Subgingival Microbiota Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Periodontitis Patients
Subgingival Microbiome Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Aggressive Periodontitis Patients
1 other identifier
observational
12
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2016
Longer than P75 for all trials
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
March 9, 2017
CompletedFirst Posted
Study publicly available on registry
March 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMarch 29, 2023
March 1, 2023
4.7 years
March 9, 2017
March 27, 2023
Conditions
Keywords
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
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
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.
PMID: 29266363DERIVED
Biospecimen
some bacteria DNA from subgingival. No need for human DNA.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yu xiaoqian
Peking University Hospital of Stomatology
- PRINCIPAL INVESTIGATOR
Liu guojing
Peking University Hospital of Stomatology
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