Long Term Dental Effects in Adolescents Who Were Treated for Cancer in Childhood

January 18, 2023 updated by: Hadassah Medical Organization

Long Term Oral and Dental Effects in Adolescents Who Were Treated for Cancer in Childhood

The investigators aim is to explore associations between specific types of cancer therapy, age at treatment and the presence of dental abnormalities in adolescence.

The study will help identify unique dental changes, malformations and or missing teeth that appear in adolescence as a secondary complication due to anticancer treatment (chemotherapy and or radiotherapy) given in childhood.

Materials and methods:

  • Study Group: 200 patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old.
  • The following data will be collected: Demographic information, Medical Status, Cancer therapy, Intraoral examination, Oral soft and hard tissue condition and radiographic examination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

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

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization

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

12 years to 32 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old. The maximum time span of entering the study group-up to 20 years after last session of oncology treatment.

Description

Inclusion Criteria:

  • were treated for Cancer at the age of 0-10 years old

Exclusion Criteria:

  • None

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-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral abnormalities associated with cancer therapy.
Time Frame: Two years

A medical survey will be filled out with the patient and his legal guardian. A full dental examination will gather all clinical and radiographic findings. The following measures will be noted:

  1. Description of chemotherapy agents and duration
  2. Radiotherapy continuation.
  3. Radiotherapy dosage in Gray units.
  4. Yes/No questions regarding previous dental trauma.
  5. Yes/No questions regarding previous dental treatment.
  6. Questions regarding oral hygiene.
  7. Questions concerning oral habits.
  8. Extra oral examination.
  9. Intra oral clinical findings will be listed by tooth number.
  10. Radiographic findings will be listed by tooth number.
Two years

Collaborators and Investigators

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

Sponsor

Hadassah Medical Organization

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)

January 1, 2018

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 0004-16-HMO-CTIL

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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