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NCT Number: NCT06012019

Periodontitis and Inflammation: Study on Biological Samples

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 :

1. Identify specific interactions of tissue-activated neutrophils with the matrix microenvironment during periodontitis 2. Identify specific interactions of tissue or oral (salivary) activated neutrophils with the oral microbiota during periodontitis 3. Identify specific oral (salivary) neutrophil subtypes in periodontal health, gingivitis and periodontitis 4. Evaluate the function, including pro-osteoclastogenic function, of oral neutrophils compared to blood neutrophils stimulated by infection

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Key information

Conditions

Periodontitis Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 :

  • Control Group = BOP < 10%, PI<20%, PD≤ 3mm
  • Gingivitis cases = BOP ≥ 10%, PD≤ 3mm
  • Periodontitis cases = BOP ≥ 10%, PD> 3mm

Exclusion criteria

  • 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.

Treatment and study plan

Biological sampling in Periodontitis Case

Other

Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection;

J+7 : tooth extraction : gingival explant sampling

J+15 : Healing control

Biological sampling in Gingivitis Case

Other

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 Case

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. 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

    Immunohistofluorescence identification (on tissue) of key bacteria in oral dysbiosis during periodontitis and investigation of co-localization between bacteria and certain subtypes of neutrophils

  3. Describe oral (salivary) neutrophil subtypes during periodontal health, gingivitis and periodontitis based on coexpression of markers of neutrophil function.

    Time frame: 36 months

    Evaluation of neutrophil subtypes present in patient saliva and study of correlation with tissue neutrophils during periodontal health, gingivitis and periodontitis

  4. 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

    osteoclast differentiation will be analyzed using morphological criteria, like the number of nuclei

  5. 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

    osteoclast differentiation will be analyzed using morphological criteria, like cell size

  6. 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

    Osteoclast activity will be assessed by functional criteria such as resorption activity (size of lacunae formed by the cells on specific culture dishes)

  7. 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

    Osteoclast activity will be assessed by functional criteria such as expression of activity markers (Trap staining)

Study contacts

Contact information is provided by the study sponsor or research team.

François Ferré, MCU-PH

CONTACT

franç[email protected]

01 49 59 48 11

Marjolaine Gosset, PU-PH

CONTACT

[email protected]

01 49 59 48 11

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Characterization of the Immuno-inflammatory Response Involved in Bone Destruction During Periodontitis: Study on Biological Samples With Collection

Acronym: CB-PARO2

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2023
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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