16SRDNA Sequencing of 30 Samples of Human Oral Microbial Samples by Tianjin Medical University

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.

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Key information

Conditions

Oral Microbiome Epidemiological Studies Sampling Methods

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical University School of Stomatology

Tianjin, Tianjin Municipality, 300070, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(1) People who had no oral diseases particularly caries, periodontitis, and oral mucosal diseases. (2) Teeth without previous restorations.

Exclusion criteria

(1) People who are pregnant. (2) People who suffer from severe systematic diseases, such as diabetes, immune system diseases, and genetic diseases. (3) People who have taken antibiotics within two weeks before sampling.(4) People who have had or currently receiving radiotherapy or chemotherapy. (5) People with complete or incomplete absence of dentition. (6) Individuals who smoke or have smoked within the past six months

Treatment and study plan

Primary outcomes

16SRDNA sequencing of 30 samples of human oral microbial samples by Tianjin Medical University

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.

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.

Sponsors and collaborators

Lead sponsor

Tianjin Medical University

Other

Registry information

Official study title

16SRDNA Sequencing of 30 Samples of Human Oral Microbial Samples by Tianjin Medical University: Analysis of the Microbial Community Diversity in Various Regions of the Healthy Oral Cavity

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2024
First posted: Jul 26, 2024
Registry last updated: Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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