Diagnosis of Periodontal Disease Using Genetic Marker in Saliva
Primary Purpose
Chronic Periodontitis
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
non-surgical periodontal therapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
A. Severe Periodontal Disease
- Patients with chronic severe periodontitis
- Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients.
- subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing
A. Moderate Periodontal Disease
- Patients with chronic moderate periodontitis
- Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients.
- subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing
C. Healthy Control
- Healthy periodontal patients ( more than 20 permanent teeth are present , in all parts of deep periodontal pockets measuring 4mm or less, and height is 2mm or less clinical attachment person)
- subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing
Exclusion Criteria:
- Received periodontal treatment within the last six months
- recently taken antibiotics within 3 months if you need a prescription antibiotic prophylaxis
- taking the drug can affect periodontal status for a long period of time
- pregnant or breastfeeding
- In case of oral inflammatory mucosal disease (Lichen planus, etc.)
- A history of alcoholism or drug abuse if
- other special systemic disease (high blood pressure)
- ages under 18
Sites / Locations
- ASAN Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
severe periodontitis group
Moderate periodontitis group
healthy control
Arm Description
non-surgical periodontal therapy
non-surgical periodontal therapy
No treatment
Outcomes
Primary Outcome Measures
Expression level of MicroRNAs using Microarray
Secondary Outcome Measures
Expression level of cytokines using multiple cytokine analysis
Pro-inflammatory biomarker : interleukin(IL)-1a, IL-1b, IL-6, IL-8
Matrix metalloproteinase(MMP) : MMP-8, MMP-9
Anti-inflammatory biomarker: IL-10, inhibitor of MMP (TIMP)-1
Full Information
NCT ID
NCT02069574
First Posted
February 19, 2014
Last Updated
February 20, 2014
Sponsor
Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02069574
Brief Title
Diagnosis of Periodontal Disease Using Genetic Marker in Saliva
Official Title
Identification of Novel Periodontal Disease Biomarkers Using microRNA Expression in Saliva
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the present study is to identify the novel periodontal disease biomarkers using differentially expressed microRNA in the saliva. The severity of chronic periodontal diseases and the time of pre- and post-treatment are major classification criteria. The obtained data will secure the foundation for the development of a new non-invasive diagnostic methods for early diagnosis & prognosis prediction of periodontal disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
severe periodontitis group
Arm Type
Experimental
Arm Description
non-surgical periodontal therapy
Arm Title
Moderate periodontitis group
Arm Type
Experimental
Arm Description
non-surgical periodontal therapy
Arm Title
healthy control
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Procedure
Intervention Name(s)
non-surgical periodontal therapy
Primary Outcome Measure Information:
Title
Expression level of MicroRNAs using Microarray
Time Frame
Change from Baseline in expression level of MicroRNAs at 1,6,12 months
Secondary Outcome Measure Information:
Title
Expression level of cytokines using multiple cytokine analysis
Description
Pro-inflammatory biomarker : interleukin(IL)-1a, IL-1b, IL-6, IL-8
Matrix metalloproteinase(MMP) : MMP-8, MMP-9
Anti-inflammatory biomarker: IL-10, inhibitor of MMP (TIMP)-1
Time Frame
Change from Baseline in expression level of cytokines at 1,6,12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A. Severe Periodontal Disease
Patients with chronic severe periodontitis
Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients.
subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing
A. Moderate Periodontal Disease
Patients with chronic moderate periodontitis
Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients.
subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing
C. Healthy Control
Healthy periodontal patients ( more than 20 permanent teeth are present , in all parts of deep periodontal pockets measuring 4mm or less, and height is 2mm or less clinical attachment person)
subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing
Exclusion Criteria:
Received periodontal treatment within the last six months
recently taken antibiotics within 3 months if you need a prescription antibiotic prophylaxis
taking the drug can affect periodontal status for a long period of time
pregnant or breastfeeding
In case of oral inflammatory mucosal disease (Lichen planus, etc.)
A history of alcoholism or drug abuse if
other special systemic disease (high blood pressure)
ages under 18
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Su-Hwan Kim, PhD.
Phone
82-2-3010-5797
Email
shkimperio@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su-Hwan Kim, PhD.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASAN Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su-Hwan Kim, PhD
Phone
82-2-3010-5797
Email
shkimperio@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Su-Hwan Kim, PhD
12. IPD Sharing Statement
Learn more about this trial
Diagnosis of Periodontal Disease Using Genetic Marker in Saliva
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