Salivary Interleukin-32, Interleukin-10, Interleukin-6 and Tumor Necrosis Factor-alpha Levels in Children

October 20, 2021 updated by: Sultan KELES, Aydin Adnan Menderes University

Evaluation of Salivary Interleukin-32, Interleukin-10, Interleukin-6 and Tumor Necrosis Factor-alpha Levels in Children With Early Childhood Caries.

This study aimed to evaluate the levels of interleukin 10, interleukin 6, interleukin 32 and tumor necrosis factor-alpha (TNF-α) in saliva of children with early childhood caries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fifty six children ( 28 with early childhood caries and 28 without early childhood caries ; age range 3-6 years) will be recruited for the study. Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded and saliva samples will be collected. Interleukin-32, Interleukin-10, Interleukin-6 and TNF-α will be analyzed in saliva samples by ELISA.

Study Type

Observational

Enrollment (Actual)

58

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

  • Turkey
      • Aydın, 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

3 years to 5 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

28 children with early childhood caries and 28 children without caries will be collected.

Description

Inclusion Criteria:

  • Children with untreated early chilhood caries
  • Age between 3 and 6 years

Exclusion Criteria:

  • Having a systemic problem or mental retardation
  • Children with treated caries

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: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with early chilhood caries
Early chilhood caries group
Diagnostic test: ELISA
Enzim linked immunoabsorbant assay
Without early chilhood caries
Control group
Diagnostic test: ELISA
Enzim linked immunoabsorbant assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-32
Time Frame: Baseline
Interleukin- 32 level
Baseline
IL-10
Time Frame: Baseline
Interleukin- 10 level
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-6
Time Frame: Baseline
Interleukin- 6 level
Baseline
Tnf-Alpha
Time Frame: Baseline
Tnf-alpha level
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

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)

July 1, 2021

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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