|Year : 2019 | Volume
| Issue : 1 | Page : 49-56
Awareness and practice of ethics and guidelines with cone-beam computed tomography prescription in orthodontics
Shahista Parveen1, Uma Kulkarni2, Rohan Mascarenhas3, Roopali Shetty4
1 Reader, Department of Orthodontics and Dentofacial Orthopaedics, Yenepoya Dental College, Yenepoya University, Mangalore, Karnataka, India
2 Professor in Ophthalmology and Faculty, Centre for Ethics, Yenepoya (Deemed to be University), Mangalore, Karnataka, India
3 Prof., Department of Orthodontics and Dentofacial Orthopaedics, Yenepoya Dental College, Yenepoya University, Mangalore, Karnataka, India
4 Orthodontic Resident, Department of Orthodontics and Dentofacial Orthopaedics, Yenepoya Dental College, Yenepoya University, Mangalore, Karnataka, India
|Date of Submission||15-Jul-2018|
|Date of Acceptance||26-Oct-2018|
|Date of Web Publication||04-Feb-2019|
Dr. Shahista Parveen
Department of Orthodontics and Dentofacial Orthopaedics, Yenepoya Dental College, Mangalore, Karnataka
Source of Support: None, Conflict of Interest: None
Aims and Objectives: Cone-beam computed tomography (CBCT) is now being widely used in orthodontic practice. On the one hand, there is an increasing need of CBCT for diagnosis and research, and on the other hand, there is a broad concern for the exposure to radiation. Prescribing CBCT scan requires judicious clinical judgment to maximize the benefits and minimize the harm. The best way to reduce unnecessary ionizing radiation from CBCT is to follow recommended guidelines and ethical principles. This study was undertaken to determine if ethical principles are followed when prescribing CBCT scans. This study also analyzed the awareness of guidelines for the use of CBCT in orthodontics. Materials and Methods: Web-based questionnaire study was carried out to assess awareness and practice of ethics and guidelines for CBCT prescription after approval from the University Ethics Committee. Voluntariness, privacy, and confidentiality were ensured through informed consent. 101 orthodontists and 103 orthodontic residents participated in the survey. Responses were anonymous and were subjected to statistical analysis. Results: The mean scores were as follows (1) principle of autonomy (0.585 ± 0.25), (2) principle of beneficence and nonmaleficence (0.405 ± 0.17), and (3) principle of justice (0.36 ± 0.22). There is no statistical difference for the scores of ethical principles among orthodontists and orthodontic residents (P > 0.05) except for the principle of beneficence and nonmaleficence (P < 0.05). Only 100 respondents (49 orthodontists and 51 Orthodontic residents) were aware of guidelines for the use of CBCT in orthodontics. Conclusion: This study gives an insight into the practice of ethics and guidelines whenever CBCT scan is indicated in orthodontics.
Keywords: Cone-beam computed tomography, ethical principles, guidelines, orthodontics
|How to cite this article:|
Parveen S, Kulkarni U, Mascarenhas R, Shetty R. Awareness and practice of ethics and guidelines with cone-beam computed tomography prescription in orthodontics. J Indian Orthod Soc 2019;53:49-56
|How to cite this URL:|
Parveen S, Kulkarni U, Mascarenhas R, Shetty R. Awareness and practice of ethics and guidelines with cone-beam computed tomography prescription in orthodontics. J Indian Orthod Soc [serial online] 2019 [cited 2019 Feb 21];53:49-56. Available from: http://www.jios.in/text.asp?2019/53/1/49/251542
| Introduction|| |
Cone-beam computed tomography (CBCT) is an advanced radiological diagnostic tool for the maxillofacial region., Since its introduction in 1996, different manufacturers have developed various CBCT models worldwide.,, The use of CBCT in orthodontics extends from locating of impacted tooth to the planning of orthognathic surgeries.,,,,,
Despite its wider application in orthodontics, the following question recurrently arises: Can CBCT be used routinely in orthodontics? Can as low as reasonably achievable (ALARA) principle, still be applied for CBCT prescription. With time ALARA has been modified to as low as diagnostically acceptable (ALADA) principle which assists the clinicians in selecting appropriate field of view (FOV) based on the region of interest (ROI). The dose of CBCT has become a major concern as ionizing radiation is a known carcinogen. Many orthodontic patients are children and young adults, with many years of life left, during which time latent untoward effects of radiation could progress to life-threatening diseases. Hence, it is important for orthodontists to justify CBCT scans for their patients and to limit radiation exposure. Various international professional bodies have recommended guidelines for the use of CBCT in orthodontics.,,,,,, These guidelines recommend the use of CBCT only in selected cases in which conventional radiography fails to reveal sufficient diagnostic information.
