Subgingival Microbiota Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Periodontitis Patients

March 27, 2023 updated by: Liu guojing, Peking University

Subgingival Microbiome Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Aggressive Periodontitis Patients

The investigators planed to observe the microbiome of an aggressive periodontitis patient, during mechanical treatment, surgery(if indicated) and implant placement. The investigators designed to observe the changes after mechanical treatment.Then, the investigators will compare the sub-mucosa microbiome of implant and the subgingival community. The investigators expected a different community after treatment, and there could be similarity between implant and nature teeth.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Yu xiaoqian
  • Phone Number: +8613681093434
  • Email: y_pk@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100081
        • Peking University Hospital of stomatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

aggressive periodontitis patients with defection of dentition or shall extracted hopeless teeth, and intended to implant treatment.

Description

Inclusion Criteria:

  1. Subjects were between 18-35 years old and diagnosed with generalized aggressive periodontitis (GAgP) according to the 1999 International Classification of Periodontal Diseases (Armitage 1999);
  2. At least 20 teeth in the first appointment and at least 3 teeth(other than first molars and central incisors)with a probing depth(PD) ≥ 6mm, clinical attachment level (CAL)≥5mm;
  3. The clinical diagnosis was confirmed by evidence of inter-proximal bone loss on full-mouth periapical radiographs;
  4. Family history of aggressive periodontitis.

Exclusion Criteria:

  1. Uncontrolled systemic conditions including diabetes and hypertension;
  2. Pregnant or lactating;
  3. Smoking;
  4. Received periodontal treatment within the previous 6 months or antibiotic medication during the previous 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)
Time Frame: Baseline, 6 weeks after mechanical treatment
the diversity of subgingival community before and after mechanical treatment
Baseline, 6 weeks after mechanical treatment
changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)
Time Frame: before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.
the diversity of submucosa community before and after implatation
before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.
changes of prevalence and abundance of OTUs
Time Frame: Baseline, 6 weeks after mechanical treatment
compute and compare the prevalence and abundance of OTUs
Baseline, 6 weeks after mechanical treatment
changes of prevalence and abundance of OTUs
Time Frame: before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.
compute and compare the prevalence and abundance of OTUs
before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
changes of bleeding index
Time Frame: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
bleeding index after probing
Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
changes of probing depth
Time Frame: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
probing depth of indicated sites
Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
clinical attachment loss
Time Frame: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
by probe, the distance between CEJ and gingival sulcus
Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yu xiaoqian, Peking University Hospital of stomatology
  • Principal Investigator: Liu guojing, Peking University Hospital of stomatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PKUSSIRB-201525102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

haven't decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aggressive Periodontitis, Generalized

Clinical Trials on mechanical treatment(mainly scaling and root planing), periodontal surgery(if indicated), implant placement.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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