Oxidative StressNCT04298996
Effect of Passive Smoking on Oxidative Stress and Dental Caries in Children
An observational study of Oxidative Stress and Dental Caries, run by Merve Erkmen Almaz.
Trial summary
The purpose of the present study was to determine the effect of passive smoking on oxidative stress and dental caries in children.A total of 180 children were included to the study as follows; 90 children exposed to passive smoking, and 90 children in the control group (unexposed controls). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Dental Caries, Passive Smoking
- What is being tested?
- taking saliva samples to determine oxidative stress markers TAS and TOS
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2016to 15 Aug 2018
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children, referring for dental examination to the Department of Pediatric Dentistry of Kirikkale University, were selected.
Who may be able to join
- -Systemically healthy children
Who cannot join
- Uncooperative children
- The presence of orthodontic/intraoral appliance
- Any disease or condition known to affect oxidative stress
About this study
The purpose of the present study was to determine the effect of passive smoking on oxidative stress and dental caries in children.A total of 180 children were included to the study as follows; 90 children exposed to passive smoking, and 90 children in the control group (unexposed controls). Also demographic data were recorded (age, gender, parental education levels, child's tooth-brushing habit and child's daily dietary sugar exposure, family income). Dental examination of children were performed and caries prevalence of the patients were recorded. Unstimulated saliva samples were collected from children. Saliva 'cotinine levels' and oxidative stress markers 'total antioxidant status' (TAS), and' total oxidant status' (TOS) were evaluated by using Enzyme-linked immunosorbent assay (ELISA). The obtained data parameters of the two groups were evaluated and comparison was performed.
- Conditions
- Oxidative Stress, Dental Caries, Passive Smoking
- Being tested
- taking saliva samples to determine oxidative stress markers TAS and TOS
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taking saliva samples to determine oxidative stress markers TAS and TOSDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| study group (passive smoking children) | examining for caries prevalence and taking saliva samples to determine oxidative stress markers TAS and TOS Receives: Diagnostic Test: taking saliva samples to determine oxidative stress markers TAS and TOS | |
| control group | examining for caries prevalence and taking saliva samples to determine oxidative stress markers TAS and TOS Receives: Diagnostic Test: taking saliva samples to determine oxidative stress markers TAS and TOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
determining oxidative stress marker in saliva: TAS
Unstimulated saliva samples were collected from children.
Measured: 1 day (once after the dental examination)]
determining oxidative stress marker in saliva: TOS
Unstimulated saliva samples were collected from children.
Measured: 1 day (once after the dental examination)
determining caries prevalence
Children were examined to determine caries prevalence.
Measured: 1 day (once for dental examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start16 Nov 2016
- Primary completion15 Apr 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merve Erkmen Almaz
- Sponsor type
- University, hospital or other
- Collaborators
- Kırıkkale University
- Responsible party
- Sponsor-investigator, Merve Erkmen Almaz, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298996
- Sponsor's protocol ID
- 2016-140
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Passive Smoking on Oxidative Stress and Dental Caries in Children
- ClinicalTrials.gov ID
- NCT04298996
- Acronym / sponsor ID
- 2016-140
- Conditions
- Oxidative Stress, Dental Caries, Passive Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Merve Erkmen AlmazUniversity, hospital or other
- Collaborators
- Kırıkkale University
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 6 Mar 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 purpose of the present study was to determine the effect of passive smoking on oxidative stress and dental caries in children.A total of 180 children were included to the study as follows; 90 children exposed to passive smoking, and 90 children in the control group (unexposed controls). Also demographic data were recorded (age, gender, parental education levels, child's tooth-brushing habit and child's daily dietary sugar exposure, family income). Dental examination of children were performed and caries prevalence of the patients were recorded. Unstimulated saliva samples were collected from children. Saliva 'cotinine levels' and oxidative stress markers 'total antioxidant status' (TAS), and' total oxidant status' (TOS) were evaluated by using Enzyme-linked immunosorbent assay (ELISA). The obtained data parameters of the two groups were evaluated and comparison was performed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group (passive smoking children) | – | Diagnostic Test: taking saliva samples to determine oxidative stress markers TAS and TOSexamining for caries prevalence and taking saliva samples to determine oxidative stress markers TAS and TOS |
| control group | – | Diagnostic Test: taking saliva samples to determine oxidative stress markers TAS and TOSexamining for caries prevalence and taking saliva samples to determine oxidative stress markers TAS and TOS |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children, referring for dental examination to the Department of Pediatric Dentistry of Kirikkale University, were selected.
Key inclusion criteria (1 listed)
- -Systemically healthy children
Key exclusion criteria (3 listed)
- Uncooperative children
- The presence of orthodontic/intraoral appliance
- Any disease or condition known to affect oxidative stress
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 |
|---|---|---|
| taking saliva samples to determine oxidative stress markers TAS and TOS | Diagnostic test | control group, study group (passive smoking children) |
Primary outcome
determining oxidative stress marker in saliva: TAS
Time frame: 1 day (once after the dental examination)]
Unstimulated saliva samples were collected from children.
determining oxidative stress marker in saliva: TOS
Time frame: 1 day (once after the dental examination)
Unstimulated saliva samples were collected from children.
determining caries prevalence
Time frame: 1 day (once for dental examination)
Children were examined to determine caries prevalence.
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 9 Mar 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Stress and Dental Caries, run by Merve Erkmen Almaz.
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 3 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 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
determining oxidative stress marker in saliva: TAS (time frame: 1 day (once after the dental examination)]). The study lists 3 primary outcomes in all. 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 9 Mar 2020.