Diagnosis of Periodontal Disease Using Genetic Marker in Saliva

Chronic Periodontitis Clinical Trial

Official title:

Identification of Novel Periodontal Disease Biomarkers Using microRNA Expression in Saliva

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02069574
• Other study ID #: 2013-0940
• Status: Not yet recruiting
• Phase: N/A
• First received: February 19, 2014
• Last updated: February 20, 2014
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2014
• Source: Asan Medical Center
• Contact: Su-Hwan Kim, PhD.
• Phone: 82-2-3010-5797
• Email: shkimperio[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Periodontitis
• Gingival Diseases
• Periodontal Diseases
• Periodontitis

Intervention

Procedure:
• non-surgical periodontal therapy

Locations

Country	Name	City	State
Korea, Republic of	ASAN Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression level of MicroRNAs using Microarray		Change from Baseline in expression level of MicroRNAs at 1,6,12 months	No
Secondary	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	Change from Baseline in expression level of cytokines at 1,6,12 months	No