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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04213482
Other study ID # 2018/209
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2018
Est. completion date December 20, 2019

Study information

Verified date December 2019
Source Nuh Naci Yazgan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluated pediatric oncology patients in terms of quality of bone and determine any relation between bone quality and radiotherapy/chemotherapy. The alternative hypothesis is that the bone quality of the oncology patients who received radiotherapy/chemotherapy is lower than the control group.


Description:

Cancer is the abnormal and uncontrolled proliferation of certain tissues in the body for a reason that cannot be determined yet. Childhood cancers occur between 0-17 years of age, and follow-up and treatment of these patients are performed in pediatric oncology services. Diagnosis in childhood cancers can be made by clinical examination as well as blood tests and examination of tissue samples. There are also some imaging methods used for diagnosis; ultrasonography, computed tomography, magnetic resonance imaging, positron emission tomography / computed tomography (PET / CT).

Treatment methods in childhood cancers are as follows; surgery, chemotherapy, radiotherapy and stem cell transplantation. Once diagnosed, oncologists and surgeons may choose one of these treatment options by mutual consultation or decide on a treatment method. Fractal analysis is a numerical as fractal dimension. Trabeculae are thin columns with numerous large spaces that give a honeycomb or spongy appearance of cancellous bone, which is also called trabecular bone or spongy bone. Previously, fractal analysis has been reported as a useful method to detect various diseases that affect the trabecular bone structure. Particularly in the field of dentistry, studies have shown that fractal analysis by the box-counting method can successfully evaluate trabecular changes in the mandible of patients with osteoporosis and periodontal diseases and in lactating women.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 20, 2019
Est. primary completion date August 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 23 Years
Eligibility Inclusion Criteria:

- to have been treated for any oncological diseases in childhood

- oncological treatment completed at least one year ago

Exclusion Criteria:

- ongoing oncological treatment

- patients who unwilling to participate to study

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Panoramic Radiography
Diagnostic Panoramic Dental Radiographs were taken.

Locations

Country Name City State
Turkey Nuh Naci Yazgan University Kayseri Kocasinan

Sponsors (1)

Lead Sponsor Collaborator
Nuh Naci Yazgan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bone Mineral Density (BMD) Fractal Dimension of the mandibular bone in patients with pediatric oncologic diseases will be measured on dental panoramic images to asses bone mineral density of mandibula. Image J software will be used to Fractal Analysis measurements. Participants to undergo a single assessment; to be measured at least 1 year after completion of oncologic therapy
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