Ghidurile Europene pentru CBCT - partea I

RADIATION PROTECTION: CONE BEAM CT FOR DENTAL AND MAXILLOFACIAL RADIOLOGY
Evidence based guidelines , a report prepared by the SEDENTEXCT project 2011

www.sedentexct.eu

 

The SEDENTEXCT project (2008-2011) is supported by The Seventh Framework Programme of the European Atomic Energy Community (Euratom) for nuclear research and training activities (2007 to 2011) http://cordis.europa.eu/fp7/euratom/.

Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use that might be made of the following information. The views expressed in this publication/document/guidelines are the sole responsibility of the author and do not necessarily reflect the views of the European Commission.

PREFACE 

SEDENTEXCT was a collaborative project that aimed to acquire key information necessary for sound and scientifically based clinical use of Cone Beam Computed Tomography (CBCT) in dental and maxillofacial imaging. In order that safety and efficacy are assured and enhanced in the “real world”, a parallel aim was to use this information to develop evidence-based guidelines dealing with justification, optimisation and referral criteria for users of dental CBCT. The aim of this document is to provide such evidence-based guidelines to professional groups involved with CBCT in dental and maxillofacial imaging, including:

• Dental and Maxillofacial Radiologists
• Dentists working in primary care and their assistants
• Radiographers/ Imaging technicians
• Medical Physicists
• Equipment manufacturers and suppliers

The core guidance in preparing the document has been from the two relevant Council Directives of the European Union:

• Directive 96/29/Euratom, of 13 May 1996, laying down the basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation (Basic Safety Standards Directive)

• Directive 97/43/Euratom, of 3 June 1997, on health protection of individuals against the dangers of ionising radiation in relation to medical exposure (Medical Exposures Directive).

Beyond these sources, the detailed guidelines have been prepared by systematic review of the currently available literature. No exposure to X-rays can be regarded as completely free of risk, so the use of dental CBCT by practitioners implies a responsibility to ensure appropriate protection. 

This document supersedes the Provisional Guideline document published in May 2009, incorporating new research, including work carried out within the SEDENTEXT project itself. 

Guidelines are not a rigid constraint on clinical practice. Local variations will be required according to national legislation, healthcare provision and practice and the unique clinical circumstances of patients.

I hope that the document will be of help to professional groups and contribute to optimizing the use of ionizing radiation in dental imaging. 

K. HORNER

SEDENTEXCT project Co-ordinator

SEDENTEXCT PROJECT MEMBERS

The SEDENTEXCT consortium is a multidisciplinary team of seven partners, exploiting the synergies between medical physicists, dentists and dental radiologists, dentists, experts in guideline development and industry. In each centre, excluding the industrial partner, there is both dental and medical physics expertise. The Table below lists the participants.

 

Participant	Individuals
University of Manchester, UK	Keith Horner (SEDENTEXCT Project Co-ordinator) Gillian Armitt (SEDENTEXCT Project Manager) Vivian Rushton Hugh Devlin Stephen Birch Anne-Marie Glenny Chrysoula Theodorakou Anne Walker Ian Jacob Katie Howard Lorna Sweetman Mark Worrall Linda Norman Kevin O‟Brien Mohammed Islam Helen McEvoy Gareth Hughes Jim Petch
National and Kapodistrian University of Athens, Greece	Kostas Tsiklakis (Senior scientist) Kety Nicopoulou-Karayianni Harry Stamatakis Anastasia Mitsea Giorgios Manousaridis Konstantina Alexiou Sofia Gavala Konstantinos Merdenisianos Pantelis Karabelas Katerina Donta
“Iuliu Hatieganu” University of Medicine and Pharmacy in Cluj-Napoca, Romania	Mihaela Hedesiu (Senior scientist) Mihaela Baciut Grigore Baciut Horatiu Rotaru Simion Bran Cristian Dinu Bogdan Crisan Sorana Bolboaca Dan Gheban Andreea-Ioana Vicas
Leeds Test Objects Ltd., UK	Mike Bannard (LTO Lead) Adrian Walker Steven Olley Rachel Lamb Pavel Nyvlt
Katholieke Universiteit Leuven, Belgium	Reinhilde Jacobs (Senior scientist) Hilde Bosmans Ria Bogaerts Olivia Nackaerts Ruben Pauwels Bart Vandenberghe Guozhi Zhang Ali Alqerban

