Clinical trial NCT02532127: Dentomaxillofacial Paediatric Imaging: An Investigation Towards Low Dose Radiation Induced Risks
Official title: Dentomaxillofacial Paediatric Imaging: An Investigation Towards Low Dose Radiation Induced Risks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Dosage
Keywords: Low-dose risk
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: University of Paris 5 - Rene Descartes
name: Iuliu Hatieganu University of Medicine and Pharmacy
First posted: 2015-08-25
Enrollment: 50
Sex: ALL
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cone Beam Computed Tomography (CBCT) is an emerging X-ray technology that has found wide applications in dentomaxillofacial imaging. The ability to provide high-resolution 3D images has resulted in a significant increase in the volume of dental radiology procedures. Although CBCT is associated with higher radiation risk to the patient than conventional dental X-ray imaging (intraoral or panoramic), it is considered to be 'low dose' imaging as defined by the High Level Expert Group (HLEG) with doses ranging from a few microsieverts (μSv) to millisieverts (mSv) per examination.

This proposal is set to tackle important issues raised by the HLEG and the Multidisciplinary European Low Dose Initiative (MELODI) platform. In particular, as deduced by the name DIMITRA (Dentomaxillofacial paediatric imaging: an investigation towards low dose radiation induced risks), the project focuses on the uncertainties associated with radiation-induced health risks at low doses in paediatric dentistry and is a multidisciplinary effort to approach the involved risks from different yet interrelated perspectives: radiobiological characterisation, dosimetric quantification, epidemiological surveying and image quality \& dose optimization. A unique Monte Carlo simulation (MC) framework will be used to accurately calculate organ doses in dental CBCT imaging, to quantify the radiation induced risk and to feed the radiobiology team with the appropriate data towards the identification, development and validation of biomarkers for radiation induced health effects. Furthermore, it will constitute the basis upon setting up a gender and age related epidemiology study. The balance between image quality and dose levels will be explored aiming at reducing the risk through image quality optimization.

It is expected that DIMITRA's outcomes and deliverables can be presented to a wider forum via a dissemination meeting, leading to further recommendations and potential future adaptations for the use of CBCT in paediatric dentistry.


Eligibility criteria: Inclusion Criteria:

* Prospective study with saliva sampling: Patients referred for a CBCT scan from their doctor
* Retrospective study: recorded patients (age 0 - 22) referred to UZ Leuven in the last 2 years including cleft palate patients

Exclusion Criteria:

-

Primary outcomes:
measure: Patient-specific dosimetry
timeFrame: dose retrospectively calculated for each patient up to 1 week after irradiation, patients will be followed until the end of the study (May 2017)
measure: Saliva sampling
timeFrame: 30 minutes before radiation
measure: Identify and develop biomarkers for radiation-induced health effects
timeFrame: 24 hours after CBCT radiation
Secondary outcomes:
Other outcomes:
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Study officials:
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