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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2021/03/31
    • Registered Date : 2021/04/08
    • Last Updated Date : 2021/03/25
Background Information
1.Background  
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
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
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  
Contact Details
3.Contact Details  
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 
Status
4. Status Status  
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
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Ministry of Trade, Industry & Energy 
- Organization Type Government  
- Project ID 20000580 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Seoul National University Dental Hospital 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
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  
Study Design 정보
8. Study Design  
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 
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 
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 
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 
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 
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 
Subject Eligibility Information
9. Subject  
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
Periodontal disease  
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.
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
Outcome Measure(s) Information
10. Outcome Measure(s)  
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. 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No