Prevalence of Oral Manifestations of Iron Deficiency Anemia in a Sample of Egyptian Population

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03365570

Collaborator

(none)

180

Enrollment

Location

6.3

Actual Duration (Months)

28.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

According to WHO Reportin 2002, iron deficiency anemia was considered to be the most important contributing factor to the global burden of anemia. Children and women in reproductive ages are more at risk factor for developing iron deficiency anemia.No previous study has been held to assess prevalence of oral manifestations of iron deficiency anemia as a hospital-based cross-sectional study on a sample of Egyptian patients in hematology department (no previous data recorded).

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia

Detailed Description

Study will be held in at the Hematology department at El Qasr Al-Einy Cairo University Hospital data collection started from February 2018 till end of April 2018 primary completion.

Clinical examination performed for oral mucosa, the number and type of lesions will be recorded. Patients' age, sex, duration of illness, type of anemia, location of any oral lesion or abnormality, history of drug and alcohol consumption, and presence or absence of dentures, will be recorded participants will not followed up and data will be collected prospectively.

A copy of participant's blood record will be obtained from the hematology department upon its approval.

Participants:

Egyptian patients diagnosed with Iron deficiency anemia that attending the Hematology department at El Qasr Al-Einy Cairo University Hospital will be enrolled in the study. The age of participant enroll will be up to 70 years old, males and females will be included.

For each eligible participant, a full history will be obtained according to an assessment sheet, followed by clinical examination which will be done through an interview between the investigator and the patient.

All participants will be asked to sign a study-related informed consent. Oral manifestations of these patients will be evaluated by an oral medicine master student (the investigator).

Study Design

Study Type:

Observational

Actual Enrollment :

180 participants

Observational Model:

Ecologic or Community

Time Perspective:

Cross-Sectional

Official Title:

Prevalence of Oral Manifestations of Iron Deficiency Anemia in a Sample of Egyptian Population, Hospital-based Cross-sectional Study

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

Nov 1, 2018

Actual Study Completion Date :

Nov 9, 2018

Outcome Measures

Primary Outcome Measures

Prevalence of oral mucosal lesions [15 minutes]
Presence of oral mucosal lesions will be assessed by clinical picture into dichotomous outcome (Yes/No) and percentage of each.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

Patients diagnosed with iron deficiency anemia based on their blood tests.
Age: by maximum 70 years old.
Males and females will be included.

Exclusion Criteria

Patients suffering from any other systemic diseases known to influence oral and maxillofacial manifestations will be excluded.
Patients suffering from any other systemic diseases known to cause IDA as secondary condition will be excluded.
Patients on drug therapy that may have oral mucosal manifestations.
Lesions appear because of existing local factors for example traumatic ulcer on the tongue because of sharp tooth against tongue, angular cheilitis because of poor denture design and older age patients.
Inflammatory diseases, malignancy, or recent surgery were excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt	12613

Sponsors and Collaborators

Cairo University

Investigators

Study Chair: Fatheya Zahran, Professor, Head of the Department of Oral Medicine and periodontology Cairo University
Principal Investigator: Eman Alsheikh, Master student
Study Director: Eman Mo Amr, A.Professor, associate professor in the Department of Oral Medicine and periodontology Cairo University