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

Completed

• Conditions: Aggressive Periodontitis, Generalized

• Registration Number: NCT03090282
• Lead Sponsor: Peking University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-24
• Primary Completion: 2020-12-01
• Study Completion: 2022-03-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes of prevalence and abundance of OTUs	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
changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)	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

Secondary Outcome Measures

Name	Time	Method
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.	bleeding index after probing
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.	by probe, the distance between CEJ and gingival sulcus
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.	probing depth of indicated sites

Trial Locations

Locations (1)

Peking university hospital of stomatology; 🇨🇳 Beijing, Beijing, China