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NCT04470635 Clinical Trial

Thiol/Disulphide Homeostasis and Vascular Endothelial Growth Factor Levels in Diabetic Children

Periodontal Diseases Clinical Trial

Official title:
Thiol/Disulphide Homeostasis and Salivary Vascular Endothelial Growth Factor Levels in Type 1 Diabetic Patients With Gingivitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04470635
Other study ID # 2020/114
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 25, 2020
Est. completion date October 1, 2020

Study information
Verified date January 2024
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study to evaluate the vascular endothelial growth factor level and thiol/disulphide homeostasis in saliva of diabetic children with gingivitis.

Description:

Eighty children (44 with type 1 diabetes mellitus and 44 systemically healthy) will be recruited for the study. The children will be divided into four subgroups based on their periodontal and systemic condition: 1) systemically and periodontally healthy children, 2) systemically healthy children with gingivitis, 3) periodontally healthy children with T1DM, and 4) children with T1DM and gingivitis. The plaque index, gingival index, probing pocket depth, will recorded. The vascular endothelial growth factor level determined by ELISA. Native thiol, total thiol and disulphide levels will be measured in saliva.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date October 1, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers
Gender All
Age group 7 Years to 14 Years
Eligibility Inclusion Criteria: - Children diagnosed as type 1 diabetes mellitus - Age between 7-14 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
Saliva sample collection

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 Vascular endothelial growth factor level Vascular endothelial growth factor level in saliva Baseline
Secondary Thiol/disulphide measurement Total thiol, native thiol and disulphite level in saliva Baseline
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