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

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT02532127

Collaborator

KU Leuven (Other), University of Paris 5 - Rene Descartes (Other), Iuliu Hatieganu University of Medicine and Pharmacy (Other)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiation Dosage	Other: Saliva sampling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Other: Saliva sampling

Outcome Measures

Primary Outcome Measures

Patient-specific dosimetry [dose retrospectively calculated for each patient up to 1 week after irradiation, patients will be followed until the end of the study (May 2017)]
Using a Monte-Carlo based simulator, specifically designed for dental CBCT imaging, adjusted towards specific CBCT geometries and a series of realistic voxel models of paediatric patients will allow the assessment of variability in doses due to differences in anatomy between patients. The organ and effective doses are used for calculating the associated age and gender related cancer risks attributable to dental and maxillofacial CBCT scans.
Saliva sampling [30 minutes before radiation]
Identify and develop biomarkers for radiation-induced health effects [24 hours after CBCT radiation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven
KU Leuven
University of Paris 5 - Rene Descartes
Iuliu Hatieganu University of Medicine and Pharmacy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT02532127

Other Study ID Numbers:

S56942

First Posted:

Aug 25, 2015

Last Update Posted:

Nov 24, 2021

Last Verified:

Nov 1, 2021

Keywords provided by Universitaire Ziekenhuizen Leuven

Low-dose risk

Study Results

No Results Posted as of Nov 24, 2021