NCT04655859

Brief Summary

The aim of this study was to evaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

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

Study Start

First participant enrolled

May 10, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
Last Updated

December 7, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 30, 2020

Last Update Submit

November 30, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • thiol/disulfide homeostasis

    Unstimulated saliva samples were taken from all children. Then, thiol/disulfide homeostasis and antioxidant levels were evaluated.

    six months

Study Arms (2)

severe early childhood caries

Diagnostic Test: saliva cotton swab

healthy children

Diagnostic Test: saliva cotton swab

Interventions

saliva cotton swabDIAGNOSTIC_TEST

evaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries and healthy group

healthy childrensevere early childhood caries

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

the children with severe early childhood caries which are 3-5 years

You may qualify if:

  • years

You may not qualify if:

  • the children with systemic illness, using anti-inflammatory drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aslı Soğukpınar

Kahramanmaraş, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 7, 2020

Study Start

May 10, 2020

Primary Completion

June 10, 2020

Study Completion

September 15, 2020

Last Updated

December 7, 2020

Record last verified: 2020-11

Locations