sâmbătă, 6 septembrie 2014

Ghidurile Europene pentru CBCT - partea a V - a



5:     CBCT EQUIPMENT FACTORS IN THE REDUCTION OF RADIATION RISK
        TO PATIENTS



The literature review in section 2.5 showed that the effective dose may vary significantly between different CBCT equipment. In this section, the significance of selection of appropriate exposure settings in limiting doses while maintaining the image quality at acceptable clinical levels (optimisation) is reviewed. Due account was given to any available national recommendations on CBCT optimisation (Haute Autorité de Santé, 2009; Health Protection Agency, 2010; Statens strålevern, 2010).

5.1: X-ray tube voltage and mAs



The kilovoltage (kVp) of an X-ray tube is the potential difference between anode and cathode during operation. The tube voltage determines the energy of the X-rays. Lower tube voltages give lower energy X-rays and thus increase the dose to the skin of the patient (Horner 1994). Increasing the kVp may result in a decrease in skin and effective dose (Geijer et al 2009) but an increase in scatter. Higher kVp, however, reduces the beam hardening effect (Ludlow 2011). More research is needed to explore the optimisation of kVp in CBCT. The product of the tube current measured in milliamperes (mA) and the exposure time measured in seconds (s) only affects the number of photons emitted by the X-ray tube and not their energy. Increased mAs increases dose, but the beam penetration and image contrast remain the same. The kVp and mA in dental CBCT equipment is either fixed or can be varied depending on the CBCT unit (Ludlow et al 2006; Lofthag-Hansen et al 2008; Silva et al 2008; Okano et al 2009; Roberts et al 2009). Fixed kVp and mA preclude optimisation.
The optimisation of radiation dose can be achieved by balancing exposure with image quality needs. Some diagnostic tasks necessitate higher levels of detail to others. The possibility of using “low dose” MSCT for certain tasks in head and neck radiology is established (Loubele et al 2005; Loftag-Hansen 2010). There is a lack of studies that attempt to optimise these two exposure factors for different CBCT units and clinical protocols. Where “low dose” options are available through reduction in mAs, large reductions in effective dose have been reported (Pauwels et al in press); although this study did not assess image quality, it used manufacturers‟ low dose protocols. Kwong et al (2008) found that mA and kVp could be reduced for the equipment studied without a significant loss of image quality. Sur et al 2010 investigated the effect of tube current reduction on image quality for presurgical implant planning in CBCT. They reported that substantial reductions in mA could be made without clinically significant loss of image quality. The work of Lofthag-Hansen et al (2010) also provides ample evidence for the scope for reductions in mAs with acceptable image quality, although they emphasised that exposure parameters should be adjusted to the diagnostic task in question. While these studies must be viewed as specific to the CBCT equipment in question, the weight of evidence in X-ray-based imaging in medicine, along with available national guidelines on optimisation (Haute Autorité de Santé, 2009; Health Protection Agency, 2010; Statens strålevern, 2010), is sufficiently strong to be able to make a recommendation:

KiloVoltage and mAs should be adjustable on CBCT equipment and must be optimised during use according to the clinical purpose of the examination, ideally by setting protocols with the input of a medical physics expert

B
 
5.2: Field of View and Collimation



CBCT units can be characterised by their Field of View (FOV). The FOV is a cylindrical or spherical volume and determines the shape and size of the reconstructed image. FOVs may vary from a few centimetres in height and diameter to a full head reconstruction. Several CBCT units offer a range of FOV, whilst a fixed FOV is provided by other units. Some CBCT machines offer the option to collimate the beam to the minimum size needed to image the area of interest. The size of the FOV is associated with radiation dose to the patient and staff (Hirsch et al 2008; Okano et al 2009; Roberts et al 2009; Lofthag-Hansen et al 2010; Pauwels et al in press).



The study by Pauwels et al (in press), conducted as part of the SEDENTEXCT project, demonstrated well the influence of FOV upon effective dose. As can be seen, while each class of FOV shows a wide range of effective dose, there is a clear trend for smaller FOVs to offer lower doses.


Reducing the size of the X-ray beam to the minimum size needed to image the object of interest is, therefore, an obvious means of limiting dose to patients, as well as improving image quality by scatter reduction. Based on the dosimetry evidence and the range of potential clinical applications of CBCT, the Panel judged that equipment with large, fixed FOV was inappropriate for general dental use, where diagnostic tasks are often localised to one, or a few teeth.

Multipurpose dental CBCT equipment should offer a choice of volume sizes and examinations must use the smallest that is compatible with the clinical situation if this provides less radiation dose to the patient

B BP
 
This recommendation applies to “multipurpose” dental CBCT equipment, used for a variety of clinical applications. In certain situations (e.g. specialised endodontic practice) it is likely that only small volume examinations would be required, and a single [small] field of view option would be appropriate.  

5.3: Filtration


Aluminium filtration is an established component of medical X-ray equipment. Some dental CBCT units are equipped with copper filtration. Filtration removes lower energy X-ray photons which results in skin dose reduction but also results in contrast loss (Ludlow et al 2006; Loftag-Hansen et al 2008; Silva et al 2008; Okano et al, 2009; Roberts et al 2009). Kwong et al (2008) found that addition of a copper filter did not affect overall image quality on the CBCT equipment studied. Ludlow (2011) demonstrated that increased copper filtration (in conjunction with a kV change) resulted in a substantial effective dose reduction. Qu et al (2010) cite another manufacturer who has chosen to add copper filtration in a move to optimise dose. Clearly these publications are specific to the equipment studied, and further work on optimising filtration in terms of material and thickness should be performed before a general recommendation can be made.




Research studies on optimisation of filtration for dental CBCT units should be performed

GP
 
5.4: Digital detector


Dental CBCT units are equipped with digital receptors where the image is captured and formed. Spatial and contrast resolution are important aspects of CBCT detectors which influence image quality.

Two types of digital detectors have been used for dental CBCT units (Hashimoto et al 2003; Ludlow et al 2003; Araki et al 2004; Pasini et al 2007; Loubele et al 2008; Ludlow & Ivanovic 2008; Roberts et al 2009). The first type involves conventional image intensifiers (II). They consist of an input window, input phosphor, photocathode, vacuum and electron optics, output phosphor and output window. The input phosphor converts the X-rays to optical photons which then are converted to electrons within the photocathode. The electrons are accelerated and focused by a series of electrodes and then strike the output phosphor which converts the electrons to light photons which are then captured by various imaging devices. Most modern image intensifiers have cesium iodide for the input phosphor because it is a very efficient material in absorbing X-rays.



The second type, flat panel detectors (FPDs), are composed of an X-ray detection layer and an active matrix array (AMA) of thin film transistors (TFT). The X-ray detector consists of a phosphor layer such as cesium iodide which converts the X-ray photons to light photons. The intensity of the light emitted by the phosphor is a measure of the intensity of the incident X-ray beam. The AMA has a photosensitive element which produces electrons proportional to the intensity of the incident photons. This electrical charge is stored in the matrix until it is read out and it is converted into digital data sent to the image processor. FPDs have greater sensitivity to X-rays than IIs and therefore have the potential to reduce patient dose (Kalender & Kyriakou 2007). They have higher spatial and contrast resolution and fewer artefacts than IIs but, in general, IIs are cheaper than FPDs.



The detector is an important element of the imaging chain and optimisation contributes to dose limitation. The detector is an important element of the imaging chain and optimisation contributes to dose limitation. Balancing the image quality and dose involves the assessment and optimisation of the detector‟s parameters with relation to dose in the context of image quality and would best be performed in conjunction with a medical physics expert as part of acceptance and commissioning testing (see Section 6.2.2) and in subsequent routine tests.


Dental CBCT units equipped with either flat panel detectors or image intensifiers need to be optimised in terms of dose reduction before use

GP
 
5.5: Voxel size


The volume element (voxel) represents a three-dimensional (3D) quantity of data and it can be pictured as a 3D pixel. The reconstructed image area or FOV consists of a number of voxels which are isotropic. The voxel size in CBCT systems may vary from less than 0.1 mm to over 0.4 mm (Hashimoto et al 2003; Loubele et al 2008; Liedke et al 2009). Scanning protocols with smaller voxel size are associated with better spatial resolution but with a higher radiation dose to the patient. Voxel size can influence diagnostic performance, with some tasks which require a high level of detail (see Section 4.3) having been shown to require smaller voxels to optimise diagnostic accuracy (Liedke et al 2009; Kamboroğlu & Kursun 2010; Wenzel et al 2009; Hassan et al 2010; Kamboroglu et al 2010; Melo et al 2010). Qu et al (2010) showed that the “low resolution” option on one CBCT machine substantially reduced patient dose. Clearly, when possible, a low resolution option should be preferred where the nature of the diagnostic task permits. An important consideration in clinical use is that, due to the long scanning times, it is likely that nominal spatial resolutions may not be achieved due to the high probability of motion during the scan.




