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

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

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

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Diagnostic test: ELISA

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

• Study Contact: Name: Sultan KELES, Assoc.Prof.; Phone Number: 05318438557; Email: dtsultank@gmail.com
• Study Contact Backup: Name: Ozge CEVIK, Assoc.Prof.; Phone Number: 05365573259; Email: ozge.cevik@adu.edu.tr

Study Locations

• Turkey
  • Aydın, Turkey
    • Sultan Keles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Type 1 diabetes with gingivitis; Children with type 1 diabetes mellitus and gingivitis	Diagnostic test: ELISA; Saliva sample collection; Other Names: Thiol/disulphide measurement; Total thiol, native thiol and disulphide level
Type 1 diabetes with healthy gingiva; Children with type 1 diabetes mellitus and healthy gingiva	Diagnostic test: ELISA; Saliva sample collection; Other Names: Thiol/disulphide measurement; Total thiol, native thiol and disulphide level
Healthy children with gingivitis; Systemically healthy children with gingivitis	Diagnostic test: ELISA; Saliva sample collection; Other Names: Thiol/disulphide measurement; Total thiol, native thiol and disulphide level
Healthy children and healthy gingiva; Systemically healthy children with healthy gingiva	Diagnostic test: ELISA; Saliva sample collection; Other Names: Thiol/disulphide measurement; Total thiol, native thiol and disulphide level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular endothelial growth factor level	Vascular endothelial growth factor level in saliva	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thiol/disulphide measurement	Total thiol, native thiol and disulphite level in saliva	Baseline

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Principal Investigator: Sultan KELES, Assoc.Prof., Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: type 1 diabetes mellitus
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: 2020/114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No