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

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ClinicalTrials.gov Identifier: NCT03090282
Recruitment Status : Unknown
Verified March 2017 by Liu guojing, Peking University.
Recruitment status was:  Recruiting
First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Liu guojing, 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.

Condition or disease Intervention/treatment
Aggressive Periodontitis, Generalized Procedure: mechanical treatment(mainly scaling and root planing), periodontal surgery(if indicated), implant placement.

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Subgingival Microbiome Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Aggressive Periodontitis Patients
Actual Study Start Date : March 2, 2016
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : January 1, 2018

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


Primary Outcome Measures :
  1. changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community) [ Time Frame: Baseline, 6 weeks after mechanical treatment ]
    the diversity of subgingival community before and after mechanical treatment

  2. changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community) [ Time Frame: 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

  3. changes of prevalence and abundance of OTUs [ Time Frame: Baseline, 6 weeks after mechanical treatment ]
    compute and compare the prevalence and abundance of OTUs

  4. changes of prevalence and abundance of OTUs [ Time Frame: 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


Secondary Outcome Measures :
  1. changes of bleeding index [ Time Frame: 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

  2. changes of probing depth [ Time Frame: 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

  3. clinical attachment loss [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
some bacteria DNA from subgingival. No need for human DNA.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
aggressive periodontitis patients with defection of dentition or shall extracted hopeless teeth, and intended to implant treatment.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090282


Contacts
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Contact: Liu guojing +8613681346354 liuguojing1992@163.com
Contact: Yu xiaoqian +8613681093434 y_pk@163.com

Locations
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China, Beijing
Peking university hospital of stomatology Recruiting
Beijing, Beijing, China, 100081
Contact: Liu guojing    +8613681346354    liuguojing1992@163.com   
Contact: Yu xiaoqian    +8613681093434    y_pk@163.com   
Principal Investigator: Liu guojing         
Sponsors and Collaborators
Peking University
Investigators
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Study Chair: Yu xiaoqian Peking University Hospital of Stomatology
Principal Investigator: Liu guojing Peking University Hospital of Stomatology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liu guojing, Principal Investigator, Peking University
ClinicalTrials.gov Identifier: NCT03090282     History of Changes
Other Study ID Numbers: PKUSSIRB-201525102
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: haven't decided yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liu guojing, Peking University:
mechanical treatment
implant
Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms