NCT04958005

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

July 1, 2021

Last Update Submit

October 20, 2021

Conditions

Early Childhood Caries

Keywords

early childhood caries

Outcome Measures

Primary Outcomes (2)

  • IL-32

    Interleukin- 32 level

    Baseline

  • IL-10

    Interleukin- 10 level

    Baseline

Secondary Outcomes (2)

  • IL-6

    Baseline

  • Tnf-Alpha

    Baseline

Study Arms (2)

Children with early chilhood caries

Early chilhood caries group

Diagnostic Test: ELISA

Without early chilhood caries

Control group

Diagnostic Test: ELISA

Interventions

ELISADIAGNOSTIC_TEST

Enzim linked immunoabsorbant assay

Children with early chilhood cariesWithout early chilhood caries

Eligibility Criteria

Age3 Years - 70 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan KELEŞ

Aydin, 09100, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.Dr.

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 12, 2021

Study Start

July 1, 2021

Primary Completion

August 30, 2021

Study Completion

September 30, 2021

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations

TU(1)