NCT02615626

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2012

Status
completed

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

Study Start

First participant enrolled

May 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

1.4 years

First QC Date

November 23, 2015

Last Update Submit

November 24, 2015

Conditions

Periodontal Diseases

Keywords

VisfatinGCFserumNon-surgical Periodontal Treatment.

Outcome Measures

Primary Outcomes (1)

  • Visfatin levels: Change after periodontal treatment both in serum and GCF

    baseline, 1, 3 and 6 months

Study Arms (3)

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

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

Group 1Group 2Group 3

Eligibility Criteria

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

Total of 45 patients

You may qualify if:

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

    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

November 23, 2015

First Posted

November 26, 2015

Study Start

May 1, 2012

Primary Completion

October 1, 2013

Study Completion

January 1, 2014

Last Updated

November 26, 2015

Record last verified: 2015-11