 

Katholieke Universiteit Leuven, Belgium (continued)	Maria Eugenia Guerrero Jilke Beinsbergher Pisha Pittayapat
Malmö University, Sweden	Christina Lindh (Senior scientist) Madeleine Rohlin Mats Nilsson Helena Christell Mikael Jurman Maisa Warda Unal Oren
Vilnius University, Lithuania	Deimante Ivanauskaite (Senior scientist) Julius Ziliukas Ausra Urboniene

GUIDELINE DEVELOPMENT PANEL MEMBERS

NAME	CURRENT JOB TITLE	AFFILIATION
Dr Vivian Rushton*	Senior Lecturer/Honorary Consultant in Dental and Maxillofacial Radiology	University of Manchester, UK
Prof. Keith Horner	Professor of Oral and Maxillofacial Imaging/ Honorary Consultant in Dental and Maxillofacial Radiology	University of Manchester, UK
Dr. Anne-Marie Glenny	Senior Lecturer in Evidence Based Oral Health Care	University of Manchester, UK
Mrs. Anne Walker	Consultant Clinical Scientist (Group Leader, Diagnostic Radiology and Radiation Protection)	University of Manchester, UK and North Western Medical Physics, The Christie NHS Foundation Trust
Dr. Chrysoula Theodorakou	Postdoctoral Research Associate	University of Manchester, UK
Prof. Hugh Devlin	Professor of Restorative Dentistry	University of Manchester, UK
Prof. Kevin O‟Brien	Professor of Orthodontics	University of Manchester, UK
Prof. Kostas Tsiklakis	Professor and Chairman of Oral Diagnosis and Radiology	National and Kapodistrian University of Athens, Greece
Prof. Kety Nicopolou- Karayianni	Professor of Oral Diagnosis and Radiology	National and Kapodistrian University of Athens, Greece
Dr. Anastasia Mitsea	Postdoctoral Research Associate Oral Diagnosis and Radiology	National and Kapodistrian University of Athens, Greece
Dr. Harry Stamatakis	Lecturer, Oral Diagnosis and Radiology Department	National and Kapodistrian University of Athens, Greece
Dr. Mihaela Hedesiu	Primary radiology clinician, Head of Dental Radiology department	“Iuliu Hatieganu” University of Medicine and Pharmacy in Cluj- Napoca, Romania
Dr. Horatiu Rotaru	Oral and Maxillofacial Surgeon	“Iuliu Hatieganu” University of Medicine and Pharmacy in Cluj- Napoca, Romania
Dr. Cristian Dinu	Oral and Maxillofacial Surgeon	“Iuliu Hatieganu” University of Medicine and Pharmacy in Cluj- Napoca, Romania
Dr. Bogdan Crisan	Oral and Dentoalveolar Surgeon	“Iuliu Hatieganu” University of Medicine and Pharmacy in Cluj- Napoca, Romania
Dr. Bart Vandenberghe	Dentist and scientific researcher	Katholieke Universiteit Leuven, Belgium
Prof. Ria Bogaerts	Senior Physicist of Personnel Dosimetry and Professor in Health Physics	Katholieke Universiteit Leuven, Belgium
Prof. Hilde Bosmans	Head of the Radiology Physics Group and Professor in Medical Physics	Katholieke Universiteit Leuven, Belgium
Mr Ruben Pauwels	Postgraduate student	Katholieke Universiteit Leuven, Belgium
Prof. Christina Lindh	Professor of Oral and Maxillofacial Radiology and Certified Specialist in Oral and Maxillofacial Radiology	Malmö University, Sweden
Prof. Madeleine Rohlin	Professor of Odontological Diagnostics and Certified Specialist in Oral and Maxillofacial Radiology	Malmö University, Sweden
Ms. Deimante Ivanauskaite	Assistant of Institute of Odontology	Vilnius University, Lithuania
Dr. Gillian Armitt	SEDENTEXCT Project Manager	University of Manchester, UK

