Overview

This trial is active, not recruiting.

Condition radiation dosage
Treatment saliva sampling
Sponsor Universitaire Ziekenhuizen Leuven
Collaborator Katholieke Universiteit Leuven
Start date December 2014
End date December 2016
Trial size 50 participants
Trial identifier NCT02532127, S56942

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
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.
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.

Primary Outcomes

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

Eligibility Criteria

Male or female participants up to 22 years old.

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:

Additional Information

Official title Dentomaxillofacial Paediatric Imaging: An Investigation Towards Low Dose Radiation Induced Risks
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.