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CompletedNCT03910205Updated Nov 29, 2019

Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus

An observational study in Periodontal Diseases, sponsored by Aydin Adnan Menderes University. Completed at 1 site in Turkey. Open to participants aged 7 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-29.

Sponsored by Aydin Adnan Menderes University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
88
Ages
7 Years to 14 Years
Sex
All
01

Study 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.

Read the detailed description

Eighty eight children (44 with type 1 diabetes mellitus and 44 healty; age range 7-14 years) will be recruited for the study. The children will be classified into four subgroups based on their periodontal status; 1) Children with gingivitis and diabetes mellitus (MG, n=22); 2) Children with type 1 diabetes mellitus with healthy periodontium (MH, n=22); 3)Healthy children with gingivitis (HG, n=22); 4) Healthy children with healthy periodontium (HH, n=22). Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded. Interleukin-18 and TNF-α will be analyzed in GCF and saliva samples by ELISA.

02

Conditions studied

  • Periodontal Diseases

Keywords

  • interleukin-18
  • gingival crevicular fluid
  • tumor necrosis factor alpha
03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 88 is close to the median of 90 across 104 observational studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Having another systemic problem except type 1 diabetes mellitus
  • Children carrying orthodontic appliances
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
88 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testELISA

    Enzim linked immunoabsorbant assay

06

What researchers measure

Primary outcomes

  1. Interleukin-18 level

    IL-18

    Time frame: Baseline

Secondary outcomes

  1. Tnf-alpha level

    Tnf-Alpha

    Time frame: Baseline

07

Study locations

1 site
  • Sultan KELES
    Aydin, 09100, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03910205
Lead sponsor
Aydin Adnan Menderes University
Responsible party
Sultan KELES (Assist. Prof.Dr., Aydin Adnan Menderes University) — Principal investigator
First posted
Apr 10, 2019
Start date
Apr 8, 2019
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
Nov 29, 2019

Study contacts

Sultan KELES, Dr.
principal investigator · Dr.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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