NCT03789565

Brief Summary

Periodontal disease refers to inflammatory disease of the periodontium caused by the host and/or pathogenic microorganisms. Anti-inflammatory and pro-inflammatory cytokines play a role in the periodontal inflammation process. The aim of this study was to evaluate the levels of hepcidin, interleukin (IL)-6, and IL-10 levels in gingival crevicular fluid (GCF) and in serum samples obtained from individuals with periodontal inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

March 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

December 27, 2018

Last Update Submit

October 2, 2019

Conditions

Keywords

periodontal diseaseshepcidinelisainterleukin 6interleukin 10

Outcome Measures

Primary Outcomes (1)

  • Hepcidin levels

    Change in inflammatory phases

    1 year

Secondary Outcomes (2)

  • IL-6 levels

    1 year

  • IL-10 levels

    1 year

Study Arms (3)

Group 1. Healthy individuals from periodontal perspective:

GI \< 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography.

Other: Biomarker test

Group 2. Individuals diagnosed with Gingivitis

GI \> 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography.

Other: Biomarker test

Group 3. Individuals diagnosed with CP

GI \> 1, PD ≥ 5 mm, CAL ≥ 3 mm, with apparent bone loss on radiography.

Other: Biomarker test

Interventions

Diagnostic biomarker study

Group 1. Healthy individuals from periodontal perspective:Group 2. Individuals diagnosed with GingivitisGroup 3. Individuals diagnosed with CP

Eligibility Criteria

Age32 Years - 52 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study included a total of 60 individuals between 32 and 52 years of age, with a total number of teeth \> 20, who underwent consultation for periodontal treatment

You may qualify if:

  • Systematically healthy patients. Patients who did not receive any medication or periodontal treatment within the previous 6 months

You may not qualify if:

  • Individuals who smoked and women who were pregnant and/or lactating were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çiğdem Coşkun Türer

Zonguldak, 67600, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid and Serum

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical associate professor, DDS, PhD

Study Record Dates

First Submitted

December 27, 2018

First Posted

December 28, 2018

Study Start

March 15, 2017

Primary Completion

January 20, 2018

Study Completion

February 15, 2018

Last Updated

October 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations