Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05857436 |
Other study ID # |
Oral Microbiota |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 15, 2021 |
Est. completion date |
February 15, 2023 |
Study information
Verified date |
May 2023 |
Source |
Istanbul Medipol University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Aim: Apical periodontitis(AP) caused by root canal infection is the most frequent
pathological lesion in the jaws. Bacterial products, host immune cells and biologically
active factors called locally produced cytokines(such as IL-1, TNF-α) have been reported to
play an important role in the pathogenesis of AP. Metalloproteinases(MMP), is a measurable
biomarker that plays an important role in the degradation and regeneration of collagen and is
an indicator of collagen. This study aimed to determine the main bacterial species in the
microbiota as Gr(+) and Gr(-) and to compare the relationship between MMP-9 and TNF-α with
controlled patient groups. Methodology:60 patients with AP and extraction indication were
included in the study. 30 systemically and orally healthy volunteers were selected as the
control group. After access cavity preparation, an initial microbiologic sample(S1) was taken
from the root canal. After atraumatic extraction of the tooth, second microbial sample(S2)
was taken from the external root surface. After bacterial DNA extraction, 16S rRNA gene
primer was designed for sequence analysis. Bacterial community profiling was made by Sanger
sequencing of the PCR products. Besides, blood samples were collected from all of the
patients. Enzyme-linked immunosorbent assay was used to measure levels of MMP-9 and TNF-α.
Description:
60 patients with AP and extraction indication were included in the study. 30 systemically and
orally healthy volunteers were selected as the control group. After access cavity
preparation, an initial microbiologic sample(S1) was taken from the root canal. After
atraumatic extraction of the tooth, second microbial sample(S2) was taken from the external
root surface. After bacterial DNA extraction, 16S rRNA gene primer was designed for sequence
analysis. Bacterial community profiling was made by Sanger sequencing of the PCR products.
Besides, blood samples were collected from all of the patients. Enzyme-linked immunosorbent
assay was used to measure levels of MMP-9 and TNF-α Approximately 450 patients who applied to
xxxx University, Faculty of Dentistry, Endodontics Department for routine examination due to
apical periodontitis complaints were examined and their demographic characteristics were
recorded. Patients who had any acute or chronic inflammatory disease, known infection status,
history of trauma or surgical operation within 6 months that may affect MMP-9 levels,
pregnant and/or lactating, malignity, morbid obesity, arthritis, immunologic diseases,
cardiovascular diseases or use of vitamins with high biotin were not included in the study.
Additionally, patients who used antibiotics or anti-inflammatory drugs within the last 6
months, and patients with periodontal disease were excluded from the study. Of these
patients, 60 patients with AP and extraction indication (due to restorative causes and lesion
size) were included in the study. A total of 30 volunteers who were determined to be
systemically and orally healthy (not having AP indication), were included in the study as the
control group. The study was conducted between March 2022 and February 2023.
Demographic Characteristics & Clinical and Radiographic Evaluation Laboratory Analysis ELISA
measurement procedure of MMP-9 and TNF-α levels Bacteriological Sampling from the Root Canal
System and Outer Root Surface Genomic DNA Isolation and Measurement of DNA Concentration PCR
(16S Universal primer) Purification and sequencing of the 16S rRNA gene Power Analysis and
Sample Size Calculations