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

November 27, 2019 updated by: SULTAN KELES, Aydin Adnan Menderes University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Aydin, Turkey, 09100
        • Sultan Keles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 1 diabetes with gingivitis
Children with type 1 diabetes mellitus and gingivitis
Diagnostic test: ELISA
Enzim linked immunoabsorbant assay
Type 1 diabetes with healthy gingiva
Children with type 1 diabetes mellitus and healthy gingiva
Diagnostic test: ELISA
Enzim linked immunoabsorbant assay
Healthy patients with gingivitis
Systemically healthy patients with gingivitis
Diagnostic test: ELISA
Enzim linked immunoabsorbant assay
Healthy patients with healthy gingiva
Systemically healthy patients with healthy gingiva
Diagnostic test: ELISA
Enzim linked immunoabsorbant assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin-18 level
Time Frame: Baseline
IL-18
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tnf-alpha level
Time Frame: Baseline
Tnf-Alpha
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Investigators

  • Principal Investigator: Sultan KELES, Dr., Dr.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2019

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 27, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-062

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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