Multipurpose dental CBCT equipment should offer a choice of voxel sizes and examinations should use the largest voxel size (lowest dose) consistent with acceptable diagnostic accuracy

C
 
As with section 5.2 (above), this recommendation applies to “multipurpose” dental CBCT equipment. In certain situations (e.g. specialised endodontic practice) it is likely that only high resolution, small volume, examinations would be required.

5.6: Number of projections


The rotation of the X-ray tube and the detector around the patient‟s head produces multiple projection images. The total number of acquired projections depends on the rotation time, frame rate (number of projections acquired per second) and on the completeness of the trajectory arc. A high number of projections is associated with increased radiation dose to the patient, higher spatial resolution and greater contrast resolution. Brown et al (2009) have shown that increasing the number of projections does not influence the linear accuracy of CBCT. Reducing the number of projections, while maintaining a clinically acceptable image quality, results in patient dose reduction through a reduction in exposure (mAs).
Some models of CBCT equipment offer the opportunity to perform partial rotations (e.g. 180º instead of the standard 360º), resulting in approximately 50% dose reductions to the patient. Some studies suggest that, for certain clinical applications on specific CBCT equipment, partial rotations can be used while maintaining acceptable diagnostic accuracy and image quality (Lofthag-Hansen et al 2010; Durack et al. 2011). Further research studies should look into the effect of the number of acquired images on the relationship between radiation dose and image quality.

Research studies should be performed to assess further the effect of the number of projections on image quality and radiation dose

GP
 
5.7: Shielding devices

An alternative way of reducing patient dose is by using shielding devices containing high attenuation materials, such as lead. The thyroid gland is a radiosensitive organ which may be affected by scattered radiation and, occasionally, primary beam in dental CBCT. In Section 2.5 (Fig.2.1) the thyroid gland dose was seen to be an important contributor to effective dose from CBCT, although how much of this is due to internal scatter, which would not be affected by external shielding, is unclear. Tsiklakis et al (2005) have observed a 20% decrease in effective dose by protecting the thyroid gland during CBCT, although this was with a large FOV scanner. In the UK, the guidance (Health Protection Agency 2010) states that the thyroid gland should not normally be in the primary beam during dental CBCT examinations and, therefore, that thyroid shielding should not be necessary. As large FOV scanners are in clinical use, the Panel felt that decisions on the possible value of thyroid shielding should be made locally, ideally with the input of the medical physics expert, depending on the likelihood of the thyroid lying in, or close to, the primary beam. This view is consistent with French guidance (Haute Autorité de Santé, 2009). There is no evidence for the routine use of abdominal shielding (“lead aprons”) during dental CBCT examinations, in line with recommendations for conventional dental radiography. 
  

Shielding devices could be used to reduce doses to the thyroid gland where it lies close to the primary beam. Care is needed in positioning so that repeat exposure is not required. Further research is needed on effectiveness of such devices in dose reduction

GP



5.8: References


Araki K, Maki K, Seki K, Sakamaki K, Harata Y, Sakaino R, Okano T, Seo K. Characteristics of a newly developed dentomaxillofacial X-ray cone beam CT scanner (CB MercuRay): system configuration and physical properties. Dentomaxillofac Radiol 2004; 33: 51-59.



Brown AA, Scarfe WC, Scheetz JP, Silveira AM, Farman AG. Linear accuracy of cone beam CT derived 3D images. Angle Orthod 2009; 79: 150-157.



Durack C, Patel S, Davies J, Wilson R, Mannocci F. Diagnostic accuracy of small volume cone beam computed tomography and intraoral periapical radiography for the detection of simulated external inflammatory root resorption. Int. Endod J.2011; 44:136-147.

Geijer H, Norrman E, Persliden J. Optimizing the tube potential for lumbar spine radiography with a flat-panel digital detector. Br J Radiol 2009; 82: 62-68


Hashimoto K, Arai Y, Iwai K, Araki M, Kawashima S, Terakado M. A comparison of a new limited cone beam computed tomography machine for dental use with a multidetector row helical CT machine. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2003; 95: 371-377.

