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

NCT06522841 | Completed

• 1 other identifier: TMUhMEC20221105
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Microbiome; Sampling Methods; Epidemiological Studies

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

According to WHO-related standards, we have selected adults who are orally healthy, free from systemic diseases, and non-smokers.

You may qualify if:

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

You may not qualify if:

• (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

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (1)

Tianjin Medical University School of Stomatology

Tianjin, Tianjin Municipality, 300070, China

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Endodontics and Laboratory for Dental Stem Cells and Endocrine Immunology, Tianjin Medical University School of Stomatology, Tianjin, China.

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2021
• Primary Completion: December 2, 2021
• Study Completion: June 1, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

CN (1)