NCT04511403

Brief Summary

to assess the oral mucosal alterations and their prevalence secondary to use cardiovascular drugs in a sample of Egyptian population with cardiovascular diseases .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
338

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 8, 2020

Last Update Submit

August 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Periodontal condition.(Miranda et al., 2012)

    through study completion, an average of 1 year

  • Salivary glands function

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital- Based Cross-Sectional Study

You may qualify if:

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

You may not qualify if:

  • Patients not physically able to participate in survey or clinical oral examination.
  • 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.
  • patients suffering from any medical diseases with aphthous ulcer and any other cause of xerostomia than cardiovascular diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24716628BACKGROUND
  • Jager 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.

    PMID: 29356914BACKGROUND
  • Habbab 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.

    PMID: 20604876BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Mohamed Mostafa Sleem, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 8, 2020

First Posted

August 13, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

August 13, 2020

Record last verified: 2020-08