An observational study in Root Canal Infection, sponsored by Bulent Ecevit University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Bulent Ecevit University · Observational
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.
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).
Bulent Ecevit University is the lead sponsor of 47 studies on the registry; 2 are open to participants now.
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Patients who were attended to the faculty of dentistry
Inclusion Criteria: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 -
Exclusion Criteria: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.
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Microbial analysis
Root canal microbial flora
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2024 to primary completion in Feb 2025, 5 months.
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Bulent Ecevit University