Evaluating Radiomorphometric Indices and Fractal Dimension of the Pediatric Oncology Patients on Panoramic Images

December 25, 2019 updated by: Hatice Cansu Kış, Nuh Naci Yazgan University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

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 Locations

    • Kocasinan
      • Kayseri, Kocasinan, Turkey, 38170
        • Nuh Naci Yazgan 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

6 years to 23 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients received chemotherapy and radiotherapy for a Pediatric oncologic disease

Description

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 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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
oncology patients
For this study, panoramic images were taken from pediatric patients who received radiotherapy and/or chemotherapy because of any oncologic disease.
Diagnostic Panoramic Dental Radiographs were taken.
healthy
panoramic images of patients(pediatric) who have no systemic disease were collected from the archive of dental radiology clinic of the university hospital.
Diagnostic Panoramic Dental Radiographs were taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density (BMD)
Time Frame: Participants to undergo a single assessment; to be measured at least 1 year after completion of oncologic therapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this 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, 2018

Primary Completion (Actual)

August 20, 2018

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

December 23, 2019

First Submitted That Met QC Criteria

December 25, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

December 30, 2019

Last Update Submitted That Met QC Criteria

December 25, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

all types of data can be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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