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

NCT04470635 | Completed

• 1 other identifier: 2020/114
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Diseases

Keywords

type 1 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Vascular endothelial growth factor level

  Vascular endothelial growth factor level in saliva

  Baseline

Secondary Outcomes (1)

• Thiol/disulphide measurement

  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 children with gingivitis

Systemically healthy children with gingivitis

Diagnostic Test: ELISA

Healthy children and healthy gingiva

Systemically healthy children with healthy gingiva

Diagnostic Test: ELISA

Interventions

ELISA DIAGNOSTIC_TEST

Saliva sample collection

Also known as: Thiol/disulphide measurement, Total thiol, native thiol and disulphide level

Healthy children and healthy gingiva; Healthy children with gingivitis; Type 1 diabetes with gingivitis; Type 1 diabetes with healthy gingiva

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Eigthy children will be recuited for the study . The children will be classified into four subgroups based on their periodontal status; 1\) systemically and periodontally healthy children, 2) systemically healthy children with gingivitis (G), 3) periodontally healthy children with T1DM, and 4) children with T1DM and gingivitis . The plaque index, gingival index and probing pocket depth will be recorded. The vascular endothelial growth factor in saliva will be determined by ELISA. Additionally total and native thiao and disulphide levels in saliva will be determined.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Sultan Keles

Aydin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sultan KELES, Assoc.Prof.

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 14, 2020
• Study Start: July 25, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 1, 2020
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)