YKL-40 and IL-6 Levels in Periodontal Disease | NCT03507868

Studies
YKL-40 and IL-6 Levels in Periodontal Disease

NCT03507868

Sponsor

Zeynep Pinar KELES

Status

Completed

Last Update Posted

Apr 25, 2018Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Periodontal Diseases

Interventions

Nonsurgical periodontal therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Apr 2017Actual

Completion Date

Jan 2018Actual

First Submitted Date

Apr 16, 2018

First Submission Date that Met QC Criteria

Apr 16, 2018

First Posted Date

Apr 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2018

Last Update Posted Date

Apr 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primer aim of the study was to investigate saliva and gingival crevicular fluid (GCF) YKL-40 and also interleukin-6 (IL-6) levels in chronic periodontitis pathogenesis.

Detailed Description

This study consisted of two groups: 26 periodontally healthy individuals and 26 generalized chronic periodontitis patients. Chronic periodontitis patients were received nonsurgical periodontal treatment. Clinical measurements were recorded, saliva and GCF samples were obtained before and at first and third months after periodontal therapy. Levels of YKL-40 and IL-6 in saliva and GCF were analyzed by enzyme-linked immunosorbent assay.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Periodontally healthy individuals
Group 2		Chronic periodontitis patients	Procedure: Nonsurgical periodontal therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nonsurgical periodontal therapy	Procedure	Nonsurgical periodontal therapy includes oral hygiene education and scaling and root planning approaches to eliminate microbial dental plaque that is the primary etiology of periodontal diseases.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
YKL-40 levels	changes in YKL-40 levels after periodontal therapy	at first and third month after therapy

Secondary Outcomes

Measure	Description	Time Frame
IL-6 levels	changes in IL-6 levels after periodontal therapy	at first and third month after therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Group 1 Inclusion Criteria:

No bone and attachment loss,
GI=0, PPD≤3mm, CAL≤3mm
Systematically healthy patients

Group 2 Inclusion Criteria:

GI>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.
Systematically healthy patients

Exclusion Criteria:

Aggressive Periodontitis,
Patients with any other systemic diseases,
Pregnant women and those in the lactation period,
Patients with smoking habit and taking medication
Patients received periodontal therapy in last 6 month

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

26 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

A total of 52 participants

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided