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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06012019
Other study ID # APHP230385
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 6, 2024
Est. completion date March 13, 2024

Study information

Verified date October 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Marjolaine Gosset, PU-PH
Phone 01 49 59 48 11
Email marjolaine.gosset@u-paris.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


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 : 1. Neutrophil subtypes analysis based on co-expression of neutrophil function markers from a panel of 24 markers by imaging on sections. 2. 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. 3. 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. 4. 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. 5. Differentiation and activity of osteoclasts in co-culture with isolated oral /blood neutrophils in patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date March 13, 2024
Est. primary completion date March 13, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Biological sampling in Periodontitis Case
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
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
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

Locations

Country Name City State
France Charles-Foix Hospital Ivry-sur-Seine

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 36 months
Secondary 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 36 months
Secondary 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 36 months
Secondary 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 36 months
Secondary 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 36 months
Secondary 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 36 months
Secondary 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) 36 months
Secondary 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) 36 months
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