the oral medicine departments of AP-HP hospitals (Charles Foix (Ivry/seine) and Rothschild (Paris) by periodontists in three groups (cases = periodontitis or peri-implantitis and controls = healthy periodontium but patients requiring surgical care).
The time-line of the research is consistent with the usual patient management in oral medicine departments. Inclusion period is 60 months. There is no specific follow-up due to the research.
Gingival tissue sampling during surgery of patients will be performed after their inclusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case Periodontitis | – | Procedure: Periodontal or peri-implantitis treatmentPatients with stage 3 or 4 periodontitis |
| Case peri-implantitis | – | Procedure: Periodontal or peri-implantitis treatmentPatients should present at least 1 implant with peri-implantitis |
| Control (healthy periodontium) | – | Procedure: Control treatmentPatients with gingival health on intact or reduced periodontium without a history of periodontitis or peri-implantitis and requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries 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 departments of Hôpital Charles Foix (AP-HP, Ivry sur Seine) and Hôpital Rothschild (AP-HP, Paris) - Patients: Patients should have: - localized or generalized periodontitis of stage 3 or 4. The diagnosis of periodontitis is based on the elements noted during the interview and the clinical examination. Or * at least 1 implant with peri-implantitis. The diagnosis is based on the findings of the interview, clinical examination and radiographic examination. * Controls: Patients with gingival health on intact or reduced periodontium with no history of periodontitis and requiring surgical care such as dental avulsion and pre-prosthetic periodontal corrective/aesthetic surgeries (coronal elongation, neck alignment
Key inclusion criteria (10 listed)
- Common criteria for all patient groups
- Patient > 18 years old
- Patient affiliated to a social security system, beneficiary or beneficiary of a right other than AME
- 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 (5 listed)
- Patients who have received antibiotic prophylaxis, antibiotic therapy, or anti-inflammatory treatment within 3 months prior to inclusion
- Pregnant or breastfeeding women
- Patient included in another interventional research protocol or in a period of exclusion.
- Patients under guardianship, curatorship or legal protection.
- Patient having expressed his opposition to participate in the research
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 |
|---|---|---|
| Periodontal or peri-implantitis treatmentAlso: Scaling and root planning, periodontal debridement, periodontal or peri-implantal surgery, open flap debridementFor Cases : * Inclusion; Bacterial sampling, gingival fluid and unstimulated saliva collection; Teaching of oral hygiene techniques. * Non-surgical periodontal or peri-implantal treatment * At 3 months = periodontal or peri-implantal reevaluation; Bacterial sampling, gingival fluid and unstimulated saliva collection * If periodontal or peri-implantal pockets greater than 5mm and bleeding persist: surgery and gingival explant sampling * At 3 months post-surgery = periodontal or peri-implantal re-evaluation; Bacterial sampling, gingival fluid and unstimulated saliva collection * Maintenance | Procedure or surgery | Case Periodontitis, Case peri-implantitis |
| Control treatmentFor Controls: * Inclusion; Bacterial sampling, gingival fluid and unstimulated saliva collection, teaching of oral hygiene techniques. * Plastic or pre-prosthetic surgery = gingival explant sampling * Healing control at 15 days | Procedure or surgery | Control (healthy periodontium) |
Primary outcome
Characterization of a panel of cytokines in gingival fluid of patients with periodontitis versus without periodontitis
Time frame: 1 month once the collection is completed
Analysis of gingival fluids and unstimulated saliva by the Luminex allows detection and quantification of 15 cytokines (IL- 1α, IL- 1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-15, IL-17, IL-18, IFN γ, TNF) simultaneously
4 secondary outcomes
Cytokines expression in periodontal cells
Time frame: 6 months once the collection is completed
Cytokines expression in periodontal cells
Time frame: 6 months once the collection is completed
Microbiological analysis of the subgingival biofilm determination of the percentage of periodontopathogens.
Time frame: 3 months once the collection is completed
Characterization of proteases (MMP) present in gingival fluid and unstimulated saliva
Time frame: 1 month once the collection is completed
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 21 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Peri-Implantitis, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 5 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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, Professor (+33 6 19 39 39 01, marjolaine.gosset@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of a panel of cytokines in gingival fluid of patients with periodontitis versus without periodontitis (time frame: 1 month once the collection is completed). 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 21 Jan 2026.