Prevalence of Oral Mucosal Alterations In a Sample of Egyptian Patients With Cardiovascular Diseases: A Hospital- Based Cross-Sectional Study

August 11, 2020 updated by: Mohamed Abd El Basset Mostafa Mohamed Sleem, Cairo University
to assess the oral mucosal alterations and their prevalence secondary to use cardiovascular drugs in a sample of Egyptian population with cardiovascular diseases .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
338

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital- Based Cross-Sectional Study

Description

Inclusion Criteria:

  • 1-Patients >18-years-old. 2-Patients diagnosed with cardiovascular diseases (Ivanuša, 2014). 3-patients taking cardiovascular drugs(Dr. Shantala Arunkumar, 2013).

Exclusion Criteria:

  • 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.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Periodontal condition.(Miranda et al., 2012)
Time Frame: through study completion, an average of 1 year
Clinical examination with GO-index(Normal- Mild ≤2 -Moderate 2-4 mm- sever≥4 mm)
through study completion, an average of 1 year
Salivary glands function
Time Frame: through study completion, an average of 1 year
Clinical oral dryness examination (Jager et al., 2018) in addition using Xerostomia questionnaire (Wiener et al., 2010)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Mucosal changes

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.

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