An observational study in Oral Microbiome, Sampling Methods and Epidemiological Studies, sponsored by Tianjin Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by Tianjin Medical University · Observational
Study Objective:
To explore suitable sampling sites and methods for oral epidemiological surveys in large populations, we aim to compare the distribution of the oral core microbiome at different sites and using different sampling methods in a small sample of healthy individuals.
Main Question:
What is the distribution of the oral core microbiome at different sampling sites and using different sampling methods in orally healthy individuals?
Study Design:
Participants will be randomly selected from a population of orally healthy individuals. After explaining the study to the participants and obtaining informed consent, they will complete a consent form and be informed of the precautions. Samples will be collected using cotton swabs and curettes from the buccal surface of the lower right first molar and using cotton swabs from the left and right buccal mucosa. The samples will be placed in pre-numbered test tubes and sent to the laboratory for microbiome analysis.
Tianjin Medical University is the lead sponsor of 46 studies on the registry; 29 are open to participants now.
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According to WHO-related standards, we have selected adults who are orally healthy, free from systemic diseases, and non-smokers.
Exclusion Criteria:
16SRDNA sequencing of 30 samples of human oral microbial samples by Tianjin Medical University
Four sites were assessed: the buccal mucosa on both sides and the buccal surfaces of the left and right mandibular first molars. Two sampling methods, swab and curette, were used to collect bacterial communities from healthy individuals. Specifically, buccal mucosa samples (n=10) and tooth surface samples (n=20) were analyzed using 16S rDNA gene sequencing. Bacterial signals were detected through fluorescence in situ hybridization (FISH), targeting the bacterial 16S rDNA gene. Metastats analysis and Wilcoxon test were used.
Time frame: 2021.07 - 2021.12 Finalize research topic. 2021.12 - 2022.06 Complete bibliometric analysis. 2022.06 - 2022.12 Acquire data for analysis. 2022.12 - 2023.06 Obtain analysis results. 2023.06 - 2024.01 Complete and submit the thesis.
Plan to share: Undecided — Objective: Our goal is to facilitate the advancement of scientific research by sharing individual participant data (IPD) from our study on the microbial community diversity in various regions of the healthy oral cavity. This sharing plan is designed to ensure that data is accessible to researchers while protecting the privacy and confidentiality of study participants. Data to be Shared: The IPD to be shared includes: 1. Demographic Information: * Age * Gender 2. Microbial Data: * Microbiome sequencing data (raw and processed sequences) * Operational Taxonomic Units (OTUs) and species-level identification 3. Sampling and Processing Details: * Method of sample collection (swab vs. scraper)
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University