NCT03507868

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

April 16, 2018

Last Update Submit

April 16, 2018

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • YKL-40 levels

    changes in YKL-40 levels after periodontal therapy

    at first and third month after therapy

Secondary Outcomes (1)

  • IL-6 levels

    at first and third month after therapy

Study Arms (2)

Group 1

Periodontally healthy individuals

Group 2

Chronic periodontitis patients

Procedure: Nonsurgical periodontal therapy

Interventions

Nonsurgical periodontal therapyPROCEDURE

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.

Group 2

Eligibility Criteria

Age26 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

A total of 52 participants

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,
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva and gingival crevicular fluid

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ZEYNEP PINAR KELEŞ

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 25, 2018

Study Start

September 1, 2016

Primary Completion

April 1, 2017

Study Completion

January 1, 2018

Last Updated

April 25, 2018

Record last verified: 2018-04