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

NCT06517927 | Recruiting

• 1 other identifier: DENTAL CHEMO
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy Effect; Dental Caries; Malocclusion; Childhood Cancer; Tooth Defect

Keywords

Childhood cancer survivors; Dental defect

Outcome Measures

Primary Outcomes (1)

• Assessment of the caries experience by using the Decay Missing Filled Teeth score (DMFT)

  Assess the impact of the chemotherapy agents on the risk of ulterior caries development

  Thoughout the entire study, approximately during 2 years

Secondary Outcomes (1)

• Assessment of the prevalence of dental development defects (DDD)

  Thoughout the entire study, approximately during 2 years

Study Arms (2)

Cancer survivor

EXPERIMENTAL

Diagnostic Test: Clinical and radiographic dental examination

Control

ACTIVE COMPARATOR

Diagnostic Test: Clinical and radiographic dental examination

Interventions

Clinical and radiographic dental examination DIAGNOSTIC_TEST

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

Cancer survivor; Control

Eligibility Criteria

• Age: 12 Years - 36 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Dental Caries; Malocclusion; Neoplasms

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Maëlle De Ville de Goyet

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armand IRAKOZE

CONTACT

027645741; armand.irakoze@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventionnal study, cohort study

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: May 3, 2024
• Primary Completion: May 3, 2026
• Study Completion: May 3, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)