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NCT Number: NCT06517927

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

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.

Recruiting

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Key information

Age range

12 year–36 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location status: Recruiting

Location contact

Maëlle De Ville de Goyet

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical and radiographic dental examination

Diagnostic Test

complete clinical oral examination + intra-oral and panoramic x-rays

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Armand IRAKOZE

CONTACT

[email protected]

027645741 ext. +32

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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