Diagnosis of Periodontal Disease Using Genetic Marker in Saliva

February 20, 2014 updated by: Su-Hwan Kim, Asan Medical Center

Identification of Novel Periodontal Disease Biomarkers Using microRNA Expression in Saliva

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: severe periodontitis group
non-surgical periodontal therapy
Procedure: non-surgical periodontal therapy
Experimental: Moderate periodontitis group
non-surgical periodontal therapy
Procedure: non-surgical periodontal therapy
No Intervention: healthy control
No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Expression level of MicroRNAs using Microarray
Time Frame: Change from Baseline in expression level of MicroRNAs at 1,6,12 months
Change from Baseline in expression level of MicroRNAs at 1,6,12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression level of cytokines using multiple cytokine analysis
Time Frame: Change from Baseline in expression level of cytokines at 1,6,12 months
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Su-Hwan Kim, PhD., Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-0940

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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