NCT03090282

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

4.7 years

First QC Date

March 9, 2017

Last Update Submit

March 27, 2023

Conditions

Keywords

mechanical treatmentimplant

Outcome Measures

Primary Outcomes (4)

  • changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)

    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)

    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

    compute and compare the prevalence and abundance of OTUs

    Baseline, 6 weeks after mechanical treatment

  • changes of prevalence and abundance of OTUs

    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 Outcomes (3)

  • changes of bleeding index

    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

    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

    Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.

Interventions

The investigators shall follow the regular procedure to these patients.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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);
  • 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;
  • The clinical diagnosis was confirmed by evidence of inter-proximal bone loss on full-mouth periapical radiographs;
  • Family history of aggressive periodontitis.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking university hospital of stomatology

Beijing, Beijing Municipality, 100081, China

Location

Related Publications (1)

  • Liu G, Luan Q, Chen F, Chen Z, Zhang Q, Yu X. Shift in the subgingival microbiome following scaling and root planing in generalized aggressive periodontitis. J Clin Periodontol. 2018 Apr;45(4):440-452. doi: 10.1111/jcpe.12862. Epub 2018 Mar 6.

Biospecimen

Retention: SAMPLES WITH DNA

some bacteria DNA from subgingival. No need for human DNA.

MeSH Terms

Conditions

Aggressive Periodontitis

Interventions

Root Planing

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Yu xiaoqian

    Peking University Hospital of Stomatology

    STUDY CHAIR
  • Liu guojing

    Peking University Hospital of Stomatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 24, 2017

Study Start

April 1, 2016

Primary Completion

December 1, 2020

Study Completion

March 1, 2022

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations