Salivary Interleukin-32, Interleukin-10, Interleukin-6 an... | NCT04958005

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

NCT04958005

Sponsor

Aydin Adnan Menderes University

Status

Completed

Last Update Posted

Oct 21, 2021Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Early Childhood Caries

Interventions

ELISA

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Aug 30, 2021Actual

Completion Date

Sep 30, 2021Actual

First Submitted Date

Jul 1, 2021

First Submission Date that Met QC Criteria

Jul 1, 2021

First Posted Date

Jul 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2021

Last Update Posted Date

Oct 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children with early chilhood caries		Early chilhood caries group	Diagnostic Test: ELISA
Without early chilhood caries		Control group	Diagnostic Test: ELISA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ELISA	Diagnostic Test	Enzim linked immunoabsorbant assay	Children with early chilhood caries Without early chilhood caries

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

70 Months

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sultan KELEŞ		Aydin		09100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided