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

Completed

• Conditions: Periodontal Diseases
• Interventions: Diagnostic Test: ELISA

• Registration Number: NCT03910205
• Lead Sponsor: Aydin Adnan Menderes University

Brief 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.

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 Timeline

• Study Start: 2019-04-08
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-10
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-11-27
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy patients with healthy gingiva	ELISA	Systemically healthy patients with healthy gingiva
Healthy patients with gingivitis	ELISA	Systemically healthy patients with gingivitis
Type 1 diabetes with healthy gingiva	ELISA	Children with type 1 diabetes mellitus and healthy gingiva
Type 1 diabetes with gingivitis	ELISA	Children with type 1 diabetes mellitus and gingivitis

Primary Outcome Measures

Name	Time	Method
Interleukin-18 level	Baseline	IL-18

Secondary Outcome Measures

Name	Time	Method
Tnf-alpha level	Baseline	Tnf-Alpha

Trial Locations

Locations (1)

Sultan KELES; 🇹🇷 Aydin, Turkey