Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443372
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
GCF Bax and Bcl-xl Levels in Periodontitis
Sponsor:
Aydin Adnan Menderes University
Organization:
Aydin Adnan Menderes University
Study Overview
Official Title:
Gingival Crevicular Fluid Levels of Apoptotic Regulatory Proteins Bax and Bcl-xl in Stage III Periodontitis
Status:
COMPLETED
Status Verified Date:
2024-05
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:
Intrinsic apoptosis pathway plays a critical role in the host immune defense and inflammation and its dysregulation is involved in various chronic diseases Bcl-2 protein family primarly mediates this mitochondrial pathway This study aimed to investigate the pro-apoptotic Bax and anti-apoptotic Bcl-xl levels and their association with interleukin-22 IL-22 and transforming growth factor-beta 1 TGF-β1 in gingival crevicular fluid GCF of patients with periodontitis In total 75 systemically healthy and non-smoker individuals consisting of stage III periodontitis n23 gingivitis n26 periodontally healthy n26 were enrolled Whole-mouth clinical periodontal measurements were recorded Bax Bcl-xl IL-22 and TGF-β1 levels in GCF were determined by ELISA Data were analyzed using non-parametric statistical tests
Detailed Description:
According to the 2017 World Workshop on the Classification of Periodontal and Peri-implant Diseases and Conditions participants were categorized into three groups
I Periodontitis group n23 II Gingivitis group n26 III Periodontally healthy group n26
Clinical periodontal measurements included probing depth PD clinical attachment loss CAL the dichotomous scoring of bleeding on probing BOP - gingival index GI and plaque index PI All clinical parameters were recorded at six points mesiobuccal buccal distobuccal mesiopalatalmesiolingual palatallingual and distopalataldistolingual per tooth except the 3rd molars by a single investigator CÖ using a manual periodontal probe
The percentage of radiographic bone loss RBL at the interproximal sites were calculated on the digital panoramic radiographs as the ratio of the distance between bone level and the cemento-enamel junction to the length of the root
GCF samples were obtained 1 day following the clinical periodontal measurements GCF was collected from the buccal aspects of non-contiguous interproximal sites in two single-rooted teeth via steril paper strips Fluid samples were obtained from two deepest pockets in periodontitis group and the most inflamed sites with clinical signs of redness or edema in gingivitis group In the periodontally healthy groups samples were taken from the sites without visible inflammation All samples were stored at -80 C until further analysis
Measurements of Bax Bcl-xl IL-22 and TGF-β1 levels in GCF samples were performed by the commercially available enzyme-linked immunosorbent assay ELISA kits GCF molecule levels were expressed as total amounts at two samples per 30 s
A statistical software package was used for all data analyses The distribution of clinical and biochemical data was checked by Shapiro-Wilks normality test Since the data were not normally distributed the differences between study groups in clinical measurements and GCF levels of Bax Bcl-xl IL-22 and TGF-β1 were compared by the Kruskal-Wallis non-parametric test with the Dunn-Bonferroni post hoc method Spearman rank correlation analysis was performed to evaluate the correlations of four protein levels in GCF with clinical parameters p005 was considered as statistically significant
I Periodontitis group n23 II Gingivitis group n26 III Periodontally healthy group n26
Clinical periodontal measurements included probing depth PD clinical attachment loss CAL the dichotomous scoring of bleeding on probing BOP - gingival index GI and plaque index PI All clinical parameters were recorded at six points mesiobuccal buccal distobuccal mesiopalatalmesiolingual palatallingual and distopalataldistolingual per tooth except the 3rd molars by a single investigator CÖ using a manual periodontal probe
The percentage of radiographic bone loss RBL at the interproximal sites were calculated on the digital panoramic radiographs as the ratio of the distance between bone level and the cemento-enamel junction to the length of the root
GCF samples were obtained 1 day following the clinical periodontal measurements GCF was collected from the buccal aspects of non-contiguous interproximal sites in two single-rooted teeth via steril paper strips Fluid samples were obtained from two deepest pockets in periodontitis group and the most inflamed sites with clinical signs of redness or edema in gingivitis group In the periodontally healthy groups samples were taken from the sites without visible inflammation All samples were stored at -80 C until further analysis
Measurements of Bax Bcl-xl IL-22 and TGF-β1 levels in GCF samples were performed by the commercially available enzyme-linked immunosorbent assay ELISA kits GCF molecule levels were expressed as total amounts at two samples per 30 s
A statistical software package was used for all data analyses The distribution of clinical and biochemical data was checked by Shapiro-Wilks normality test Since the data were not normally distributed the differences between study groups in clinical measurements and GCF levels of Bax Bcl-xl IL-22 and TGF-β1 were compared by the Kruskal-Wallis non-parametric test with the Dunn-Bonferroni post hoc method Spearman rank correlation analysis was performed to evaluate the correlations of four protein levels in GCF with clinical parameters p005 was considered as statistically significant
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