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
CRIS Registration Number |
KCT0006071 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Trade, Industry & Energy |
Organization Type | Government |
Project ID | 20000580 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Seoul National University Dental Hospital |
Organization Type | Medical Institute |
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 |
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8. Study Design
Study Type | Observational Study |
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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
Study Population Description | Subject who visited Seoul National University Dental Hospital. |
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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)
Type of Primary Outcome | Bio-availability | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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