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

• Sponsor: Aydin Adnan Menderes University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04958005
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 19.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Early Childhood Caries	Diagnostic Test: ELISA

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 Design

• Study Type: Observational
• Actual Enrollment: 58 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Evaluation of Salivary Interleukin-32, Interleukin-10, Interleukin-6 and Tumor Necrosis Factor-alpha Levels in Children With Early Childhood Caries.
• Actual Study Start Date: Jul 1, 2021
• Actual Primary Completion Date: Aug 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. IL-32 [Baseline]

   Interleukin- 32 level

2. IL-10 [Baseline]

   Interleukin- 10 level

Secondary Outcome Measures

1. IL-6 [Baseline]

   Interleukin- 6 level

2. Tnf-Alpha [Baseline]

   Tnf-alpha level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 70 Months
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sultan KELEŞ	Aydın		Turkey	09100

Sponsors and Collaborators

• Aydin Adnan Menderes University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sultan KELES, Assoc.Prof.Dr., Aydin Adnan Menderes University
• ClinicalTrials.gov Identifier: NCT04958005
• Other Study ID Numbers: 2020/190
• First Posted: Jul 12, 2021
• Last Update Posted: Oct 21, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sultan KELES, Assoc.Prof.Dr., Aydin Adnan Menderes University: early childhood caries
• Additional relevant MeSH terms: Necrosis

Study Results

No Results Posted as of Oct 21, 2021