NCT02750956

Brief Summary

The primer aim of the study was to determine serum and gingival crevicular fluid (GCF) endocan levels in periodontal diseases pathogenesis supported with vascular endothelial growth factor (VEGF) and tumor necrosis factor alpha (TNF-α) levels.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

April 19, 2016

Last Update Submit

April 21, 2016

Conditions

Periodontal Disease

Keywords

endocan proteinVEGF ATNF-alphaafter treatment

Outcome Measures

Primary Outcomes (1)

  • Endocan levels

    Change after periodontal treatment

    6 weeks

Secondary Outcomes (2)

  • VEGF levels

    6 weeks

  • TNF-alpha levels

    6 weeks

Study Arms (3)

Group 1

Periodontal healthy individuals

Group 2

Patients with chronic periodontitis

Procedure: Non-surgical periodontal treatment

Group 3

the same patients in group 2 after they had been treated with scaling and root planing (SRP) were considered as Group 3.

Procedure: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatmentPROCEDURE

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

Group 2Group 3

Eligibility Criteria

Age25 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Total of 40 individuals

You may qualify if:

  • No bone and attachment loss,
  • GI=0, PPD≤3mm, CAL≤3mm
  • Systematically healthy patients
  • GI\>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.
  • Systematically healthy patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid and Serum

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • ÇİĞDEM COŞKUN TÜRER

    BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 26, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

April 26, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share