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

Aggressive Periodontitis, Generalized Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090282
• Other study ID #: PKUSSIRB-201525102
• Status: Completed
• Start date: April 1, 2016
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Aggressive Periodontitis, Generalized
• Periodontitis

Intervention

Procedure:
• mechanical treatment(mainly scaling and root planing), periodontal surgery(if indicated), implant placement.
The investigators shall follow the regular procedure to these patients.

Locations

Country	Name	City	State
China	Peking university hospital of stomatology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	changes of prevalence and abundance of OTUs	compute and compare the prevalence and abundance of OTUs	Baseline, 6 weeks after mechanical treatment
Primary	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	changes of bleeding index	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.
Secondary	changes of probing depth	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.
Secondary	clinical attachment loss	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.