NCT03910205

Brief Summary

This study aimed to evaluate the levels of interleukin 18 and tumor necrosis factor-alpha (TNF-α) in gingival crevicular fluid (GCF) of children with type 1 diabetes mellitus and gingivitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

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

April 8, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

November 29, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

April 9, 2019

Last Update Submit

November 27, 2019

Conditions

Periodontal Diseases

Keywords

interleukin-18gingival crevicular fluidtumor necrosis factor alpha

Outcome Measures

Primary Outcomes (1)

  • Interleukin-18 level

    IL-18

    Baseline

Secondary Outcomes (1)

  • Tnf-alpha level

    Baseline

Study Arms (4)

Type 1 diabetes with gingivitis

Children with type 1 diabetes mellitus and gingivitis

Diagnostic Test: ELISA

Type 1 diabetes with healthy gingiva

Children with type 1 diabetes mellitus and healthy gingiva

Diagnostic Test: ELISA

Healthy patients with gingivitis

Systemically healthy patients with gingivitis

Diagnostic Test: ELISA

Healthy patients with healthy gingiva

Systemically healthy patients with healthy gingiva

Diagnostic Test: ELISA

Interventions

ELISADIAGNOSTIC_TEST

Enzim linked immunoabsorbant assay

Healthy patients with gingivitisHealthy patients with healthy gingivaType 1 diabetes with gingivitisType 1 diabetes with healthy gingiva

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

88 Children with diabetes mellitus and systemically healty children with and without gingivitis.

You may qualify if:

  • Children diagnosed as type 1 diabetes mellitus
  • Age between 7 and 14 years

You may not qualify if:

  • Having another systemic problem except type 1 diabetes mellitus
  • Children carrying orthodontic appliances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan KELES

Aydin, 09100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Sultan KELES, Dr.

    Dr.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.Dr.

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 10, 2019

Study Start

April 8, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

November 29, 2019

Record last verified: 2019-07

Locations

TU(1)