Cardiac DiseaseNCT04511403
Prevalence of Oral Mucosal Alterations In a Sample of Egyptian Patients With Cardiovascular Diseases: A Hospital- Based Cross-Sectional Study
An observational study of Cardiac Disease, run by Cairo University.
Trial summary
to assess the oral mucosal alterations and their prevalence secondary to use cardiovascular drugs in a sample of Egyptian population with cardiovascular diseases . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Disease
- How many people
- 338 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Oct 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital- Based Cross-Sectional Study
Who may be able to join
- 1-Patients >18-years-old. 2-Patients diagnosed with cardiovascular diseases (Ivanuša, 2014). 3-patients taking cardiovascular drugs(Dr. Shantala Arunkumar, 2013).
Who cannot join
- 1- Patients not physically able to participate in survey or clinical oral examination.
- 2- Patients under immunosuppressive drugs. 3-Patients with dementia or confusion, severe illness. 4- patients who refuse to participate in the study. 5-patients with hormonal diseases like diabetes mellitus and others. 6-patients with conditions cause xerostomia like Sjogren's syndrome and any medical diseases other than cardiovascular diseases.
- 7-patients suffering from any medical diseases with aphthous ulcer and any other cause of xerostomia than cardiovascular diseases.
Trial locations and contacts
No sites are listed yet.
About this study
to assess the oral mucosal alterations and their prevalence secondary to use cardiovascular drugs in a sample of Egyptian population with cardiovascular diseases .
Read the detailed description
Cardiovascular diseases (CVD) still a major cause of health loss for all regions of the world. Sociodemographic change over the past 25 years has been associated with the dramatic decrease in CVD in regions with very high sociodemographic index (SDI), but only a gradual decrease or no change in most regions (Roth et al., 2017).
Statistics from the World Health Organization indicates that cardiovascular diseases are the leading cause of death in Egypt, accounting for 46% of total deaths ( Royal Philips,2018).
The mouth serves as "a mirror of health or disease, as a sentinel or early warning system, as an accessible model for the study of other tissues and organs, and as a potential source of pathology affecting other systems and organs (Dr. Shantala Arunkumar, 2013).
The oral cavity is considered as a window to the body because oral manifestations accompany many systemic diseases. In many instances, oral involvement first appears than other symptoms or lesions at other locations. These oral manifestations must be properly recognized if the patient is to receive appropriate diagnosis and referral for treatment (Mehrotra et al., 2010b).
People with cardiovascular disease and who are at high cardiovascular risk (due to the presence of one or more risk factors such as hypertension, diabetes, hyperlipidaemia or already established disease) need early detection and management using counselling and medicines, as appropriate(World Health Organization, 2013).
A great many cardiovascular drugs have adverse reactions in the mouth in the form of xerostomia, lichenoid reactions, burning mouth sensation, loss of taste sensation, gingival hyperplasia and bleeding(Arunkumar, 2013).
Cardiovascular disease is the main cause of early death among people with diabetes. People with diabetes also suffer from hypertension, dyslipidaemia, and obesity, which contribute to increased incidence of cardiovascular disease (Malik and Dwivedi, 2015).
CVDs are a leading cause of death worldwide including the Middle East. This is caused in part by the dysregulation of adipose tissue cause increasing in production of pro-inflammatory adipokines and reduction in cardio-protective adipokines such as adiponectin (Abu-Farha, Behbehani and Elkum, 2014).
Low- and middle-income countries are disproportionally affected: over 80% of CVD deaths take place in low- and middle-income countries and occur almost equally in men and women. By 2030, almost 23.6 million people will die from CVDs, mainly from heart disease and stroke (WHO, 2015).
Medications used for management of hypertension cause oral alternation like Diuretics cause oral dryness, adrenergic inhibitors cause oral dryness and ulcerations, calcium antagonists cause overgrowth of gingiva while ACE inhibitors affect test sensation and lichenoid reactions of the oral mucosa (Mehrotra et al., 2010).
- Conditions
- Cardiac Disease
- Medical subject headings
- Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral mucosal manifestations as listed (Dr. Shantala Arunkumar, 2013)
Clinical examination according to WHO (World Health Organization, 2010) Oral mucosal manifestations as listed (Dr. Shantala Arunkumar, 2013) Clinical examination according to WHO (World Health Organization, 2010) Dichotomous outcome (Yes/No).
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Periodontal condition.(Miranda et al., 2012)
Clinical examination with GO-index(Normal- Mild ≤2 -Moderate 2-4 mm- sever≥4 mm)
Measured: through study completion, an average of 1 year
Salivary glands function
Clinical oral dryness examination (Jager et al., 2018) in addition using Xerostomia questionnaire (Wiener et al., 2010)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd El Basset Mostafa Mohamed Sleem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511403
- Sponsor's protocol ID
- Mucosal changes
- Status last verified
- Aug 2020
- First submitted
- 8 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abu-Farha M, Behbehani K, Elkum N. Comprehensive analysis of circulating adipokines and hsCRP association with cardiovascular disease risk factors and metabolic syndrome in Arabs. Cardiovasc Diabetol. 2014 Apr 9;13:76. doi: 10.1186/1475-2840-13-76.
PubMed 24716628Jager DHJ, Bots CP, Forouzanfar T, Brand HS. Clinical oral dryness score: evaluation of a new screening method for oral dryness. Odontology. 2018 Oct;106(4):439-444. doi: 10.1007/s10266-018-0339-4. Epub 2018 Jan 22.