Hassan B, Metska ME, Ozok AR, van der Stelt P, Wesselink PR.. Comparison of five cone beam computed tomography systems for the detection of vertical root fractures J Endod 2010; 36:126-129.

Haute Autorité de Santé. Tomographie Volumique a Faisceau Conique de la Face (Cone Beam Computerized Tomography). Rapport d‟évaluation Technologique. Service évaluation des actes professionnels. Saint-Denis La Plaine: Haute Autorité de Santé, 2009. http://www.has-sante.fr

Health Protection Agency. Guidance on the Safe Use of Dental Cone Beam CT (Computed Tomography) Equipment. HPA-CRCE-010. Chilton: Health Protection Agency, 2010

Hirsch E, Wolf U, Heinicke F, Silva MA. Dosimetry of the cone beam computed tomography Veraviewepocs 3D compared with the 3D Accuitomo in different fields of view. Dentomaxillofac Radiol 2008; 37: 268-273

Horner K. Review article: radiation protection in dental radiology. Br J Radiol 1994; 67: 1041-1049.
Kalender WA, Kyriakou Y. Flat-detector computed tomography (FD-CT). Eur Radiol. 2007; 17: 2767-2779.

Kamburoğlu K, Kursun S. A comparison of the diagnostic accuracy of CBCT images of different voxel resolutions used to detect simulated small internal resorption cavities. Int Endod J 2010; 43: 798-807.

Kamburoğlu K, Murat S, Yüksel SP, Cebeci AR, Paksoy CS. Detection of vertical root fracture using cone-beam computerized tomography: an in vitro assessment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010; 109: e63-69.
Kwong JC, Palomo JM, Landers MA, Figueroa A, Hans MG. Image quality produced by different cone-beam computed tomography settings. Am J Orthod Dentofacial Orthop. 2008; 133: 317-327.
Liedke GS, da Silveira HE, da Silveira HL, Dutra V, de Figueiredo JA. 2009. Influence of voxel size in the diagnostic ability of cone beam tomography to evaluate simulated external root resorption. J Endod 2009; 35: 233-235.

Lofthag-Hansen.Cone Beam Computed Tomography. Radiation Dose and Image Quality assessments. PhD thesis: Sahlgrenska Academy, University of Gothenburg, 2010.

Lofthag-Hansen S, Thilander-Klang A, Ekestubbe A, Helmrot E, Gröndahl K. Calculating effective dose on a cone beam computed tomography device: 3D Accuitomo and 3D Accuitomo FPD. Dentomaxillofac Radiol 2008; 37: 72-79

Lofthag-Hansen S, Thilander-Klang A, Gröndahl K. Evaluation of subjective image quality in relation to diagnostic task for cone beam computed tomography with different fields of view. Eur J Radiol. 2010 Oct 19. [Epub ahead of print]

Loubele M, Bogaerts R, Van Dijck E, Pauwels R, Vanheusden S, Suetens P, Marchal G, Sanderink G, Jacobs R. Comparison between effective radiation dose of CBCT and MSCT scanners for dentomaxillofacial applications. Eur J Radiol. 2009; 71: 461-468.

Loubele M, Jacobs R, Maes F, Schutyser F, Debaveye D, Bogaerts R, Coudyzer W, Vandermeulen D, van Cleynenbreugel J, Marchal G, Suetens P. Radiation dose vs. image quality for low-dose CT protocols of the head for maxillofacial surgery and oral implant planning. Radiat Prot Dosimetry. 2005; 117: 211-216.
Ludlow JB. A manufacturer's role in reducing the dose of cone beam computed tomography examinations: effect of beam filtration. Dentomaxillofac Radiol. 2011; 40: 115-122.

Ludlow JB, Davies-Ludlow LE, Brooks SL. Dosimetry of two extraoral direct digital imaging devices: NewTom cone beam CT and Orthophos Plus DS panoramic unit. Dentomaxillofac Radiol 2003; 32: 229-234.

Ludlow JB, Davies-Ludlow LE, Brooks SL, Howerton WB. Dosimetry of 3 CBCT devices for oral and maxillofacial radiology: CB Mercuray, NewTom 3G and i-CAT. Dentomaxillofac Radiol 2006; 35: 219-226

Ludlow JB, Ivanovic M. Comparative dosimetry of dental CBCT devices and 64-slice CT for oral and maxillofacial radiology. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2008; 106:106-114.

Melo SL, Bortoluzzi EA, Abreu M Jr, Corrêa LR, Corrêa M. Diagnostic ability of a cone-beam computed tomography scan to assess longitudinal root fractures in prosthetically treated teeth. J Endod. 2010; 36:1879-1882.

Okano T, Harata Y, Sugihara Y, Sakaino R, Tsuchida R, Iwai K, Seki K, Araki K. Absorbed and effective doses from cone beam volumetric imaging for implant planning. Dentomaxillofac Radiol 2009; 38: 79-85.

Pasini A, Casali F, Bianconi D, Rossi A and Bontempi M. A new cone-beam computed tomography system for dental applications with innovative 3D software. Int J CARS 2007;1: 265-273.

Pauwels R, Beinsberger J, Collaert B, Theodorakou C, Rogers J, Walker A, Cockmartin L, Bosmans H, Jacobs R, Bogaerts R, Horner K The SEDENTEXCT Project Consortium.
Effective dose range for dental cone beam computed tomography scanners. Eur J Radiol. 2010 Dec 31. [Epub ahead of print]

Qu XM, Li G, Ludlow JB, Zhang ZY, Ma XC. Effective radiation dose of ProMax 3D cone-beam computerized tomography scanner with different dental protocols. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010; 110: 770-6.

Roberts JA, Drage NA, Davies J, Thomas DW. Effective dose from cone beam CT examinations in dentistry. Br J Radiol 2009; 82: 35-40.
Scarfe WC, Levin MD, Gane D, Farman AG. Use of cone beam computed tomography in endodontics. Int J Dent 2009; 2009:634567. Epub 2010 Mar 31.

Silva MA, Wolf U, Heinicke F, Bumann A, Visser H, Hirsch E. Cone-beam computed tomography for routine orthodontic treatment planning: a radiation dose evaluation. Am J Orthod Dentofacial Orthop 2008; 133: 640.e1-5.

Sur J, Seki K, Koizumi H, Nakajima K, Okano T. Effects of tube current on cone-beam computerized tomography image quality for presurgical implant planning in vitro. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010; 110: e29-33

Statens strålevern. Stråleverninfo 8:2010. Krav for bruk av Cone Beam CT ved odontologiske virksomheter. Østerås: Statens strålevern, 2010.

Tsiklakis K, Donta C, Gavala S, Karayianni K, Kamenopoulou V, Hourdakis CJ. Dose reduction in maxillofacial imaging using low dose Cone Beam CT. Eur J Radiol 2005; 56: 413-417.

Wenzel A, Haiter-Neto F, Frydenberg M, Kirkevang LL. Variable-resolution cone-beam computerized tomography with enhancement filtration compared with intraoral photostimulable phosphor radiography in detection of transverse root fractures in an in vitro model. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009; 108: 939-945. 



6: QUALITY STANDARDS AND
QUALITY ASSUTANCE

6.1 Quality assurance programme


The purpose of Quality Assurance (QA) in dental radiology is to ensure consistently adequate diagnostic information, while radiation doses are controlled to be as low as reasonably achievable.

A well-designed QA programme should be comprehensive but inexpensive to operate and maintain for the dentist and staff. It should cover all aspects of the imaging process, including objective measures of the imaging equipment performance, patient dose audit and an assessment of clinical image quality. Such a programme will include the following:



• Performance of the X-ray tube and generator

• Quantitative assessment of image quality

• Display screen performance

• Patient dose assessment
• Clinical image quality assessment
• Clinical audit

Those aspects of the programme that deal primarily with equipment performance and patient dose are commonly referred to as quality control (QC). A QC programme will include surveys and checks that are performed according to a regular timetable. A written record of this programme should be maintained by staff to ensure adherence to the programme and to raise its importance among staff. A specific person should be named as leader for the QC programme.
In addition, assessment of the clinical images and other clinical audit should be undertaken on a regular basis to confirm that the equipment is being used correctly to produce clinically useful images.
In preparing this Section, due account was given to relevant sections of published national guidelines on dental CBCT in Belgium (Advies van de Hoge Gezondheidsraad, 2011), Denmark (Sundhedsstyrelsen, 2009), France (Haute Autorité de Santé, 2009), Germany (Leitlinie der DGZMK, 2009), Norway (Statens strålevern, 2010) and the United Kingdom (Health Protection Agency, 2010a and 201b).


6.2: Equipment performance


A programme of testing X-ray equipment performance is a requirement of the European Union Medical Exposures Directive (Council Directive 97/43/Euratom, 1997) as part of the optimisation process to ensure patient dose is as low as reasonably achievable whilst achieving clinically adequate image quality. The rationale for maintenance and testing of a dental CBCT system is similar to that of other dental systems (European Commission 2004) and for X-ray equipment in general (IPEM91 2005) and will consist of a critical examination and acceptance and commissioning testing when first installed, followed by routine testing throughout the life of the equipment. As both patient and operator dose are potentially higher than for traditional dental X-ray equipment, greater care is required for dental CBCT in all aspects of an equipment QC programme.

Ideally, any practice undertaking medical exposure should have access to the advice of a qualified expert for advice on radiation protection and a medical physics expert for advice on patient dose optimisation and equipment testing. Their help and advice should be sought in devising a suitable equipment testing regime. In some countries, there is no requirement for the appointment of a medical physics expert to dental practices using CBCT, for example in Denmark (Sundhedsstyrelsen, 2009) and Germany. The Panel suggest, however, that the relative radiation dose implications of some CBCT systems are such that it would be advisable to have a formal arrangement to obtain MPE advice.

Preliminary guidance on testing dental CBCT is now available, both within these Guidelines (Appendix 4) and from the UK (HPA 2010a) outlining the basic tests to be undertaken, both when the equipment is first installed and then on a regular basis throughout the life of the equipment. The QC protocol developed by the SEDENTEXCT project is given in Appendix 4 to these guidelines.


Suggested performance guidelines are also provided so that users can assess whether their unit is operating consistently and in line with expectation for these types of units. However, it should be remembered that this technology is still relatively new and is developing rapidly. The tests and performance guidelines should be kept under critical review and may well be subject to change as experience is gained in testing such units.

Some of the tests require specially devised phantoms. Such phantoms are commercially available, including that developed during the SEDENTEXCT project (Leeds Test Objects Ltd., Boroughbridge, UK). Some manufacturers of dental CBCT systems also provide a quality assurance phantom with their system, which should come with recommendations on the tests that should be performed, the best way to perform them, how often they should be performed and how the results should be interpreted. Some of these quality assurance phantoms, including the SEDENTEXCT phantom, are also provided with software which automatically performs analysis of the acquired image.




Published equipment performance criteria should be regularly reviewed and revised as greater experience is acquired in testing dental CBCT units

GP
 
6.2.1 Critical examination

A critical examination of the installation is required to ensure that all safety features are correctly installed and functioning and that adequate protection is provided to the operator and anyone else who may be in the area. This will usually be more onerous than for other dental equipment due to the higher protection requirements, both in terms of structural protection and warning systems. As expanded in Section 7.2, the structural protection required for a dental CBCT system is greater than for conventional dental imaging equipment and greater care must be taken in the room design to ensure adequate protection for both operator and others in areas adjacent to the unit. In particular, it cannot be assumed that CBCT systems can be installed in rooms designed for intraoral and panoramic dental systems without further work being undertaken. 

6.2.2 Acceptance and commissioning tests

The main aim of the acceptance and commissioning tests is to ensure the imaging system is as specified and working at an acceptable performance level for the specific clinical indications in the local practice. These tests should usually be performed by a medical physics expert. 

The essential content of these tests includes:



·         testing of equipment performance parameters

·         acquiring base line values for future routine tests

·         verification of how the systems are pre-programmed for use in practice



All acceptance and commissioning testing protocols include tests of the X-ray tube output, voltage consistency and accuracy, filtration, exposure time and radiation field. These can be tested in the same way as for other modalities, like general radiology digital detector systems or MSCT scanners. A dosimeter with wave form display may be helpful to confirm correct operation of the X-ray tube. Testing of the correct operation of any automatic exposure control device, if fitted, is also essential.
Classical tests of digital detectors (linearity, homogeneity, spatial resolution, low contrast resolution, (dark) noise, etc.) can be run if unprocessed raw data of the projective images are available. Reconstruction software can be tested indirectly via an assessment of image quality, using test objects with specific inserts. At present, there are no standardized reconstruction software tools available that would allow comparative studies among modalities. With ever more sophisticated acquisition schemes (like variable angles, off-axis radiation, tube output modulation, different FOVs, etc.) it is very unlikely that the reconstruction software will be standardized in the future. 

6.2.3 Routine tests 


Both medical physics experts and local personnel have a role in routine tests. A typical frequency for medical physics tests is annually (Health Protection Agency 2010a, 2010b; Statens strålevern, 2010). Local personnel should run a series of routine consistency tests more frequently in line with current national guidance, usually monthly (Qualitätssicherungs-Richtlinie, 2004; Health Protection Agency 2010a, 2010b; Statens strålevern, 2010). When introducing a new modality, its operation should be monitored more frequently, until the system is working reliably at its optimal point in terms of dose and image quality. Optimisation studies may be advisable at this stage.



Routine testing may be helped with automatic procedures built into the system. These can include the evaluation of test objects against performance levels set by the company or by national or international protocols, the review of retakes (automatically stored into the system) and system self checks. Full documentation should be provided by the installers on these (automated) procedures. Exportable reports are preferable.



A simple but very sensitive test for constancy checks in digital imaging is a regular acquisition of a homogeneous block of material. Local artefacts in the digital detector induce (usually circular) artefacts in the reconstructed slices. Tube- or detector-related instabilities would produce variations in signal intensities.

It is important that the performance of the display equipment and environment is also monitored, as well as the X-ray equipment and detectors, as these can lead to significant degradation of the image being used by the clinician.


Testing of dental CBCT should include a critical examination and detailed acceptance and commissioning tests when equipment is new and routine tests throughout the life of the equipment. Testing should follow published recommendations and a Medical Physics Expert should be involved.

ED BP
 
6.3 Patient dose 


An objective of the QA programme is to ensure doses are kept as low as reasonably achievable. It is, therefore, necessary to ensure that patient doses are monitored on a regular basis and compared to agreed standards. Standard dose levels are normally referred to as Diagnostic Reference Levels (DRLs) as described in the European Guidelines No 136 (European Commission 2004).



6.3.1 Dose quantities 



Dose quantities that are to be used for the regular assessment of patient dose must be relatively easy to measure in a clinical situation. Although effective dose is usually considered to be the best overall descriptor of patient dose, it can not be readily measured and a simpler quantity is required for routine dose audit. Entrance surface dose (ESD) and dose area product (DAP) are quantities that are routinely used in conventional radiology (European Commission 1999). In the field of CT, the computed tomography dose index (CTDI), and dose length product, DLP, are routinely used. Ideally, the dose quantity used should give a good correlation to the effective dose and hence overall patient risk.



In the UK, the Health Protection Agency has proposed the use of DAP (HPA 2010). This is promising as it provides one reading per exposure that gives an indication of both the dose level in the beam and the area irradiated. Some CBCT units already provide this information after each exposure. If this became universal, as CT scanners now all provide an indication of DLP, it would greatly facilitate patient dose audit. The accuracy of such readouts should be checked by the medical physics expert during routine testing.

Alternative proposals have been explored by the SEDENTEXCT team and dose indices based on point measurement within PMMA phantoms have been proposed (see patient dose section in Appendix 4). Further work is, however, required to establish whether such indices are appropriate for the setting of DRLs.


Manufacturers of dental CBCT equipment should provide a read-out of Dose-Area-Product (DAP) after each exposure

D
 
6.3.2 Establishing Diagnostic Reference Levels 


The UK‟s Health Protection Agency have carried out a preliminary audit of DAP across 41 dental CBCT units and have proposed an achievable dose of 250 mGy cm2 for CBCT imaging appropriate for the placement of an upper first molar implant in a standard adult patient. It should be noted that large FOV units in the sample exceed this and the dose audit data had been normalised to an area corresponding to a 4cm x 4cm field of view at the isocentre of the equipment. It is for this reason that they have referred to this dose level as an “achievable dose” rather than a DRL. It is indicative of the dose that should be achieved if using a CBCT unit suitable for this clinical use. Some dental implant systems require “full arch” imaging as part of the needs for manufacture of imaging guides/stents. Authorities or clinicians performing dose audit should specify that this requirement should be suspended for the dose measurement and the smallest field of view compatible with single implant site assessment used.

They also propose setting a DRL for a child view based on the clinical protocol used to image a single impacted maxillary canine in a 12 year old male. As yet, however, insufficient audit data is available to set this level.


Further work involving large scale audits is needed to establish robust DRLs for a range of dental CBCT applications that can aid in the patient dose optimisation process.  

Until further audit data is published, the panel recommend the adoption of an achievable Dose Area Product of 250 mGy cm2 for CBCT imaging for the placement of an upper first molar implant in a standard adult patient

D
 
6.3.3 Using DRLs 


Dentists should be aware of their average doses for the different types of examinations they undertake with their CBCT equipment and how these compare with the European and any national DRLs, once established.



If a DAP readout is provided on the equipment, the dentist should undertake audit of DAP readings for standard size patients, ideally with the help of a medical physics expert. If DAP is not provided it is expected that the dentist will need to seek help from the medical physics expert to establish typical patient doses. These assessments should be carried out on a regular basis, at least every three years or as required by national legislation.



These measurements can be seen to be a part of any QA programme adopted by the dental practice. Dose results that exceed established DRLs, or which significantly differ from previous audits, should be investigated with the help of a medical physics expert. Any resulting recommendations should be implemented.



It should be noted that CBCT units with fixed large FOV are likely to exceed the achievable dose stated above for the placement of an upper first molar implant in a standard adult patient. Consideration must be given as to whether the use of such a unit for this view can be considered to be justified.


A cone beam dental system usually comes with pre-programmed settings for different types of patients (e.g. children versus adults) or clinical indications. In the absence of any patient specific tube output modulation, the pre-programmed protocols can be verified by means of dose measurements in air, at the level of the detector, or using a DAP meter. In the ideal case, the dose measurements are performed for all standard imaging protocols for which a DRL has been defined. When tube output modulation is used, dedicated phantoms may be required or clinical dose audit based on a group of standard patients.



It is good practice to investigate whether the doses have been selected based upon relevant criteria. In particular, it should be verified that doses for children are significantly lower than those for adults and that separate programs are available for local pathologies as well as imaging the complete upper or lower jaw. Other settings to be tested include the correct pre-programming of lower kV, the use of tube output modulation, high versus low resolution scanning etc.

Systematic patient dose surveys are straightforward if DICOM header tags are completely filled in and if software is available to obtain the dose related information automatically. The intrinsic dose information has first to be checked against measured data, has then to be expressed or recalculated into survey related quantities and then be collected over a period of time. The medical physics expert should ensure that the practitioner is aware if DRLs are exceeded.

6.4: Clinical Image Quality Assessment


The consistent production of adequate diagnostic information from radiological examinations is central to optimization (EC Directive 97/43 Euratom). There is, however, ample research evidence showing that radiographic image quality is often less than ideal in primary dental care (reviewed in European Commission 2004). The higher radiation doses of CBCT compared with conventional dental radiography mean that standards must be rigorously maintained.

In addition to the assessment of image quality by quantitative methods, as described above in the image quality section, it is important that the quality of clinical images is assessed. This can be approached in three ways:

1. Comparison with standard reference images from high quality CBCT examinations.

2. Reject analysis, in which the rate of unsuccessful CBCT examinations is recorded and the reasons for rejection analysed.
3. Systematic audit of CBCT examinations against established clinical image quality criteria.

Assessment of the clinical quality of images should be a part of a quality assurance programme for CBCT

GP
 
6.4.1 Comparison with standard reference images 

This is a long-established method of continuous monitoring of clinical image quality and helps to guard against a gradual drift away from optimal quality which may occur in practice over time. A CBCT scan dataset of excellent quality is used as a reference, against which everyday clinical scans can be assessed. Because of readily apparent differences in the appearance of CBCT datasets produced by different CBCT machines, reference scans need to be prepared which are specific to each machine. This might best be done by the manufacturer and supplied with the equipment. There is, however, a potential conflict between this approach for assessing image quality and optimization efforts which may employ reduced exposures that are sufficient to achieve adequate image quality for the clinical task. Thus, adequate quality images may fall short of the quality of an excellent reference image. As such, standard reference CBCT scan datasets should be available which are specific not only to the machine, but also to the diagnostic task.

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