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CompletedNCT04958005Updated Oct 21, 2021

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

An observational study in Early Childhood Caries, sponsored by Aydin Adnan Menderes University. Completed at 1 site in Turkey. Open to participants aged 3 Years to 70 Months. Per ClinicalTrials.gov, last updated 2021-10-21.

Sponsored by Aydin Adnan Menderes University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
58
Ages
3 Years to 70 Months
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Early Childhood Caries

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Keywords

  • early childhood caries
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In context

Necrosis

477 studies on the registry are indexed under Necrosis; 54 are open to participants now.

This study's enrollment of 58 is below the median of 100 across 147 observational studies indexed under Necrosis.

Browse Necrosis studies →

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 70 Months
Sexes eligible
All
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
58 participants (actual)
Patient registry
No

Groups and cohorts

  • Children with early chilhood caries

    Early chilhood caries group

    Diagnostic Test: ELISA

  • Without early chilhood caries

    Control group

    Diagnostic Test: ELISA

Interventions

  • Diagnostic testELISA

    Enzim linked immunoabsorbant assay

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What researchers measure

Primary outcomes

  1. IL-32

    Interleukin- 32 level

    Time frame: Baseline

  2. IL-10

    Interleukin- 10 level

    Time frame: Baseline

Secondary outcomes

  1. IL-6

    Interleukin- 6 level

    Time frame: Baseline

  2. Tnf-Alpha

    Tnf-alpha level

    Time frame: Baseline

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Study locations

1 site
  • Sultan KELEŞ
    Aydın, 09100, Turkey
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04958005
Lead sponsor
Aydin Adnan Menderes University
Responsible party
Sultan KELES (Assoc.Prof.Dr., Aydin Adnan Menderes University) — Principal investigator
First posted
Jul 12, 2021
Start date
Jul 1, 2021
Primary completion
Aug 30, 2021
Completion
Sep 30, 2021
Last update
Oct 21, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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