Beauchamp and Childress proposed four principles of bioethics, namely autonomy, beneficence, nonmaleficence, and justice. Autonomy has been described as a patient's ability to make treatment choices based on the sufficient information provided by the clinician. Whenever radiographs are required, it is the duty of the orthodontists to provide their patients with justifiable diagnostic options. The risk–benefit analysis should be carried out before prescribing CBCT. Orthodontists should explain to the patients the need for CBCT in diagnosis and treatment planning and choice should be given to the patients for decision-making. Adequate information should be provided to the patients to make them understand the risks associated with radiation. Informed consent must be obtained from every patient before CBCT prescription. When patients are children and adolescents, their assent also be taken along with informed consent from parents/guardian. This study was undertaken to assess if ethical principles are followed when prescribing CBCT. This study also analyzed the awareness of guidelines for the use of CBCT in orthodontics.
| Materials and Methods|| |
The study was conducted after approval from the Yenepoya (Deemed to be University) Ethics Committee (YUEC/2016/179). Sample calculation of the study was based on independent t- test based on proportion at a significance level of 0.05, and a power of 80% with an effect size of 0.1, each group would require minimum of 100 patients. The number of participants in this survey consisted of 101 orthodontists and 103 orthodontic residents.
The questionnaire was validated by four experts consisting of two orthodontists, a maxillofacial radiologist, and an ethicist. Apart from demographic information [Table 1], the tool consisted of 15 questions on awareness and practice of ethical principles [Table 2]. Q4, Q5, Q7, Q8, and Q9 were related to the principle of autonomy; Q1, Q2, Q3, Q6, Q12, and Q13 were related to principle beneficence and nonmaleficence; and Q10 and Q11 were related to the principle of justice. Q14 and Q15 were framed to assess their knowledge on research ethics. Apart from these, two questions (Q16 and Q17) also tested participant's knowledge on CBCT guidelines [Table 3].
|Table 2: Assessment of knowledge and practice of ethics for cone-beam computed tomography prescription among orthodontists and orthodontic residents|
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|Table 3: Assessment of awareness of guidelines for application of cone-beam computed tomography in orthodontics|
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E-mail addresses of orthodontists and orthodontic residents were collected from an open-source repository. Permission to use the e-mail addresses was obtained from the honorary secretary of Indian Orthodontic Society. An E-mail link to an electronic survey consisting of closed-ended questionnaire was sent to the participants. The information sheet contained details of this anonymous survey and with the assurance commitment that all replies would be kept confidential. Completion of the survey was construed as informed consent to participate in the study. Two reminder e-mails were sent at 2-week interval. The questionnaire was sent to 1458 members of orthodontic society out of which 204 (101 orthodontists and 103 orthodontic residents) responded to the survey. Answers were subjected to statistical analysis.
Statistical analyses were performed using the SPSS software (IBM SPSS Statistics for Windows, Version 23.0. IBM Corp, Armonk, NY, USA). Descriptive statistics were used to summarize the data. Independent t-test was performed to check the association between the answers given by orthodontists and orthodontic residents for the assessment of awareness on ethical principles.
| Results|| |
Demographic information showed that none of the participants prescribe CBCT in their routine cases and request only in special cases to enhance diagnostic information [Table 1].
