NCT02069574

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 24, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

February 19, 2014

Last Update Submit

February 20, 2014

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Expression level of MicroRNAs using Microarray

    Change from Baseline in expression level of MicroRNAs at 1,6,12 months

Secondary Outcomes (1)

  • Expression level of cytokines using multiple cytokine analysis

    Change from Baseline in expression level of cytokines at 1,6,12 months

Study Arms (3)

severe periodontitis group

EXPERIMENTAL

non-surgical periodontal therapy

Procedure: non-surgical periodontal therapy

Moderate periodontitis group

EXPERIMENTAL

non-surgical periodontal therapy

Procedure: non-surgical periodontal therapy

healthy control

NO INTERVENTION

No treatment

Interventions

non-surgical periodontal therapyPROCEDURE
Moderate periodontitis groupsevere periodontitis group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASAN Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Su-Hwan Kim, PhD.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Su-Hwan Kim, PhD.

CONTACT

82-2-3010-5797shkimperio@amc.seoul.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 24, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

February 24, 2014

Record last verified: 2014-02

Locations

KR(1)