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Analysis of biomarker and microbiome profile and assessment of clinical effectiveness for diagnosis of Chronic Periodontitis

Status Approved

  • First Submitted Date

    2021/03/31

  • Registered Date

    2021/04/08

  • Last Updated Date

    2021/03/25

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0006071
    Unique Protocol ID CRI21002
    Public/Brief Title Analysis of biomarker and microbiome profile and assessment of clinical effectiveness for diagnosis of Chronic Periodontitis
    Scientific Title Analysis of biomarker and microbiome profile and assessment of clinical effectiveness for diagnosis of Chronic Periodontitis
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CRI21002
    Approval Date 2021-01-14
    Institutional Review Board Name SEOUL NATIONAL UNIVERSITY DENTAL HOSPITAL INSTITUTIONAL REVIEW BOARD
    Institutional Review Board Address 101, Daehak-ro, Jongno-gu, Seoul
    Institutional Review Board Telephone 02-2072-3057
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name KI-TAE KOO
    Title Professor
    Telephone +82-2-2072-0108
    Affiliation Seoul National University Dental Hospital
    Address 101 DAEHAKNO, JONGNO-GU, SEOUL
    Contact Person for Public Queries
    Name HYUN-YOUNG SONG
    Title Researcher
    Telephone +82-2-2072-3071
    Affiliation Seoul National University Dental Hospital
    Address 101 DAEHAKNO, JONGNO-GU, SEOUL
    Contact Person for Updating Information
    Name HYUN-YOUNG SONG
    Title Researcher
    Telephone +82-2-2072-3071
    Affiliation Seoul National University Dental Hospital
    Address 101 DAEHAKNO, JONGNO-GU, SEOUL

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2021-01-28 Actual
    Target Number of Participant 100
    Primary Completion Date 2022-01-13 , Anticipated
    Study Completion Date 2022-01-13 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Seoul National University Dental Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2021-01-28 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Trade, Industry & Energy
    Organization Type Government
    Project ID 20000580

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Seoul National University Dental Hospital
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    Saliva is collected via distilled water gargling. Saliva is collected after 3 months after the periodontal disease group is treated with scaling and root planing, and the values before and after treatment are compared. Analysis of salivary biomarkers and oral microbes is used to confirm their association with gingival inflammation and their viability as diagnosis of chronic periodontitis

  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-control
    Time Perspective Cross-sectional  
    Target Number of Participant 100
    Cohort/Group Number 5
    Cohort/
    Group 1

    Cohort/Group Label

    Healthy group

    Cohort/Group Description

    Saliva biomarker (mmp-8) expression in the group with no inflammation in the periodontal tissue, slight inflammation, and probing depth of less than 3 mm.
    Cohort/
    Group 2

    Cohort/Group Label

    Periodontal disease stage 1

    Cohort/Group Description

    Saliva biomarker (mmp-8) expression in the group with inflammation on periodontal tissue and probing depth of less than 4 mm.
    Cohort/
    Group 3

    Cohort/Group Label

    Periodontal disease stage 2

    Cohort/Group Description

    Saliva biomarker (mmp-8) expression in the group with inflammation on periodontal tissue and probing depth of less than 5 mm.
    Cohort/
    Group 4

    Cohort/Group Label

    Periodontal disease stage 3

    Cohort/Group Description

    Saliva biomarker (mmp-8) expression in the group with severe periodontitis of probing depth of more than 6mm and severe bone loss.
    Cohort/
    Group 5

    Cohort/Group Label

    Periodontal disease stage 4

    Cohort/Group Description

    Saliva biomarker (mmp-8) expression in the group with severe periodontitis of probing depth of more than 6mm and severe bone loss which led to loss of opposing tooth
    Biospecimen
    Collection & Archiving    		 
    : DNA Collect & Archive: Sample with DNA
    Biospecimen Description 
    whole saliva

  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description 
    Subject who visited Seoul National University Dental Hospital.
    Sampling Method 
    Non-probability sampling, Subjects with or without periodontal disease.
    Condition(s)/Problem(s) * (K00-K93)Diseases of the digestive system 
       (K05.39)Chronic periodontitis, unspecified 

    Periodontal disease
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~89Year

    Description

    Subjects between 19 and 89 years old adult male and female who has more than or equal to 20 teeth.
    Exclusion Criteria 
    ① Patients who received periodontal treatment within last 4 months.
② History of antibiotic use within last 3 months.
③ History of immunosuppressant or corticosteroids within last 3 months.
④ Patients who has less than 20 teeth.
⑤ Patients with uncontrolled diabetes or hypertension.
⑥ Patients with severe cardiovascular disease, respiratory disease, kidney disease, liver disease, GI tract disease, blood disorders or neuropsychiatric disorders.
⑦ Patients with hyperthyroidism or hypothyroidism.
⑧ Pregnant women.
⑨ Patients with autoimmune disease.
⑩ History or present with malignant cancer in jaw.
⑪ History or present with drug or alcohol abuse within last 1 year.
⑫ Patients with other inflammatory disease such as stomatitis, oral cancer in addition to periodontal disease.
⑬ In cases where the researcher determines that participation is inappropriate due to ethical or unwanted impact on the results.
    Healthy Volunteers Yes

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Bio-availability
    Primary Outcome(s) 1
    Outcome 
    Degree of expression of biomarkers
    Timepoint 
    Initial, 3 months after periodontal treatment.
    Secondary Outcome(s) 1
    Outcome 
    Amount of oral microorganisms
    Timepoint 
    Initial, 3 months after periodontal treatment.

  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No

  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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