Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06789458
Status:
RECRUITING
Last Update Posted:
2025-01-23
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Pro-Resolution Mediator Levels in Periodontitis Stage III and IV Before and After Periodontal Therapy
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Assessment of Pro-Resolution Mediator Levels in Periodontitis Stage III and IV Before and After Periodontal Therapy
Status:
RECRUITING
Status Verified Date:
2025-01
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:
None
Brief Summary:
This study aims to assess Pro-Resolution Mediator levels during non-surgical periodontal therapy in individuals with Stage III and IV periodontitis, comparing them to healthy subjects. Periodontitis, a chronic inflammatory condition affecting tooth-supporting tissues, can lead to tooth loss and systemic complications. Understanding the role of pro-resolving lipid mediators in inflammation resolution may offer insights into therapeutic benefits associated with these mediators.
Detailed Description:
Periodontitis is a chronic inflammatory disease that affects the tooth-supporting tissues, it produces a slow destruction of the periodontium that may eventually result in tooth loss. Periodontitis is caused by a dysbiosis of the immune system where there is an imbalance between the processes that activate and terminate the inflammatory process.(Van Dyke, 2020) Pro-resolving lipid mediators (PMs) play a key role in actively resolving inflammation, modulating immune responses, and promoting tissue healing. However, the understanding of PMs in periodontitis and their role in the enduring nature of the disease has not been sufficiently studied in a clinical setting. It has been suggested that PM levels vary between periodontitis patients and healthy individual with periodontal therapy potentially restoring the balance between pro- and anti-inflammatory mediators. (Van Dyke, 2017) The study aims to provide insights into inflammation resolution mechanisms in periodontitis and the therapeutic potential of PMs.
This study aims to Assess Pro-Resolution Mediator Levels During Periodontal Therapy in Patients with Periodontitis Stage III and IV compared to healthy patients.
Hypothesis Null Hypothesis: pro-resolution mediators' level before and after non-surgical treatment in stage III and IV periodontitis compared to healthy patients, there will be no difference in level before and after non-surgical treatment between stage III and IV periodontitis compared to healthy patients.
Trial design:
The current study design is a before and after trial with a single (interventional) population measured before and after treatment compared to a negative control of healthy patients.
This study aims to Assess Pro-Resolution Mediator Levels During Periodontal Therapy in Patients with Periodontitis Stage III and IV compared to healthy patients.
Hypothesis Null Hypothesis: pro-resolution mediators' level before and after non-surgical treatment in stage III and IV periodontitis compared to healthy patients, there will be no difference in level before and after non-surgical treatment between stage III and IV periodontitis compared to healthy patients.
Trial design:
The current study design is a before and after trial with a single (interventional) population measured before and after treatment compared to a negative control of healthy patients.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: