Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04831060
Status:
RECRUITING
Last Update Posted:
2023-02-21
First Post:
2021-03-25
Brief Title:
Periodontitis and Inflammation
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Characterization of the Immuno-inflammatory Response Involved in Bone Destruction During Periodontitis Study With Biological Collection
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CB-PARO
Brief Summary:
Today to understand pathogenic mechanisms involved in periodontitis remains a challenge to identify biomarkers or therapeutic targets to improve prevention and screening as well as the effectiveness of periodontitis 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
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 stage 3 or 4 versus patients with a healthy periodontium Biological samples will be collected before and all along the periodontal 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 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 versus without periodontitis 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
improve the knowledge of the pathogenesis of periodontitis
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 stage 3 or 4 versus patients with a healthy periodontium Biological samples will be collected before and all along the periodontal 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 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 versus without periodontitis 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 remains a challenge to identify biomarkers or therapeutic targets to improve prevention and screening as well as the effectiveness of periodontitis 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
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 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 patients 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 UR2496 for their analysis
Patients will be recruited in the oral medicine departments of AP-HP hospitals Charles Foix Ivryseine and Henri Mondor Créteil by periodontists in two groups cases periodontitis 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 12 months There is no specific follow-up due to the research
Gingival tissue sampling during surgery of patients will be performed after their inclusion
improve the knowledge of the pathogenesis of periodontitis
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 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 patients 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 UR2496 for their analysis
Patients will be recruited in the oral medicine departments of AP-HP hospitals Charles Foix Ivryseine and Henri Mondor Créteil by periodontists in two groups cases periodontitis 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 12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None