Clinical Trial on Cardiac Disease - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Cardiac Disease

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

Observational

Enrollment (Anticipated)

338

Contacts and Locations

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

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

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

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

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

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)

September 1, 2020

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

August 8, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 13, 2020

Study Record Updates

Last Update Posted (Actual)