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临床试验/NCT07047027
NCT07047027已完成不适用

Microbial Communities in Root Canal Infections of Patients With Diabetes.

Bulent Ecevit University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
1
主要终点
Microbial analysis

研究概览

简要总结

The objective of this study was to assess the influence of Diabetes Mellitus on the microbial flora involved in root canal infections through a comparative analysis with that of systemically healthy patients.

详细描述

A total of 39 participants aged 18 to 65 years were enrolled in the study, including 21 patients with Diabetes Mellitus and 18 systemically healthy individuals (controls). In the diabetic group, 12 teeth were diagnosed with persistent endodontic infections (SEI) and 9 with primary endodontic infections (PEI). In the healthy group, 12 teeth presented with SEI and 6 with PEI. Root canal samples were obtained using sterile paper points, transferred into Eppendorf tubes containing phosphate-buffered saline (PBS), and stored at -80 °C until analysis. The V3-V4 hypervariable regions of 16S rRNA from both sample types were amplified and sequenced using the Illumina MiSeq platform. Amplicon sequence variants (ASVs), generated via the DADA2 pipeline, were analyzed in the QIIME2 environment and taxonomically assigned using the SILVA database. Microbial richness and diversity were assessed using alpha diversity indices (Chao1, Shannon, Simpson, Faith's PD, Fisher alpha) and beta diversity metrics (Bray-Curtis, Jaccard, Unweighted UniFrac, and Weighted UniFrac). Alpha and beta diversity metrics were compared using the Kruskal-Wallis test and pairwise permutational multivariate analysis of variance (PERMANOVA), respectively, via the phyloseq package in R (version 4.1). Differentially abundant taxa were identified using Linear Discriminant Analysis Effect Size (LEfSe).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria for patient selection were as follows: patients in the diabetic group were required to have a diagnosis of type 2 Diabetes Mellitus with no other systemic diseases; patients in the control group had to be systemically healthy with no history of any systemic illness. All participants must not have used antibiotics within the past three months, must not be pregnant, and must have teeth with intact coronal restorations that prevent direct pulp exposure to the oral environment. Only asymptomatic teeth diagnosed with chronic apical periodontitis and a Periapical Index (PAI) score of 3 or higher were included -

排除标准

  • The exclusion criteria were: teeth with extensive coronal destruction that would prevent rubber dam isolation, presence of pain, swelling, or sinus tract, presence of root or crown fractures, and periodontal pockets deeper than 3 mm.

结局指标

主要结局

Microbial analysis

时间窗: 8 weeks

Root canal microbial flora

次要结局

未报告次要终点

研究者

发起方
Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevinç Aktemur Türker

Professor

Bulent Ecevit University

研究点 (1)

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