Prevalence of Long-term Dental Effects of Chemotherapy in Childhood Cancer Survivors Diagnosed With Cancer Before the Age of 10

November 15, 2024 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

To date, there are no methods for assessing the risk of oral developmental defects that could predict long-term adverse effects in childhood cancer survivors. Having such a method at our disposal would enable us to better assess the risk to develop those defects and will help us provide new prevention and treatment strategies to ensure a healthy oral development.

The aims of this study are :

  • Assess the caries risk in childhood cancer survivors compared with a control group.
  • Assess the dental development defects risk in childhood cancer survivors compared with a control group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be an international study comparing the Childhood Cancer Survivors (CCS) and a control group.

A questionnaire will be provided to the patients to gather information. A standard of care dental examination will then take place in a dental office in the Cliniques Universitaires Saint-Luc. We also collect medical data to complete the files.

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

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 Locations

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age below 10 at cancer diagnosis (for the CCS group).
  • Chemotherapy must have been used to treat the patient (For the CCS group).
  • The patient is 12 years old or older at the time of the follow-up appointment of the present study

Exclusion Criteria:

  • A patient who was diagnosed and treated after 10 years old.
  • Patient below 12 years old at time of study recruitment
  • Patients with syndrome or diseases that involve teeth impairment*
  • Pregnant patient
  • Refusal or inaptitude to undergo dental and radiographic examination

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Diagnostic test: Clinical and radiographic dental examination
complete clinical oral examination + intra-oral and panoramic x-rays
Experimental: Cancer survivor
Diagnostic test: Clinical and radiographic dental examination
complete clinical oral examination + intra-oral and panoramic x-rays

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the caries experience by using the Decay Missing Filled Teeth score (DMFT)
Time Frame: Thoughout the entire study, approximately during 2 years
Assess the impact of the chemotherapy agents on the risk of ulterior caries development
Thoughout the entire study, approximately during 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the prevalence of dental development defects (DDD)
Time Frame: Thoughout the entire study, approximately during 2 years
Assess the impact of the chemotherapy agents on the risk of ulterior dental development defect
Thoughout the entire study, approximately during 2 years

Collaborators and Investigators

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

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Maëlle De Ville de Goyet, Cliniques Universitaires Saint-Luc

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 3, 2024

Primary Completion (Estimated)

May 3, 2026

Study Completion (Estimated)

May 3, 2026

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DENTAL CHEMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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