Oral Complications in Hematological Malignancies

August 13, 2023 updated by: Merit Rafeek Gerges Botros, Assiut University

Prevalence and Types of Oral Complications Occuring in Hematological Malignancy Patients.:Cross Sectional Study

The aim of this study was to evaluate the prevalence and types of oral complications found in patients diagnosed with haematological malignancy

Study Overview

Status

Recruiting

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

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Assiut, Egypt
        • Recruiting
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All newly diagnosed patients elder than 18 years with hematological malignancy

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Nabila Fayek, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

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.

Clinical Trials on Hematologic Malignancy

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