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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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 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

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

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

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

Peking University

Investigators

  • 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)

April 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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