Radiation DosageDIMITRANCT02532127
Dentomaxillofacial Paediatric Imaging: An Investigation Towards Low Dose Radiation Induced Risks
A study testing Saliva sampling in people with Radiation Dosage, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Radiation Dosage
- What is being tested?
- Saliva sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- -
About this study
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
- Being tested
- Saliva sampling
- Keywords
- Low-dose risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Saliva sampling | 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. Receives: Other: Saliva sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-specific dosimetry
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.
Measured: 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
Measured: 30 minutes before radiation
Identify and develop biomarkers for radiation-induced health effects
Measured: 24 hours after CBCT radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DosageStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, University of Paris 5 - Rene Descartes, Iuliu Hatieganu University of Medicine and Pharmacy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532127
- Sponsor's protocol ID
- S56942
- Acronym
- DIMITRA
- Status last verified
- Nov 2021
- First submitted
- 10 Dec 2014
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentomaxillofacial Paediatric Imaging: An Investigation Towards Low Dose Radiation Induced Risks
- ClinicalTrials.gov ID
- NCT02532127
- Acronym / sponsor ID
- DIMITRA / S56942
- Conditions
- Radiation Dosage
- Keywords
- Low-dose risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven, University of Paris 5 - Rene Descartes, Iuliu Hatieganu University of Medicine and Pharmacy
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 25 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saliva sampling | Experimental | Other: Saliva samplingCells 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. |
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva samplingCells 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 |
Primary outcome
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)
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
Time frame: 30 minutes before radiation
Identify and develop biomarkers for radiation-induced health effects
Time frame: 24 hours after CBCT radiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Saliva sampling in people with Radiation Dosage, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.