Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06443372 |
Other study ID # |
Apoptosis |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 22, 2019 |
Est. completion date |
April 12, 2024 |
Study information
Verified date |
May 2024 |
Source |
Aydin Adnan Menderes University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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 (n=23), gingivitis (n=26), periodontally healthy (n=26) 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.
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 (n=23), II. Gingivitis group (n=26) III. Periodontally healthy group
(n=26)
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, mesiopalatal/mesiolingual, palatal/lingual, and distopalatal/distolingual) per
tooth, except the 3rd molars, by a single investigator (C.Ö.) 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-Wilk's 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. p<0.05 was considered as statistically significant.