Severe Early Childhood CariesNCT04655859
Thiol/Disulfide and Oxidative Stress
An observational study of Severe Early Childhood Caries, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Severe Early Childhood Caries
- What is being tested?
- saliva cotton swab
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2020to 15 Sep 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Child
Study population: the children with severe early childhood caries which are 3-5 years
Who may be able to join
- 3-5 years
Who cannot join
- the children with systemic illness, using anti-inflammatory drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Severe Early Childhood Caries
- Being tested
- saliva cotton swab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| severe early childhood caries | Not described Receives: Diagnostic Test: saliva cotton swab | |
| healthy children | Not described Receives: Diagnostic Test: saliva cotton swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
thiol/disulfide homeostasis
Unstimulated saliva samples were taken from all children. Then, thiol/disulfide homeostasis and antioxidant levels were evaluated.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start10 May 2020
- Primary completion10 Jun 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Early Childhood CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı Sogukpınar, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655859
- Sponsor's protocol ID
- 2020/1-19M
- Status last verified
- Nov 2020
- First submitted
- 30 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The thiol/disulfide homeostasis and antioxidant levels is to be shared in this study.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Saliva Thiol/Disulfide Homeostasis and Oxidative Stress in Children With Severe Early Childhood Caries by a Novel Method- Part 1
- ClinicalTrials.gov ID
- NCT04655859
- Acronym / sponsor ID
- 2020/1-19M
- Conditions
- Severe Early Childhood Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| severe early childhood caries | – | Diagnostic Test: saliva cotton swab |
| healthy children | – | Diagnostic Test: saliva cotton swab |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- the children with severe early childhood caries which are 3-5 years
Key inclusion criteria (1 listed)
- 3-5 years
Key exclusion criteria (1 listed)
- the children with systemic illness, using anti-inflammatory drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saliva cotton swabevaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries and healthy group | Diagnostic test | healthy children, severe early childhood caries |
Primary outcome
thiol/disulfide homeostasis
Time frame: six months
Unstimulated saliva samples were taken from all children. Then, thiol/disulfide homeostasis and antioxidant levels were evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: Undecided. The thiol/disulfide homeostasis and antioxidant levels is to be shared in this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Early Childhood Caries, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thiol/disulfide homeostasis (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.