Clinical trial NCT03090282: Subgingival Microbiota Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Periodontitis Patients
Official title: Subgingival Microbiome Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Aggressive Periodontitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aggressive Periodontitis, Generalized
Keywords: mechanical treatment
implant
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: aggressive periodontitis patients with defection of dentition or shall extracted hopeless teeth, and intended to implant treatment.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)
timeFrame: Baseline, 6 weeks after mechanical treatment
measure: changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)
timeFrame: before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.
measure: changes of prevalence and abundance of OTUs
timeFrame: Baseline, 6 weeks after mechanical treatment
measure: changes of prevalence and abundance of OTUs
timeFrame: before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.
Secondary outcomes:
measure: changes of bleeding index
timeFrame: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
measure: changes of probing depth
timeFrame: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
measure: clinical attachment loss
timeFrame: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university hospital of stomatology
state: Beijing
Study officials:
affiliation: Peking University Hospital of Stomatology
name: Yu xiaoqian
role: STUDY_CHAIR
affiliation: Peking University Hospital of Stomatology
name: Liu guojing
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.