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  • Status : Approved
    • First Submitted Date : 2021/03/31
    • Registered Date : 2021/04/08
    • Last Updated Date : 2021/03/25
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1. Background

Background Information
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  
Address 101, Daehak-ro, Jongno-gu, Seoul 
Telephone 02-2072-3057 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
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 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 Site Seoul National University Dental Hospital 
Recruitment Status Recruiting  
Date of First Enrollment 2021-01-28 , Actual

5. Source of Monetary / Material Support

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

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
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 
Observational Study Model Case-control 
Time Perspective Cross-sectional    
Target Number of Participant 100
Cohort/Group Number
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. 
Biospecimen
Collection & Archiving
: DNA Collect & Archive: Sample with DNA 
Biospecimen Description whole saliva 
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. 
Biospecimen
Collection & Archiving
: DNA Collect & Archive: Sample with DNA 
Biospecimen Description whole saliva 
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. 
Biospecimen
Collection & Archiving
: DNA Collect & Archive: Sample with DNA 
Biospecimen Description whole saliva 
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. 
Biospecimen
Collection & Archiving
: DNA Collect & Archive: Sample with DNA 
Biospecimen Description whole saliva 
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) * Symptoms, signs and abnormal clinical and laboratory findings, NEC
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 89 Year
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. <br />② History of antibiotic use within last 3 months. <br />③ History of immunosuppressant or corticosteroids within last 3 months. <br />④ Patients who has less than 20 teeth. <br />⑤ Patients with uncontrolled diabetes or hypertension. <br />⑥ Patients with severe cardiovascular disease, respiratory disease, kidney disease, liver disease, GI tract disease, blood disorders or neuropsychiatric disorders. <br />⑦ Patients with hyperthyroidism or hypothyroidism. <br />⑧ Pregnant women. <br />⑨ Patients with autoimmune disease. <br />⑩ History or present with malignant cancer in jaw. <br />⑪ History or present with drug or alcohol abuse within last 1 year. <br />⑫ Patients with other inflammatory disease such as stomatitis, oral cancer in addition to periodontal disease. <br />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 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 No

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

Sharing of Study Data Information
Sharing Statement No 
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