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

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ClinicalTrials.gov Identifier: NCT03365570
Recruitment Status : Enrolling by invitation
First Posted : December 7, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Eman Mohamed Abdallah Alsheikh, Cairo University

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
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 Type : Observational
Estimated Enrollment : 400 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 : February 17, 2018
Estimated Primary Completion Date : August 17, 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron




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



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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria

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

Exclusion Criteria

  1. Patients suffering from any other systemic diseases known to influence oral and maxillofacial manifestations will be excluded.
  2. Patients suffering from any other systemic diseases known to cause IDA as secondary condition will be excluded.
  3. Patients on drug therapy that may have oral mucosal manifestations.
  4. 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.
  5. Inflammatory diseases, malignancy, or recent surgery were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365570


Locations
Egypt
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

Publications of Results:
Other Publications:
Responsible Party: Eman Mohamed Abdallah Alsheikh, BDS, Master student at oral medicine department, Cairo University
ClinicalTrials.gov Identifier: NCT03365570     History of Changes
Other Study ID Numbers: oral lesions and anemia
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Eman Mohamed Abdallah Alsheikh, Cairo University:
hemoglobin, iron, oral lesions, oral manifestations,cross-sectional study

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Oral Manifestations
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Mouth Diseases
Stomatognathic Diseases
Signs and Symptoms