 

*Guideline Development Panel Lead

Thanks are also due to the entire SEDENTEXCT Project membership for their contributions and advice on this document.

ACKNOWLEDGMENTS

The SEDENTEXCT project (2008-2011) acknowledges the support of The Seventh Framework Programme of the European Atomic Energy Community (Euratom) for nuclear research and training activities (2007 to 2011).

We thank the following people for their direct assistance with the production of these guidelines:

·         Helen McEvoy for library services.

·         Gareth Hughes and Mohammed Islam for website services.

·         Linda Norman for secretarial support.

We also thank the following individuals, external to the SEDENTEXCT project, who kindly agreed to review the drafts of this document and who provided valuable suggestions for improvement:

·         Nicholas Drage

·         Andrew Gulson

·         John Holroyd

·         John B Ludlow

·         Ralf Schulze

·         Stuart C White

FOREWORD

One objective of the SEDENTEXCT project has been to review the current literature on CBCT and to derive useful guidelines that will clarify those clinical situations in which this imaging technique would be found to be beneficial to both the clinician and the patient.

The method chosen was systematic review of the literature. The literature available for formal review was, however, limited in quantity. Because of this, the Guideline Development Panel also reviewed the many case reports/ series and non-systematic reviews available.

Of particular note is the proliferation in dental CBCT equipment manufacturers and models; research evidence for one CBCT machine may not apply to other equipment. As a consequence, caution is needed in generalising research findings. Many of the recommendations made are “Best Practice” rather than carrying any formal evidence grade, based upon the informed judgement of the Guideline Development Panel.

Please remember that the literature reviewed does not take complete account of publications in the three months prior to the development of these guidelines. In a rapidly developing research field such as this, it will be important that these Guidelines are reviewed in the future. This task would probably be most appropriately taken on by the European Academy of Dental and Maxillofacial Radiology, in conjunction with appropriate collaboration with medical physics experts and colleagues in other dental specialties.

Dr. Vivian E Rushton

Senior Lecturer and Honorary Consultant in Dental and Maxillofacial Radiology

The University of Manchester, UK

SEDENTEXCT Work package 1 and Guideline Development Panel Lead

1: INTRODUCTION AND GUIDELINE DEVELOPMENT

1.1 Imaging in dentistry and the dental and maxillofacial specialties

Radiology is essential to dentists for determining the presence and extent of disease in patients for whom a thorough patient history and examination has been performed. It also has roles in treatment planning, monitoring disease progression and in assessing treatment efficacy.

However, an integral part of radiology is exposure of patients and, potentially, clinical staff to X-rays. No exposure to X-rays can be considered completely free of risk, so the use of radiation by dentists is accompanied by a responsibility to ensure appropriate protection. Unlike most medical imaging, dentists use radiology to a relatively greater extent on children and young adults, so the need for judicious use is paramount.

The advent of CBCT has been an enormous advance in dental imaging. It is a type of imaging technology that is entirely new to dentists. All stakeholders have a responsibility to deliver this technology to patients in a responsible way, so that diagnostic value is maximised and radiation doses kept as low as reasonably achievable.

1.2 Guideline development

1.2.1 Aim

The aim of the work was to develop comprehensive, evidence-based guidelines on use of CBCT in dentistry, including referral criteria, quality assurance guidelines and optimisation strategies.

