- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04655859
Thiol/Disulfide and Oxidative Stress
November 30, 2020 updated by: Aslı Sogukpınar, Kahramanmaras Sutcu Imam University
Evaluation of Saliva Thiol/Disulfide Homeostasis and Oxidative Stress in Children With Severe Early Childhood Caries by a Novel Method- Part 1
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kahramanmaraş, Turkey
- Aslı Soğukpınar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
the children with severe early childhood caries which are 3-5 years
Description
Inclusion Criteria:
- 3-5 years
Exclusion Criteria:
- the children with systemic illness, using anti-inflammatory drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
severe early childhood caries
|
evaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries and healthy group
|
|
healthy children
|
evaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries and healthy group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
thiol/disulfide homeostasis
Time Frame: six months
|
Unstimulated saliva samples were taken from all children.
Then, thiol/disulfide homeostasis and antioxidant levels were evaluated.
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2020
Primary Completion (Actual)
June 10, 2020
Study Completion (Actual)
September 15, 2020
Study Registration Dates
First Submitted
November 30, 2020
First Submitted That Met QC Criteria
November 30, 2020
First Posted (Actual)
December 7, 2020
Study Record Updates
Last Update Posted (Actual)
December 7, 2020
Last Update Submitted That Met QC Criteria
November 30, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2020/1-19M
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The thiol/disulfide homeostasis and antioxidant levels is to be shared in this study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.