PubMed 29356914Habbab KM, Moles DR, Porter SR. Potential oral manifestations of cardiovascular drugs. Oral Dis. 2010 Nov;16(8):769-73. doi: 10.1111/j.1601-0825.2010.01686.x.
PubMed 20604876
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Oral Mucosal Alterations In a Sample of Egyptian Patients With Cardiovascular Diseases: A Hospital- Based Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04511403
- Acronym / sponsor ID
- Mucosal changes
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 13 Aug 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.
to assess the oral mucosal alterations and their prevalence secondary to use cardiovascular drugs in a sample of Egyptian population with cardiovascular diseases .
Detailed description
Cardiovascular diseases (CVD) still a major cause of health loss for all regions of the world. Sociodemographic change over the past 25 years has been associated with the dramatic decrease in CVD in regions with very high sociodemographic index (SDI), but only a gradual decrease or no change in most regions (Roth et al., 2017).
Statistics from the World Health Organization indicates that cardiovascular diseases are the leading cause of death in Egypt, accounting for 46% of total deaths ( Royal Philips,2018).
The mouth serves as "a mirror of health or disease, as a sentinel or early warning system, as an accessible model for the study of other tissues and organs, and as a potential source of pathology affecting other systems and organs (Dr. Shantala Arunkumar, 2013).
The oral cavity is considered as a window to the body because oral manifestations accompany many systemic diseases. In many instances, oral involvement first appears than other symptoms or lesions at other locations. These oral manifestations must be properly recognized if the patient is to receive appropriate diagnosis and referral for treatment (Mehrotra et al., 2010b).
People with cardiovascular disease and who are at high cardiovascular risk (due to the presence of one or more risk factors such as hypertension, diabetes, hyperlipidaemia or already established disease) need early detection and management using counselling and medicines, as appropriate(World Health Organization, 2013).
A great many cardiovascular drugs have adverse reactions in the mouth in the form of xerostomia, lichenoid reactions, burning mouth sensation, loss of taste sensation, gingival hyperplasia and bleeding(Arunkumar, 2013).
Cardiovascular disease is the main cause of early death among people with diabetes. People with diabetes also suffer from hypertension, dyslipidaemia, and obesity, which contribute to increased incidence of cardiovascular disease (Malik and Dwivedi, 2015).
CVDs are a leading cause of death worldwide including the Middle East. This is caused in part by the dysregulation of adipose tissue cause increasing in production of pro-inflammatory adipokines and reduction in cardio-protective adipokines such as adiponectin (Abu-Farha, Behbehani and Elkum, 2014).
Low- and middle-income countries are disproportionally affected: over 80% of CVD deaths take place in low- and middle-income countries and occur almost equally in men and women. By 2030, almost 23.6 million people will die from CVDs, mainly from heart disease and stroke (WHO, 2015).
Medications used for management of hypertension cause oral alternation like Diuretics cause oral dryness, adrenergic inhibitors cause oral dryness and ulcerations, calcium antagonists cause overgrowth of gingiva while ACE inhibitors affect test sensation and lichenoid reactions of the oral mucosa (Mehrotra et al., 2010).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital- Based Cross-Sectional Study
Key inclusion criteria (1 listed)
- 1-Patients >18-years-old. 2-Patients diagnosed with cardiovascular diseases (Ivanuša, 2014). 3-patients taking cardiovascular drugs(Dr. Shantala Arunkumar, 2013).
Key exclusion criteria (3 listed)
- 1- Patients not physically able to participate in survey or clinical oral examination.
- 2- Patients under immunosuppressive drugs. 3-Patients with dementia or confusion, severe illness. 4- patients who refuse to participate in the study. 5-patients with hormonal diseases like diabetes mellitus and others. 6-patients with conditions cause xerostomia like Sjogren's syndrome and any medical diseases other than cardiovascular diseases.
- 7-patients suffering from any medical diseases with aphthous ulcer and any other cause of xerostomia than cardiovascular diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral mucosal manifestations as listed (Dr. Shantala Arunkumar, 2013)
Time frame: through study completion, an average of 1 year
Clinical examination according to WHO (World Health Organization, 2010) Oral mucosal manifestations as listed (Dr. Shantala Arunkumar, 2013) Clinical examination according to WHO (World Health Organization, 2010) Dichotomous outcome (Yes/No).
2 secondary outcomes
Periodontal condition.(Miranda et al., 2012)
Time frame: through study completion, an average of 1 year
Salivary glands function
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Background: PubMed 24716628Abu-Farha M, Behbehani K, Elkum N. Comprehensive analysis of circulating adipokines and hsCRP association with cardiovascular disease risk factors and metabolic syndrome in Arabs. Cardiovasc Diabetol. 2014 Apr 9;13:76. doi: 10.1186/1475-2840-13-76.
- Background: PubMed 29356914Jager DHJ, Bots CP, Forouzanfar T, Brand HS. Clinical oral dryness score: evaluation of a new screening method for oral dryness. Odontology. 2018 Oct;106(4):439-444. doi: 10.1007/s10266-018-0339-4. Epub 2018 Jan 22.
- Background: PubMed 20604876Habbab KM, Moles DR, Porter SR. Potential oral manifestations of cardiovascular drugs. Oral Dis. 2010 Nov;16(8):769-73. doi: 10.1111/j.1601-0825.2010.01686.x.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Cairo 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 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: status not confirmed, as of the sponsor's last update on 13 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mostafa Sleem, doctor (01067083315, mohammed.sleem@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral mucosal manifestations as listed (Dr. Shantala Arunkumar, 2013) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04511403, which also lists 3 linked publications.
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 13 Aug 2020.