As well as providing recommendations on the use of dental CBCT in clinical practice, the intention was that the guidelines would be used to identify gaps in research. An over-arching research strategy would be developed to encourage the development of subsequent research projects which will be formative in the update of future evidence-based guidelines for the use of dental CBCT.

1.2.2 Methodology

Guideline development panel (“The Panel”)

A multidisciplinary team was formed from the SEDENTEXCT project academic institutions, consisting of nationally and internationally recognised experts, including dentists, dental radiologists, medical physicists and other dental specialists, including oral and maxillofacial surgery, orthodontics, periodontology and restorative dentistry. The Panel membership was derived from colleagues attending the first SEDENTEXCT meeting held in Leuven in January, 2008, and aimed to represent the many specialties that routinely work with dental CBCT. New members were added to the Panel during the course of the project where a gap in expertise was identified. No conflicts of interest were identified for any member of the Panel. 

Guideline development process

The guidelines have been developed following the methods outlined by the Scottish Intercollegiate Guideline Network (SIGN, 2008). For certain questions addressed in the guidelines, however, the SIGN methods were not deemed applicable. Formal consensus methods were used to produce recommendations based on expert opinion where research evidence was lacking.

Provisional guidelines were developed in 2009 (SEDENTEXCT 2009). The guideline development process used in the current “Definitive Guideline” document was amended to take into account changes in methodology and feedback from the Panel.

The overall administration of the guidelines was shared by the SEDENTEXCT Work package 1 Lead and the Project Coordinator in Manchester, UK.

Scope of the guidelines

At the first meeting of the Panel a consensus process was used to identify the scope of the guidelines. The following key topic areas were initially identified:

·         Diagnostic Accuracy Studies

·         Dose and Risk

·         Optimisation

·         Quality standards/assurance

·         Cost/Benefit Analysis

·         CBCT use

Identification of the literature

An initial search of the FDI guideline database (www.fdiworldental.org) the National Guidelines Clearing House (www.guidelines.gov/index.asp) and MEDLINE (OVID) was undertaken to identify existing guidelines. In addition, searches for scientific papers on the identified topic areas were conducted using MEDLINE (OVID). An initial “„scoping search” was undertaken to gain an overview of the volume of literature; identify further questions that may need to be addressed; establish the research methodologies used within each area and also to identify further search terms for refining the search strategy. There were no restrictions with regard to publication status or language of publication.

The Provisional Guidelines were published in 2009. The search used in the development of the provisional guidelines was modified to increase sensitivity. Box 1 shows the final search strategy used for MEDLINE (OVID). The following databases were searched up to October 2010:

MEDLINE (OVID) (1950 onwards)

EMBASE (OVID) (1980 onwards)

Web of Science

Scopus

UK Clinical Research Network

Clinical Trials.gov

Register of Controlled Trials (www.controlled-trials.com)

NICE guidelines (www.nice.org.uk)

FDI World Dental Federation Guidelines (www.fdiworldental.org).

Additional relevant studies published after this date and identified by other means were also included, although no formal searching was conducted after October 2010.

Box 1. Search strategy developed for MEDLINE (OVID) 1. cone beam computed tomography.mp. 2. volumetric radiography.mp. 3. volumetric tomography.mp. 4. digital volumetric tomography.mp. 5. digital volume tomography.mp. 6. Cone-beam.mp. or exp Cone-Beam Computed Tomography/ 7. (volume ct or volumetric ct).mp. 8. (volume computed tomography or volumetric computed tomography).mp. 9. (cbct or qcbct).mp. 10. or/1-9 11. (dental or dentistry).mp. 12. exp dentistry/ 13. (intra-oral or intraoral).mp. [title, original title, abstract, name of substance word, subject heading word] 14. oral surgery.mp. or exp surgery, oral/ 15. endodontics$.mp. or exp endodontics/ 16. orthodontics$.mp. or exp orthodontics/ 17. (periodontic$ or periodontology).mp. or exp periodontics/ 18. exp dental caries/ 19. maxillofacial.mp. 20. or/11-19 21. 10 and 20

 

In addition to the searches for published primary research, national guidelines were also searched for and used as source material (Box 2).

