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Dentomaxillofacial Paediatric Imaging: An Investigation Towards Low Dose Radiation Induced Risks

NCT02532127 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-11-24

No results posted yet for this study

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.

Conditions

  • Radiation Dosage

Interventions

OTHER

Saliva sampling

Cells will be collected from consenting participants just before and after (30 min and 24 hr) exposure to CBCT, by brushing a swab against the inner cheek, which can be done by the patients themselves. Swab kits are provided together with an envelope for sending the swabs back.

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • University of Paris 5 - Rene Descartes

    collaborator OTHER

  • Iuliu Hatieganu University of Medicine and Pharmacy

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-12-31
Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02532127 on ClinicalTrials.gov