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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742363
• Other study ID #: 0004-16-HMO-CTIL
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: January 2023
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 32 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Collecting data
Collecting data from patient records

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral abnormalities associated with cancer therapy.	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: Description of chemotherapy agents and duration; Radiotherapy continuation.; Radiotherapy dosage in Gray units.; Yes/No questions regarding previous dental trauma.; Yes/No questions regarding previous dental treatment.; Questions regarding oral hygiene.; Questions concerning oral habits.; Extra oral examination.; Intra oral clinical findings will be listed by tooth number.; Radiographic findings will be listed by tooth number.	Two years