Visfatin Levels Before and After Periodontal Treatment | NCT02615626

Studies
Visfatin Levels Before and After Periodontal Treatment

NCT02615626

Sponsor

Bulent Ecevit University

Status

Completed

Last Update Posted

Nov 26, 2015Estimated

Enrollment

45Actual

Phase

Not provided

Conditions

Periodontal Diseases

Interventions

Non-surgical Periodontal Treatment.

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

Nov 2015

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

May 2012

Primary Completion Date

Oct 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Nov 23, 2015

First Submission Date that Met QC Criteria

Nov 24, 2015

First Posted Date

Nov 26, 2015Estimated

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

Nov 24, 2015

Last Update Posted Date

Nov 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 purpose of this study was to evaluate visfatin levels in different stages of periodontal diseases and health, moreover the effect of non-surgical periodontal therapy on visfatin levels in Gingival Crevicular Fluid (GCF) and Serum.

Detailed Description

Total of 45 patients were divided into three groups based on their clinical and radiographical examination. Group 1 chronic periodontitis (n: 15), group 2 plaque induced gingivitis (n: 15) and group 3 Periodontal health (n: 15). GCF and serum samples were collected before treatment and 1, 3, 6 months after treatment and were assayed using enzyme linked immunosorbent assay kit.

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

45Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Group 1	Periodontal healthy	Procedure: Non-surgical Periodontal Treatment.
Group 2	Gingivitis, Non-surgical Periodontal Treatment	Procedure: Non-surgical Periodontal Treatment.
Group 3	Chronic Periodontitis, Non-surgical Periodontal Treatment	Procedure: Non-surgical Periodontal Treatment.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-surgical Periodontal Treatment.	Procedure	Non-surgical periodontal therapy is an anti-infective therapy which includes both mechanical and chemotherapeutic approaches to minimize or eliminate microbial biofilm, the primary etiology of gingivitis and periodontitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visfatin levels: Change after periodontal treatment both in serum and GCF		baseline, 1, 3 and 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Group 1 Inclusion Criteria:

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

Group 2 Inclusion Criteria:

No alveolar bone and attachment loss
Inflammation signs such as redness, edema and increased BOP levels,
GI≥2, PPD≤3mm, CAL≤3mm.
Systematically healthy patients

Group 3 Inclusion Criteria:

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

Exclusion Criteria for all groups:

Aggressive Periodontitis,
Oral pathologies,
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 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Total of 45 patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ÇİĞDEM COŞKUN TÜRER, Ph.D	BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY	Principal Investigator

Locations

Not provided

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