Cardiac DiseaseNCT03457974
Saliva Profiles in Children With Congenital Heart Disease
A study testing saliva in people with Cardiac Disease and Dental Caries, run by Istanbul University.
Trial summary
The purpose of this study was to evaluate whether there are relationships between the salivary oxidative stress status of children with CHD directly dental caries including gender, age, salivary flow rate, salivary pH, salivary buffering capacity and drug intake such as angiotensin-converting enzyme (ACE) inhibitors. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease, Dental Caries
- What is being tested?
- saliva
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 1 Jan 2012
- Phase
- Interventional
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3-12 years
- Caridac problems
Who cannot join
- other ages
- syndromes
- other systemic diseases
About this study
The purpose of this study was to evaluate whether there are relationships between the salivary oxidative stress status of children with CHD directly dental caries including gender, age, salivary flow rate, salivary pH, salivary buffering capacity and drug intake such as angiotensin-converting enzyme (ACE) inhibitors. If such relationships exist, they might be employed to patient caries -prevention treatment.
Read the detailed description
Using heart failure medications may cause low salivary pH and buffering capacity.As improved oral health is a priority for cardiac patients, it is necessary that they attend dental clinics for regular follow up.
This cross sectional study was carried out with 42 CHD and 42 healthy children who applied to Istanbul University, Faculty of Dentistry, Department of Pedodontics. Gender, age, general health and medications, and caries scores (dfs/DMFS) were recorded. Unstimulated saliva was collected from the participants and were assessed for the salivary secretion rate, salivary buffering capacity, pH, protein levels, superoxide dismutase (SOD), ferric reducing antioxidant power (FRAP), the thiobarbituric acid reactive substances (TBARS), protein carbonyl, protein thiols, total sialic acid.
- Conditions
- Cardiac Disease, Dental Caries
- Being tested
- saliva
- Keywords
- saliva composition, antioxidant activity, caries risk factors, congenital cardiac disease
- Medical subject headings
- Heart Diseases, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salivaOther
salivary secretion rate, salivary buffering capacity, pH, protein levels, superoxide dismutase (SOD), ferric reducing antioxidant power (FRAP), the thiobarbituric acid reactive substances (TBARS), protein carbonyl, protein thiols, total sialic acid.
| Study group | Role | What they receive |
|---|---|---|
| congenital heart disease | Experimental | 42 patients Receives: Other: saliva |
| helathy children | Other | 42 children Receives: Other: saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary secretion rate
salivary secretion rate
Measured: 2 hour
salivary buffering capacity
salivary buffering capacity
Measured: 2 hour
pH
pH
Measured: 2 hour
Secondary outcomes (4)
protein levels of saliva
protein levels
Measured: 2 hour
superoxide dismutase (SOD)
superoxide dismutase (SOD)
Measured: 2 hour
ferric reducing antioxidant power (FRAP)
ferric reducing antioxidant power (FRAP)
Measured: 2 hour
the thiobarbituric acid reactive substances (TBARS)
the thiobarbituric acid reactive substances (TBARS)
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Jan 2011
- Primary completion1 Jan 2012
- Study completion1 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- cross sectional study was carried out with 42 CHD and 42 healthy children
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Figen Seymen, Merve Bayram, Ezel Uslu, Sule Batu, Yegane Güven
- Responsible party
- Principal investigator, Mine Koruyucu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457974
- Sponsor's protocol ID
- 2010/1109-378
- Status last verified
- Mar 2018
- First submitted
- 23 Feb 2018
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saliva Profiles in Children With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT03457974
- Acronym / sponsor ID
- 2010/1109-378
- Conditions
- Cardiac Disease, Dental Caries
- Keywords
- saliva composition, antioxidant activity, caries risk factors, congenital cardiac disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Figen Seymen, Merve Bayram, Ezel Uslu, Sule Batu, Yegane Güven
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Jan 2012 (actual)
- Study completion
- 1 Jan 2012 (actual)
- First posted
- 8 Mar 2018 (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 this study was to evaluate whether there are relationships between the salivary oxidative stress status of children with CHD directly dental caries including gender, age, salivary flow rate, salivary pH, salivary buffering capacity and drug intake such as angiotensin-converting enzyme (ACE) inhibitors. If such relationships exist, they might be employed to patient caries -prevention treatment.
Detailed description
Using heart failure medications may cause low salivary pH and buffering capacity.As improved oral health is a priority for cardiac patients, it is necessary that they attend dental clinics for regular follow up.
This cross sectional study was carried out with 42 CHD and 42 healthy children who applied to Istanbul University, Faculty of Dentistry, Department of Pedodontics. Gender, age, general health and medications, and caries scores (dfs/DMFS) were recorded. Unstimulated saliva was collected from the participants and were assessed for the salivary secretion rate, salivary buffering capacity, pH, protein levels, superoxide dismutase (SOD), ferric reducing antioxidant power (FRAP), the thiobarbituric acid reactive substances (TBARS), protein carbonyl, protein thiols, total sialic acid.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- cross sectional study was carried out with 42 CHD and 42 healthy children
| Arm | Type | Receives |
|---|---|---|
| congenital heart disease | Experimental | Other: saliva42 patients |
| helathy children | Other | Other: saliva42 children |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 3-12 years
- Caridac problems
Key exclusion criteria (3 listed)
- other ages
- syndromes
- other systemic diseases
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 |
|---|---|---|
| salivasalivary secretion rate, salivary buffering capacity, pH, protein levels, superoxide dismutase (SOD), ferric reducing antioxidant power (FRAP), the thiobarbituric acid reactive substances (TBARS), protein carbonyl, protein thiols, total sialic acid. | Other | congenital heart disease, helathy children |
Primary outcome
salivary secretion rate
Time frame: 2 hour
salivary secretion rate
salivary buffering capacity
Time frame: 2 hour
salivary buffering capacity
pH
Time frame: 2 hour
pH
4 secondary outcomes
protein levels of saliva
Time frame: 2 hour
superoxide dismutase (SOD)
Time frame: 2 hour
ferric reducing antioxidant power (FRAP)
Time frame: 2 hour
the thiobarbituric acid reactive substances (TBARS)
Time frame: 2 hour
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 8 Mar 2018.
- Individual participant dataSharing planned: No
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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?
A study testing saliva in people with Cardiac Disease and Dental Caries, run by Istanbul University.
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 2 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 8 Mar 2018. 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?
salivary secretion rate (time frame: 2 hour). 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 8 Mar 2018.