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

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ClinicalTrials.gov Identifier: NCT03910205
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sultan KELES, 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.

Condition or disease Intervention/treatment
Periodontal Diseases Diagnostic Test: ELISA

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.

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Study Type : Observational
Estimated Enrollment : 88 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Gingival Crevicular Fluid Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
Type 1 diabetes with gingivitis
Children with type 1 diabetes mellitus and gingivitis
Diagnostic Test: ELISA
Enzim linked immunoabsorbant assay

Type 1 diabetes with healthy gingiva
Children with type 1 diabetes mellitus and healthy gingiva
Diagnostic Test: ELISA
Enzim linked immunoabsorbant assay

Healthy patients with gingivitis
Systemically healthy patients with gingivitis
Diagnostic Test: ELISA
Enzim linked immunoabsorbant assay

Healthy patients with healthy gingiva
Systemically healthy patients with healthy gingiva
Diagnostic Test: ELISA
Enzim linked immunoabsorbant assay




Primary Outcome Measures :
  1. Interleukin-18 level [ Time Frame: Baseline ]
    IL-18


Secondary Outcome Measures :
  1. Tnf-alpha level [ Time Frame: Baseline ]
    Tnf-Alpha


Biospecimen Retention:   Samples Without DNA
Gingival crevicular fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
88 Children with diabetes mellitus and systemically healty children with and without gingivitis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910205


Contacts
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Contact: Sultan KELES, Dr. 05318438557 dtsultank@gmail.com

Locations
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Turkey
Sultan KELES Recruiting
Aydin, Turkey, 09100
Contact: Sultan KELES    5318438557    dtsultank@gmail.com   
Sponsors and Collaborators
Adnan Menderes University
Investigators
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Principal Investigator: Sultan KELES, Dr. Dr.

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Responsible Party: Sultan KELES, Assist. Prof.Dr., Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03910205     History of Changes
Other Study ID Numbers: 2019-062
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sultan KELES, Adnan Menderes University:
interleukin-18
gingival crevicular fluid
tumor necrosis factor alpha

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Necrosis
Periodontal Diseases
Gingivitis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases