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NCT03910205 Clinical Trial

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

Periodontal Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03910205
Other study ID # 2019-062
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 8, 2019
Est. completion date June 30, 2019

Study information
Verified date July 2019
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 14 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• ELISA
Enzim linked immunoabsorbant assay

Locations
Country Name City State
Turkey Sultan KELES Aydin

Sponsors (1)
Lead Sponsor Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Interleukin-18 level IL-18 Baseline
Secondary Tnf-alpha level Tnf-Alpha Baseline
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