Oral MicrobiomeNCT06522841
16SRDNA Sequencing of 30 Samples of Human Oral Microbial Samples by Tianjin Medical University
An observational study of Oral Microbiome and Sampling Methods, run by Tianjin Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Microbiome, Sampling Methods, Epidemiological Studies
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: According to WHO-related standards, we have selected adults who are orally healthy, free from systemic diseases, and non-smokers.
Who may be able to join
- (1) People who had no oral diseases particularly caries, periodontitis, and oral mucosal diseases. (2) Teeth without previous restorations.
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University School of Stomatology
Tianjin, Tianjin Municipality, 300070
About this study
Official 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
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.
Read more
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Sep 2021
- Primary completion2 Dec 2021
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuchang Liu, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522841
- Sponsor's protocol ID
- TMUhMEC20221105
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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)
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06522841
- Acronym / sponsor ID
- TMUhMEC20221105
- Conditions
- Oral Microbiome, Sampling Methods, Epidemiological Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- According to WHO-related standards, we have selected adults who are orally healthy, free from systemic diseases, and non-smokers.
Key inclusion criteria (1 listed)
- (1) People who had no oral diseases particularly caries, periodontitis, and oral mucosal diseases. (2) Teeth without previous restorations.
Key exclusion criteria (1 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Microbiome and Sampling Methods, run by Tianjin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.