Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 1:21 PM
Study NCT ID:
NCT06295666
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2024-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gingival Crevicular Fluid (GCF) Bactericidal Permeability Protein (BPI) and Interleukin (IL)-1 Beta
Sponsor:
Akdeniz University
Organization:
Study Overview
Official Title:
Gingival Crevicular Fluid(GCF) Bactericidal Permeability Protein (BPI) and Interleukin(IL)-1 Beta Levels and Relationship With Periodontal Disease
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Objective: The aim of this study is to determine the amounts of BPI (Bactericidal permeability protein) and interleukin-1beta (IL-1β) in gingival fluid samples obtained from individuals with periodontally healthy and periodontal disease, to compare these amounts between study groups, and to evaluate their relationship with clinical parameters. In cases where clinical parameters increase, IL-1β amounts also increase significantly. The amount of IL-1β in individuals with periodontal disease is significantly higher compared to healthy individuals. There is positive correlation between BPI and clinical parameters. The amount of BPI in individuals with periodontal disease is significantly higher than in healthy individuals. More studies are needed to better understand the importance and therapeutic effect of BPI in periodontitis
Detailed Description:
Systemically healthy and non-smoking participants were included in the study. The study groups included a total of 100 participants, 50 of whom were periodontally healthy (healthy group) and 50 with periodontal disease (periodontitis) group). The clinical parameters of plaque index (PI), gingival index (GI), and pocket depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) were measured.
The gingival fluid samples were taken in the direction of the paper strip and ELISA method was used for their analysis. A positive, statistically significant relationship was found between IL-1β levels and all clinical parameters (PI, GI, PD, CAL, BOP) (p\<0,01). Likewise, there is a positive and significant relationship between BPI levels and clinical parameters (p\<0,01).
There is a statistically significant positive correlation between GCF volume and clinical parameters PI (r: 0,722), GI (r: 0,740), PD (r: 0,742), CAL (r: 0,751) and BOP (r: 0.752) (p \< 0.01). In the comparison between the groups, it is seen that both IL-1β and BPI levels were statistically significantly higher in the periodontitis group compared to the healthy group (p \< 0,001).
The gingival fluid samples were taken in the direction of the paper strip and ELISA method was used for their analysis. A positive, statistically significant relationship was found between IL-1β levels and all clinical parameters (PI, GI, PD, CAL, BOP) (p\<0,01). Likewise, there is a positive and significant relationship between BPI levels and clinical parameters (p\<0,01).
There is a statistically significant positive correlation between GCF volume and clinical parameters PI (r: 0,722), GI (r: 0,740), PD (r: 0,742), CAL (r: 0,751) and BOP (r: 0.752) (p \< 0.01). In the comparison between the groups, it is seen that both IL-1β and BPI levels were statistically significantly higher in the periodontitis group compared to the healthy group (p \< 0,001).
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?:
None
Is an FDA AA801 Violation?: