Rethinking Risk and Benefit in Dental and Maxillofacial Imaging Dose matters



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Rethinking Risk and Benefit in Dental and Maxillofacial Imaging Dose matters John B Ludlow, DDS, MS, FDS RCSEd University of North Carolina, Chapel Hill, NC Background Radiation risk is frequently front page news recent example - Japan s Fukushima Nuclear Plant following an Earthquake & Tsunami - 3/11/2011 Our patients are concerned and often confused about risk associated with different exposures We can help by being well informed 1

Learning objectives: Identify the risks from ionizing radiation Describe options in CBCT units which affect dose Discuss importance of matching options to objectives of imaging Explore ways to reduce patient risk Explain how to talk about risks with patients What are the risks? Gamma bomb exposure Radioactive spider bite 2

Stochastic vs Deterministic Effects Stochastic effects A linear-no-threshold hypothesis of x ray risk fits most data for cancer development but is extrapolated to doses below 100 mgy (adult exposure) 10-20 mg (fetal exposure) No expressions of germ cell mutations have been observed in human populations Deterministic effects (Non stochastic effects) Threshold for in-utero birth defects 100-250 msv Cataracts 2-5 Gy radiation burns 3 Gy (reddening) radiation mucositis 30+ Gy (therapy typically 60-80 Gy) Source contribution to total effective dose (6.2 msv) per capita in the US - 2006 From NCRP REPORT No. 160, 2009 Source % µsv Ubiquitous background 50 3100 Medical 48 2976 Consumer 2 124 6 3

CT procedures per year - US Annual growth of >10% per year From NCRP REPORT No. 160, 2009 Background NEJM 11-29-2007 Computed Tomography An Increasing Source of Radiation Exposure David Brenner, et al. From 1.5% to 2% of all cancers in the United States may be attributable to the radiation from CT studies 4

Background: CT & CBCT Effective Doses (2007 ICRP) Large FOV CBCT scans 68 1073 µsv Medium FOV CBCT scans 69 560 µsv Small FOV CBCT scans 189 652 µsv Medium FOV MDCT scans 534 860 µsv Ludlow JB, Ivanovic M. Comparative Dosimetry of Dental CBCT Devices and 64 row CT for Oral and Maxillofacial Radiology Oral Surg Oral Med Oral Pathol Oral Radiol Endodont 2008;106:930-938 Dose and Risk Estimation 1990 Recommendations of the International Commission on Radiological Protection Effective dose calculation (Sv) Summed doses to weighted organs & tissues known to be most susceptible to radiation damage Mathematical expression: E = w T x H T 5

ICRP 2007 Recommendations 2007 Recommendations of the ICRP Reassessment of Risk based on cancer incidence data from the Life Span Study of Japanese atomic bomb survivors Revision of list of tissues Adjustment of weights Effective dose: E = w T x H T Tissue weighting factors for calculation of Effective Dose Comparison of 1990 and 2007 ICRP Recommendations * Adrenals, brain, upper large intestine, small intestine, kidney, muscle, pancreas, spleen, thymus, uterus Adrenals, Extrathoracic region, Gall bladder, Heart, Kidneys, Lymphatic nodes, Muscle, Oral Mucosa, Pancreas, Prostate, Small Intestine, Spleen, Thymus, and Uterus/cervix. 1. 1990 Recommendations of the ICRP. Publication 60. Ann ICRP 1991; 21: 1-201 2. 2007 Recommendations of the ICRP. Publication 103. Ann ICRP 2007; 37: 1-332 2007 2 Tissue 1990 1 w T w T Bone marrow 0.12 0.12 Breast 0.05 0.12 Colon 0.12 0.12 Lung 0.12 0.12 Stomach 0.12 0.12 Bladder 0.05 0.04 Esophagus 0.05 0.04 Gonads 0.20 0.08 Liver 0.05 0.04 Thyroid 0.05 0.04 Bone surface 0.01 0.01 Brain remainder 0.01 Salivary glands - 0.01 Skin 0.01 0.01 Remainder Tissues 0.05* 0.12 6

Summary of changes ICRP 1990 2007 4 additional weighted tissues 10% increase in weight of tissues located in maxillofacial area 28% increase in weight adjusted for distribution of tissues in maxillofacial area 3 of the newly weighted tissues are entirely within the maxillofacial area: oral mucosa, extrathoracic region, and salivary glands Effective Dose and Detriment (Risk) Calculation Detriment includes the weighted probabilities fatal and non-fatal cancer relative length of life lost hereditary effects Cancer risk alone may be used for the 2007 ICRP risk estimates for dental radiography Cancer Risk = E(Sv) x 0.055 Cancer risks for children are 2 or more times greater than for adults 7

How do we measure dose? Effective Dose calculation preferred Human phantom studies Expensive Simple acrylic phantoms CTDI VOL Easy but inaccurate Monte Carlo modeling Promising but model and software dependent Dose area Product x coefficient for head/neck exposure Easy but inaccurate RANDO Level 6 Levels 2 3 4 5 6 7 9 8

Fields of view Large Medium Small > 15 cm 10-15 cm < 10 cm Dental CBCT units available in the US Small FOV Medium FOV Large FOV Unit Name Company Unit Name Company Unit Name Company Picasso Trio VaTech NewTom Vgi AFP Imaging NewTom 3G AFP Imaging Accuitomo 80 J. Morita Reve 3D VaTech Alphard 3030 Belmont / Asahi Veraview-epocs 3D J. Morita CB-500 Gendex Master 3DS VaTech 9000 3D Kodak 9500 3D med FOV Kodak i-cat Next Gen Imaging Sciences Int Skyview 6 FOV My-Ray Accuitomo 170 J. Morita Ilumina Imtech / 3M Promax CBCT Planmeca Skyview 9 FOV My-Ray 9500 3D large FOV Kodak Orion Ritter Imaging Scanora 3D med FOV Soredex Promax 3D Max Planmeca Suni 3D Suni Galileos Comfort Sirona NewTom 9000* QR Verona Prexion TeraRecon Galileos Compact Sirona i-cat Classic* Imaging Sciences Int Auge Zio OP 300 3D Asahi Roentgen Intrumentarium CB Mercuray* Hitachi Medical * No longer manufactured Orthophos XG 3D Sirona 9300 Kodak 15 manufacturers 32 units since 2000 (as many as 40 unit variations world-wide) 9

Field of view Note that detector sizes need to be larger than the FOV due to image magnification Image Intensifiers produce spherical FOVs Flat panels produce cylendrical FOVs Cylinders typically provide larger useful FOVs than spheres. Cylinder height Sphere diameter Large FOV Units ex: Kodak 9500 60-90 kv 2-15 ma Pulsed Flat Panel large FOV version (18 cm x 20 cm) 10

Large FOV CBCT Dose Calculations (Based on ICRP 2007 Recommendations) Large FOV Techniques Effective Dose in µsv Dose as multiple of average Panoramic Dose Days of per capita background* Probability of x in a million fatal cancer NewTom3G Large FOV 68 4 8 4 CB Mercuray Facial FOV (maximum quality) 1073 67 131 59 CB Mercuray Facial FOV (standard quality) 569 35 69 31 i-cat Classic Extended Field 70 4 8 4 Next Generation i-cat Portrait mode 74 5 9 4 Kodak 9500 21 cm x 18 cm (medium adult) 163 10 20 9 Iluma (standard) 98 6 12 5 7.7X Iluma (ultra) 498 31 61 27 SCANORA 3D dual scan 125 8 15 7 *3,000 µsv, NCRP Report No. 145, 2003 Average of 5 units dose in µsv x 5.5x10-2 Medium FOV units ex: Kodak 9500 60-90 kv 2-15 ma Pulsed Flat Panel medium FOV version (9 cm x 15 cm) 11

Medium FOV CBCT Dose Calculations (Based on ICRP 2007 Recommendations) Medium FOV Techniques Effective Dose in µsv Dose as multiple of average Panoramic Dose Days of per capita background* Probability of x in a million fatal cancer CB Mercuray Panoramic FOV 560 35 68 30.8 Classic i-cat Standard scan 69 4 8 3.8 Next Generation i-cat Landscape mode 87 5 11 4.8 Galileos (default exposure) 70 4 9 3.9 SCANORA 3D large FOV 76 5 9 4.2 Newtom VG 109 7 13 6.0 CB-500 extended diameter scan 89 6 11 4.9 Kodak 9500 9 cm x 15 cm (medium adult) 98 6 12 5 Somaton 64 MDCT 860 53 105 47.3 Somaton 64 MDCT w/ CARE Dose 4D 534 33 65 29.4 *3,000 µsv, NCRP Report No. 145, 2003 Average of 5 units dose in µsv x 5.5x10-2 12X Small FOV Units ex: Kodak 9000 3D Panoramic unit Sensor switches from pan to 3D electronically Volume size: 3.7 cm x 5 cm Voxel size 67 µm CMOS w/ optical fiber 60-90 kv 2-15 ma Pulsed 16 bit 12

Small FOV CBCT Dose Calculations (Based on ICRP 2007 Recommendations) Small FOV Techniques CB Mercuray I FOV (maxillary) CB-500 8 cm x 8 cm Standard 0.3 or 0.4 mm Orthophos XG 3D 8 cm x 8 cm (medium adult) Promax 3D 8 cm x 8 cm (medium adult) PreXion 3D 8 cm x 8 cm (standard exposure) OP300 8 cm x 6 cm FOV Standard dose & res SCANORA 3D 6 cm x 6 cm (avg sextant) Kodak 9000 4 cm x 5 cm (avg sextant) Effective Dose in µsv Dose as multiple of average Panoramic Dose Days of per capita background* Probability of x in a million fatal cancer 407 25 50 22 115 7 14 6 64 4 7 4 216 30 59 27 189 12 23 10 66 4 8 4 38 3 6 3 21 1 2 1 6.4X *3,000 µsv, NCRP Report No. 145, 2003; Average of 5 units; dose in µsv x 5.5x10-2 Kodak 9000 effective dose* * ICRP 2007 calculation Average of 5 units: Sirona - Orthophos XG, Planmeca - ProMax, Kodak - 9000, SCANORA 3D, Instrumentarium - OP 200 VT 13

Variable FOV units ex: Kodak 9300 7 FOVs + pan Voxel size 90-500 µ Scan time 12-28 sec Effective Dose Comparison of Carestream CS 9300 1 Cone Beam CT (CBCT) and Multi-Slice CT (MSCT) 2,3,4 Systems Carestream CS 9300 (CBCT) 1 and Multi-Slice CT (MSCT) 2,3,4 Effective Dose Comparison Sinus 25x12 cm Temporal 25x8 cm Sinus 25x12 cm Temporal 25x8 cm Sinus 17x13.5 cm Head 17x13.5 cm Sinus 17x11 cm Jaw 10x10 cm Temporal 17x6 cm Posterior maxillary 5x5 cm Temporal 5x5 cm TMJ 8x8 cm Full panoramic Standard MSCT Low-Dose MSCT CS 9300 CBCT 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 msv 1 Ludlow JB. Effective doses of CS 9300 cone beam CT system conducted in June 2011. ICRP 2007 tissue weights used. Absorbed dose calculated for bone marrow, thyroid, esophagus, skin, bone surface, salivary glands, brain, lymphatic nodes, extrathoracic airway, muscle, oral mucosa. 2 Faccioli et al. Radiation dose saving through the use of cone beam CT in hearing impaired patients. Radiol Med. 114: 1308-1319, 2009. 3 Niu et al. Radiation dose to the lens using different temporal bone CT scanning protocols. AJNR 31: 226-229, 2010. 4 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. 106: 106-114, 2008. 14

Panoramic Replacement? CBCT is inferior to conventional panoramic imaging for Caries interpretation False positive diagnoses Radiation dose Periodontal assessment CBCT detector Metal artifact effects Some CBCT units have a conventional panoramic option Panoramic detector Kodak 9000 3D Conventional pan vs. CT panoramic layer conventional 20 mm 10 mm 15

Affect of layer thickness on CT panoramic image 5 mm 20 mm Effective dose distribution in maxillofacial imaging 40% of total E dose is from bone marrow & thyroid exposure 55% of total E dose is from salivary gland and remainder exposure 16

Effect of Field of View on dose distribution Dose proportion decreases with decreasing FOV Dose proportion increases with decreasing FOV Example of use of field restriction to reduce dose Orthophos XG 3D 17

Other dose associated technical factors Pulsed x-ray source Scintillator coating Cesium Iodide Gadolinium Oxy-bromide Detector design Image intensifier / Sphere Flat panel / Cylinder Resolution? Spatial Resolution and Dose NewTom VGi 0.3 vs 0.15 voxel size 8 cm x 8 cm Standard Resolution High Resolution 8 cm x 12 cm 0 50 100 150 200 250 2007 ICRP Effective Dose in µsv Average of 70% reduction in dose from use of the standard resolution option 18

Additional dose associated technical factors kvp Added filtration Kodak 9500 3D Effect of added filtration and increased kv Effective dose ICRP 2007 µsv Large FOV (18 x 21 cm) pre-production configuration added filtration configuration Small adult 93 % reduction in dose Medium adult 282 163 42% Large adult 339 260 23% Medium FOV (9 x 15 cm) Small adult 171 76 56% Medium adult 200 98 51% Large adult 166 avg reduction 43% 19

The most significant dose associated factor patient selection criteria ADA/FDA Selection Criteria THE SELECTION OF PATIENTS FOR DENTAL RADIOGRAPHIC EXAMINATIONS Originally developed 1987 Most recently revised 2004 http://www.ada.org/prof/resources/topics/ topics_radiography_examinations.pdf 20

USE OF CONE-BEAM COMPUTED TOMOGRAPHY IN ENDODONTICS Joint Position Statement of the American Association of Endodontists and the American Academy of Oral and Maxillofacial Radiology What patients are most likely to benefit? Difficult diagnosis Equivocal signs / symptoms Superimposed structure Internal / external resorbtion Unusual morphology Root or canal numbers Root curvature Intraoperative complication Refractory to conventional treatment Pre-surgical Proximity and relationship to nerve canal or sinus Pathology of non-endodontic origin suspected Joint Position Statement of the American Association of Orthodontists and the American Academy of Oral and Maxillofacial Radiology THE USE OF RADIOLOGY RADIOGRAPHIC EXAMINATIONS IN ORTHODONTICS currently under development children may be two to ten times or more sensitive to radiation carcinogenesis than mature adults* *Smith-Bindman R, et al. Radiation dose associated with common computed tomography examinations and the associated lifetime attributable risk of cancer. Arch Intern Med. 2009 21

Risk differences due to age Children may be 2 to 10 times more sensitive to radiation than adults Brenner D. 2007 NEJM Risk vs Benefit RISK Risks Dollars Dose ALARA Benefits? 22

Explaining Risk to patients Do Provide an estimate of cancer risk (this should be adjusted for children) Compare with Ubiquitous Background Dose Compare with alternative exam equivalence (pan or FMX) Compare with Commonly encountered risks of life Don t Say it s nothing, it s unimportant, or similar dismissive statements. Use analogy of a day at the beach Comparable Risk Table Situation of a one in million risk of dying Risk Quantity Nature Life Living in stone building 2 Months Natural Radioactivity Living in Denver, CO 2 weeks Cosmic Radiation Travel Canoe 6 minutes Accident Bicycle 10 miles Accident Car 300 miles Accident Airplane 1000 miles Accident Airplane 6000 miles Cosmic Radiation Work Typical Factory 10 days Accident Miscellaneous Smoking 1.4 cigarettes Cardiovascular Disease, Cancer Wine 500 cc Cirrhosis 23

Explaining Benefit to the patients and parents Accurate diagnosis = Reduced cost reduced time reduced discomfort Better outcomes Fewer complications Risk Example The effective dose from a Kodak 9000 medium adult panoramic scan is about 15 µsv The effective dose from average Kodak 9000 4 x 5 cm jaw sextant is about 21 µsv This dose from these combined examinations is equivalent to about 4 days of average naturally occurring background dose The added risk of cancer from this dose is about 2 in 1,000,000 exposures. Keep in mind the population risk of lifetime fatal cancer is 1 in 5. 24

In accordance with the AGD, I declare that I have received expense reimbursement and honoraria from Carestream Dental for dosimetry studies performed on Carestream CBCT units discussed in this presentation and have received expense reimbursement and an honorarium for this talk. Course Code 4440-031115-58 1 - CE unit Presentation slides available at: http://www.unc.edu/~jbl Approved PACE Program Provider FAGD/MAGD Credit 5/31/2010 to 5/31/2012 25