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

NCT ID: NCT03910205

Last Updated: 2019-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-08

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Periodontal Diseases

Keywords

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interleukin-18 gingival crevicular fluid tumor necrosis factor alpha

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 1 diabetes with gingivitis

Children with type 1 diabetes mellitus and gingivitis

ELISA

Intervention Type DIAGNOSTIC_TEST

Enzim linked immunoabsorbant assay

Type 1 diabetes with healthy gingiva

Children with type 1 diabetes mellitus and healthy gingiva

ELISA

Intervention Type DIAGNOSTIC_TEST

Enzim linked immunoabsorbant assay

Healthy patients with gingivitis

Systemically healthy patients with gingivitis

ELISA

Intervention Type DIAGNOSTIC_TEST

Enzim linked immunoabsorbant assay

Healthy patients with healthy gingiva

Systemically healthy patients with healthy gingiva

ELISA

Intervention Type DIAGNOSTIC_TEST

Enzim linked immunoabsorbant assay

Interventions

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ELISA

Enzim linked immunoabsorbant assay

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Sultan KELES

Assist. Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sultan KELES, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dr.

Locations

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Sultan KELES

Aydin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019-062

Identifier Type: -

Identifier Source: org_study_id