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

Not Applicable

Recruiting

• Conditions: Chemotherapy Effect; Malocclusion; Tooth Defect; Dental Caries; Childhood Cancer
• Interventions: Diagnostic Test: Clinical and radiographic dental examination

• Registration Number: NCT06517927
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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.

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 Timeline

• Study Start: 2024-05-03
• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2026-05-03
• Study Completion: 2026-05-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cancer survivor	Clinical and radiographic dental examination	-
Control	Clinical and radiographic dental examination	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of the prevalence of dental development defects (DDD)	Thoughout the entire study, approximately during 2 years	Assess the impact of the chemotherapy agents on the risk of ulterior dental development defect

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium