- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03910205
Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus
November 27, 2019 updated by: SULTAN KELES, Aydin Adnan Menderes University
Gingival Crevicular Fluid Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
88
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aydin, Turkey, 09100
- Sultan Keles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
88 Children with diabetes mellitus and systemically healty children with and without gingivitis.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Type 1 diabetes with gingivitis
Children with type 1 diabetes mellitus and gingivitis
|
Enzim linked immunoabsorbant assay
|
Type 1 diabetes with healthy gingiva
Children with type 1 diabetes mellitus and healthy gingiva
|
Enzim linked immunoabsorbant assay
|
Healthy patients with gingivitis
Systemically healthy patients with gingivitis
|
Enzim linked immunoabsorbant assay
|
Healthy patients with healthy gingiva
Systemically healthy patients with healthy gingiva
|
Enzim linked immunoabsorbant assay
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interleukin-18 level
Time Frame: Baseline
|
IL-18
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tnf-alpha level
Time Frame: Baseline
|
Tnf-Alpha
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sultan KELES, Dr., Dr.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 8, 2019
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
June 30, 2019
Study Registration Dates
First Submitted
April 9, 2019
First Submitted That Met QC Criteria
April 9, 2019
First Posted (Actual)
April 10, 2019
Study Record Updates
Last Update Posted (Actual)
November 29, 2019
Last Update Submitted That Met QC Criteria
November 27, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-062
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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