NCT05325905

Brief Summary

The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

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

October 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

1.5 years

First QC Date

April 6, 2022

Last Update Submit

April 6, 2022

Conditions

Keywords

pathogenesisGingival crevicular fluidcytokine

Outcome Measures

Primary Outcomes (1)

  • Interleukin-36γ (IL-36γ) levels in GCF

    GCF samples were obtained from one interproximal site in each quadrant

    Baseline

Secondary Outcomes (6)

  • Probing depth (PD)

    Baseline

  • Clinical attachment level (CAL)

    Baseline

  • Bleeding on Probing (BoP)

    Baseline

  • IL-10 and IL-1β levels in GCF

    Baseline

  • Plaque Index (PI)

    Baseline

  • +1 more secondary outcomes

Study Arms (3)

Healthy

bleeding on probing (BoP) ≤ 10% of the sites, probing depth (PD) ≤ 3 mm and no indication of clinical attachment level (CAL) or radiographic bone loss

Diagnostic Test: Gingival crevicular fluid sampling

Gingivitis

gingival inflammation (BoP ≥ 10% of the sites, red-blue discoloration of the gingiva and edema) PD ≤ 4 mm and no clinical attachment or radiographic bone loss

Diagnostic Test: Gingival crevicular fluid sampling

Periodontitis

PD ≤ 5 mm, radiographic bone loss, and 3-4 mm CAL in at least 30% of the sites

Diagnostic Test: Gingival crevicular fluid sampling

Interventions

GCF sampling and clinical periodontal measurements were performed

GingivitisHealthyPeriodontitis

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were selected from among admitting to Dentistry Faculty of Selcuk University.

You may qualify if:

  • Systemically healthy
  • non-smokers,
  • presence of at least 20 teeth in the mouth

You may not qualify if:

  • receiving periodontal therapy in the last 6 months;
  • receiving antibiotics or anti-inflammatory drugs in the last 6 months;
  • currently pregnant or breastfeeding
  • using a removable partial denture and removable or fixed orthodontic appliances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Mehtikar Gürsel

    Bezmialem University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 13, 2022

Study Start

October 1, 2014

Primary Completion

April 1, 2016

Study Completion

January 1, 2017

Last Updated

April 13, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Results will be shared if requested