Assessment of relevance

All search results were imported into Endnote (version XI) for coding. The results of the searching were distributed for screening of titles and abstracts. This process was undertaken independently by teams of three members of the Panel. Full articles were retrieved for all articles considered to be potentially relevant to the subject area by one or more of the reviewers.

 

Box 2. National guidelines used as source material Advies van de Hoge Gezondheidsraad nr. 8705. Dentale Cone Beam Computed Tomography. Brussel: Hoge Gezondheidsraad, 2011. www.hgr-css.be 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. Recommendations for the design of X-ray facilities and quality assurance of dental Cone Beam CT (Computed tomography) systems HPA-RPD-065 JR Holroyd and A Walker. Chilton: Health Protection Agency, 2010a. Health Protection Agency. Guidance on the Safe Use of Dental Cone Beam CT (Computed Tomography) Equipment. HPA-CRCE-010. Chilton: Health Protection Agency, 2010b. Leitlinie der DGZMK. Dentale Volumentomographie (DVT) - S1 Empfehlung. Deutsche Zahnärztliche Zeitschrift 64, 2009: 490 - 496. Statens strålevern. Stråleverninfo 8:2010. Krav for bruk av Cone Beam CT ved odontologiske virksomheter. Østerås: Statens strålevern, 2010. Sundhedsstyrelsen. Statens Institut for Strålebeskyttelse. Krav til 3D dental. Herlev: Statens Institut for Strålebeskyttelse, 2009.

 

Data extraction/quality assessment

The full paper copies of each article identified as being relevant (or potentially relevant) for inclusion in the guidelines were assessed independently and in duplicate and coded as into one or more of the following categories:

·         Radiation dose and risk

·         Justification for referral

·         Equipment factors in the reduction of radiation risk to patients

·         Quality standards/assurance

·         Staff protection

·         Economic evaluation

·         CBCT uses*

(*it was noted that much evidence on dental CBCT comes from case-series and case-reports. In order to gain an understanding of how dental CBCT is being used in clinical practice, it was felt important to gather information from these studies and an assessment of them was undertaken by two Panel members using a proforma adapted from Ramulu et al (2005). However, whilst it was thought useful to identify and report these studies for illustrative purposes, no attempt was made to do a comprehensive review of them).

For all papers coded as “Justification for referral”, an assessment sheet was produced based on the relevant SIGN checklist and the QUADAS checklist (Whiting et al 2003). Studies were sub-divided into those that were diagnostic accuracy studies (primary focus), measurement accuracy or observer studies. Studies were also classified according to their clinical application (Box 3).

Box 3. Clinical categories used for papers coded as “Justification for referral” ·         Localised applications of CBCT for the developing dentition ·         Generalized application of CBCT for the developing dentition ·         Dental caries diagnosis ·         Periodontal assessment ·         Assessment of periapical disease ·         Endodontics ·         Dental trauma ·         Exodontia ·         Implant dentistry ·         Bony pathosis ·         Facial trauma ·         Orthognathic surgery ·         Temporomandibular joint

 

For all other areas (apart from CBCT uses) a generic proforma was developed to tabulate the key features of the study and identify any potential weaknesses in study design.

During the assessment of the studies, each paper was coded as to study design and potential risk of bias (high risk of bias (-), moderate risk of bias (+), low risk of bias (++)). This information was used to aid the grading of any recommendations.

Production and grading of recommendations

The results of the assessment process were used to develop evidence tables. These tables were used to develop recommendations and identify gaps in the literature. Where research evidence was insufficient, the expertise of the Panel was used to draw up provisional “Good Practice” recommendations.

