- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05758207
Oral Complications in Hematological Malignancies
Prevalence and Types of Oral Complications Occuring in Hematological Malignancy Patients.:Cross Sectional Study
Study Overview
Status
Conditions
Detailed Description
Oral lesions can be the first presentation of hematological malignancy. Dentists occasionally are the first healthcare provider that detect oral signs related to a systemic condition and thus contribute to the early diagnosis of the disease 1. Oral health can impact the progression and the outcome of haematological malignancy patients', many patients may suffer from oral infections that might affect hospital stay, treatment cost and patient prognosis 2. The oral manifestations of patients with hematological malignancy can occur due to the disease itself or as a consequence of treatment 3.
Anemia (paleness of mucosa), coagulation disorder, oral petechiae or ecchymosis, spontaneous gingival bleeding and oral infection (Ulcers and overgrowth) may be an oral manifestation of a hematologic malignancy either at diagnosis or during follow up as well as in relapse 4. The treatment of hematologic malignancy includes chemotherapy, radiotherapy, and hematopoietic stem cell transplantation (HSCT). Malignant cells are the target of antineoplastic drugs, but the oral epithelium and other cells with high mitotic rates are usually affected by the treatment. Chemotherapy and the conditioning regimen for HSCT have many adverse effects on the oral tissues depending on the type and dosage of medications 4. Oral mucositis, a common side effect of chemotherapy, causes severe pain, which is only relieved by opioids. Mucositis may appear as a generalized erythema and evolve into painful pseudomembranous ulcers. Neutropenia and thrombocytopenia are also common adverse effects of treatment, leaving patients more susceptible to oral bleeding, infections, and ulcerations. Oral mucosa pigmentation can also occur as an adverse effect of treatment 5. Considering these factors and lack of existing information, a study was designed to investigate the prevalence of oral complications problems occurring in a population of hematological malignancy patients in Assiut University Hospital.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Merit Rafeek
- Phone Number: 01270240012
- Email: toot.rafeek@gmail.com
Study Contact Backup
- Name: Mai Mostafa
- Phone Number: 01223971678
- Email: Mai_heamatology@aun.edu.eg
Study Locations
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-
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Assiut, Egypt
- Recruiting
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All newly diagnosed patients elder than 18 years with hematological malignancy start from January 1st 2022 to January 1st 2023 including Acute myeloid leukemia Acute lymphoblastic leukemia Chronic myeloid leukemia Chronic lymphoblastic leukemia Non-Hodgkin lymphoma Hodgkin lymphoma Multiple myeloma
Exclusion Criteria:
- Patient younger than 18 years old Patients previously diagnosed Patients refused to participate in our study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Calculate the prevalence of oral complications.
Time Frame: Baseline
|
Calculate the prevalence of oral complications with special attention to infectious complications in hematological malignancy patients.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the morbidity related to oral complication in haematological malignancy patients.
Time Frame: Baseline
|
Study the morbidity related to oral complication in haematological malignancy patients.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nabila Fayek, Assiut University
Publications and helpful links
General Publications
- Emodi O, Ohayon C, Bilder A, Capucha T, Wolff A, Rachmiel A. Postextraction Mucormycosis in Immunocompromised-Patient Management and Review of Literature. J Oral Maxillofac Surg. 2021 Jul;79(7):1482-1491. doi: 10.1016/j.joms.2021.01.019. Epub 2021 Jan 25.
- Elad S, Zadik Y, Yarom N. Oral Complications of Nonsurgical Cancer Therapies. Atlas Oral Maxillofac Surg Clin North Am. 2017 Sep;25(2):133-147. doi: 10.1016/j.cxom.2017.04.006. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Hematology malignancies
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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