Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06110221 |
Other study ID # |
Activin-A |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 22, 2019 |
Est. completion date |
February 2, 2020 |
Study information
Verified date |
October 2023 |
Source |
Aydin Adnan Menderes University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Activin-A belongs to the transforming growth factor-beta superfamily and is a multifunctional
cytokine that plays a role in inflammation, immune response, tissue repair and regeneration.
Proinflammatory cytokine interleukin-1beta (IL-1β) can increase Activin-A expression in
various cell types. This study aims to evaluate gingival crevicular fluid (GCF) and salivary
Activin-A and IL-β levels in stage III periodontitis. Seventy-five systemically healthy and
non-smoker volunteers consisting of 23 stage III periodontitis, 26 gingivitis and 26
periodontally healthy were enrolled. Full-mouth clinical periodontal indices were recorded,
unstimulated whole saliva and GCF samples were obtained, Activin-A and IL-1β total amounts
were determined by enzyme-linked immunosorbent assay. Statistical comparisons were performed
using non-parametric tests.
Description:
Participants were divided into three groups according to the diagnostic criteria proposed by
the Classification of Periodontal and Peri-implant Diseases and Conditions; I. Periodontitis
group (n=23), II. Gingivitis group (n=26) III. Periodontally healthy group (n=26)
Clinical periodontal indices included probing depth (PD), clinical attachment loss (CAL), the
dichotomous scoring of bleeding on probing (BOP +/-), gingival index (GI), and plaque index
(PI). Clinical recordings were performed at six points (mesiobuccal, buccal, distobuccal,
mesiopalatal/mesiolingual, palatal/lingual, and distopalatal/distolingual) of all teeth,
except the 3rd molars, by a single investigator using a conventional periodontal probe.
Interproximal radiographic bone loss on the digital panoramic radiographs were evaluated, as
the ratio of the distance between the bone crest and the cemento-enamel junction to the
length of the root.
GCF and unstimulated whole saliva samples were obtained 1 day following the clinical
periodontal measurements. Immediately after saliva collection, 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.
Measurement of Activin-A and IL-1β levels in GCF and saliva samples were performed by the
commercially available enzyme-linked immunosorbent assay (ELISA) kits. While GCF cytokine
levels were expressed as both total amounts at two samples per 30 s and concentrations,
salivary cytokine levels were presented as concentrations.
A statistical software package was used for all data analyses. If the clinical and
biochemical data did not present normal distribution as checked by Shapiro Wilk's normality
test, the analyses were performed by using nonparametric methods. The Kruskal-Wallis test
with Dunn-Bonferroni post hoc method was applied to compare the study groups regarding
clinical indices and oral biofluid levels of Activin-A and IL-1β. The presence and degree of
linear association of cytokine levels in GCF and saliva with clinical indices were analyzed
by Spearman rank correlation coefficient. p<0.05 was considered as a threshold for
statistical significance.