The Delphi technique was used to obtain a consensus from members of the European Academy of Dento-Maxillo-Facial Radiology (EADMFR) on the provisional “Good Practice” statements using an online survey technique. The provisional statements were distributed electronically to all members of the aforementioned group, along with the draft guideline document. Participants were asked to grade each statement from 1 to 5 (strongly disagree to strongly agree). Space was provided for additional comments. The responses were collated and analysed. Consensus was achieved after the first survey round.

When producing recommendations consideration was given to:

·         Volume of evidence

·         Applicability of the findings to clinical practice

·         Generalisibility of the results presented to the guideline‟s target population

·         Consistency of the results (highlight any major inconsistencies)

·         Clinical impact (e.g resource implications, balance of risk/benefit) 

 

Each provisional recommendation was linked, where applicable, to the relevant research evidence. It was graded according to an adaptation of the SIGN grading system (Tables 1 and 2).

Table 1.1: Grading systems used for levels of evidence [adapted from Scottish Intercollegiate Guidelines Network (SIGN), 2008].

1++	High quality meta-analyses/systematic reviews of randomised controlled trials (RCTs) or RCTs (including in vitro studies) with a very low risk of bias
1+	Well conducted meta-analyses/systematic review of RCTs, or RCTs (including in vitro studies) with moderate risk of bias
1-	Meta-analyses/ systematic reviews of RCTs, or RCTs (including in vitro studies) with high risk of bias
2++	High quality systematic reviews of case-control or cohort studies; High quality non-randomised trials, case-control or cohort studies with a very low risk of confounding, bias, or chance and high probability that the relationship is causal
2+	Well conducted non-randomised trials, case-control or cohort studies with a moderate risk of confounding, bias or chance and a moderate probability that the relationship is causal
2-	Non-randomised trials, case-control or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal
3	Non-analytic studies, e.g. case series, cross-sectional surveys
4	Expert opinion

 

Table 2: Grading systems used for levels of evidence [adapted from Scottish Intercollegiate Guidelines Network (SIGN), 2008].

Grade
A	At least one meta analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or a systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results
B	A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or extrapolated evidence from studies rated as 1++ or 1+
C	A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or extrapolated evidence from studies rated as 2++
D	Evidence level 3 or 4; or extrapolated evidence from studies rated as 2+
GP	Good Practice (based on clinical expertise of the guideline group and Consensus of stakeholders)

Two additional gradings are used in this document:

·         A grade of “ED” is applied where a statement is directly derived from The Council of the European Union Directive 96/29/Euratom of 13 May 1996 (laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation) or Council Directive 97/43/Euratom of 30 June 1997 (on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure).

·         A grade of “BP” is applied where a statement was identical to, or directly derived from, a “Basic Principle” of use of dental CBCT, as developed by consensus of the European Academy of Dental and Maxillofacial Radiology (see Section 3 of this document). 

1.3 Future guideline review

No set of guidelines is permanent. In the context of a rapidly growing new technology like dental CBCT, the need for review and development is even more important. This is particularly needed for referral criteria. The first formal statement in this document is, therefore, to recommend that the Guidelines are reviewed after a period no longer than five years after its publication.

These Guidelines should be reviewed and renewed using an evidence-based methodology after a period no greater than five years after publication GP

 

1.4 References

Ramulu VG, Levine RB, Hebert RS, Wright SM. Development of a case report review instrument. J Clin Pract 2005; 59: 457-461.

Scottish Intercollegiate Guidelines Network (SIGN). A guideline developers' handbook. Edinburgh: SIGN; Revised Edition January 2008. Report No: 50.

SEDENTEXCT Guideline Development Panel. Radiation Protection: Cone Beam CT for Dental and Maxillofacial Radiology Provisional Guidelines 2009 (v 1.1 May 2009). www.sedentexct.eu

Whiting P, Rutjes AWS, Reitsma JB, Bossuyt PB, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Medical Research Methodology 2003, 3: 25.