- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03365570
Prevalence of Oral Manifestations of Iron Deficiency Anemia in a Sample of Egyptian Population
Prevalence of Oral Manifestations of Iron Deficiency Anemia in a Sample of Egyptian Population, Hospital-based Cross-sectional Study
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt, 12613
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of oral mucosal lesions
Time Frame: 15 minutes
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Presence of oral mucosal lesions will be assessed by clinical picture into dichotomous outcome (Yes/No) and percentage of each.
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15 minutes
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Collaborators and Investigators
Sponsor
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
Publications and helpful links
General Publications
- DeLoughery TG. Iron Deficiency Anemia. Med Clin North Am. 2017 Mar;101(2):319-332. doi: 10.1016/j.mcna.2016.09.004. Epub 2016 Dec 8.
- Rohani B. Oral manifestations and blood profile in patients with iron deficiency anemia. J Formos Med Assoc. 2015 Jan;114(1):97. doi: 10.1016/j.jfma.2014.07.004. Epub 2014 Aug 10. No abstract available.
- Wu YC, Wang YP, Chang JY, Cheng SJ, Chen HM, Sun A. Oral manifestations and blood profile in patients with iron deficiency anemia. J Formos Med Assoc. 2014 Feb;113(2):83-7. doi: 10.1016/j.jfma.2013.11.010. Epub 2013 Dec 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- oral lesions and anemia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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