[Table 2] represents participants responses on awareness and practice of ethical principles associated with CBCT prescription. 146 (74.4%) participants considered risk–benefit analysis before prescribing CBCT (Q1). 105 (53.5%) participants were aware of the term ALARA whereas only 57 (28.9%) respondents knew what is ALADA (Q2 and Q3).79 (38.7%) participants replied that whenever CBCT is indicated for diagnosis, they would give choice to the patients after explaining the need for CBCT (Q4). 120 (59.4%) participants would start orthodontic treatment after explaining the risk if the patient refuses to take a CBCT (Q5). 72 (35.8%) participants have adequate knowledge on FOV selection in clinical situation (Q6). 124 (62.6%) participants would provide complete information on CBCT needs and radiation dosage (Q7). 95 (48.2%) participants had adequate knowledge on assent and consent (Q8). 179 (89.5%) participants would take informed consent from parents/guardian in mentally challenged patients (Q9). 139 (69.8%) participants prescribe CBCT in patients with cleft to understand the discrepancy in 3D (Q10). 45 (23%) participants did not like to expose the patients to extra radiation for their personal benefit such as publication (Q11). 85 (42.5%) participants have replied that in orthodontics CBCT images should be interpreted by either radiologist or orthodontist, or 95 (47.5%) of the participants have answered that CBCT should be interpreted by both (Q12). Whenever CBCT had to be read, 73 (36.9%) participants would also look for any incidental findings apart from the area of interest (Q13). 116 (58.3%) participants have replied that all research projects have to be approved by the Institutional Ethics Committee (IEC) even data will be collected retrospectively (Q14). Only 31 (15.7%) participants have replied that IEC should not approve the project where the use of CBCT is not justified (Q15).
Participant's awareness on CBCT guidelines in orthodontics is summarized in [Table 3] (Q16 and Q17). Only 100 (49.01%) respondents were aware of guidelines for the use of CBCT in orthodontics. Only 27 respondents were aware of guidelines issued by the American Association Orthodontists (AAO resolution, role of CBCT in Orthodontics, 26-10H, 2010).
Information on the practice of ethical principles is summarized in [Table 4]. Questions related to each ethical principle were added up, and the mean score was taken. The mean scores of the principle of autonomy, principle of beneficence and nonmaleficence, and principle of justice were 0.585 ± 0.25, 0.405 ± 0.17, and 0.36 ± 0.22, respectively. There is no significant difference between orthodontists and orthodontic residents in practicing principle of autonomy (P < 0.776), principle of justice (P < 0.160), veracity (P < 0.709), and research ethics (P < 0.201) whereas there is a significant difference in practicing principle of beneficence and nonmaleficence (P < 0.06). The mean score of the participant's practice of research ethics was 0.37 ± 0.27.
|Table 4: Assessment of ethical principles when prescribing cone-beam computed tomography|
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| Discussion|| |
From the time of introduction, CBCT has been widely used and many times overused in orthodontics. With time the probable adverse consequences of CBCT became a concern, and stringent guidelines were introduced. This brought into focus, ethical issues involved with the introduction of newer technology, which increases the exposure to radiation. Therefore, while prescribing CBCT along with the technical requirement, the ethical issues need to be assessed as misuse of CBCT may violate some of the existing accepted guidelines such as ALARA and ALADA. Although technological advances occurred rapidly along with increasing number of CBCT machines, full implication in use and overuse is yet to sink in. Therefore, in overall interest of the well-being of the patient, it is necessary that every clinician using CBCT should be aware of the guidelines and ethical principles, along with the technical aspects of this newly introduced technology. This questionnaire was designed incorporating ethical principles and guidelines.
In the present survey, CBCT was not used as a primary diagnostic tool [Table 1]. 78.1% of the respondents use CBCT in <10% of their routine cases. 87.5% of the respondents have prescribed CBCT to enhance diagnosis in selected cases only. Smith et al. surveyed orthodontic residency programs in the United States and Canada to assess current trends of CBCT use. In their study, CBCT was used for specific diagnostic purposes such as localization and identification of impacted canines. Rajadhyksha et al. reported that 85.7% of the respondents prescribed CBCT in their practices. Their study also reported that CBCT was not a primary diagnostic tool for routine cases.
Principle of autonomy
Every individual has the right to make their own decisions regarding their treatment. Autonomy should be respected by allowing patients to make their own informed choices for treatment. On the issue of CBCT, autonomy refers to respect for person's choice of diagnostic modality. The principle of autonomy also includes paternalism, veracity, and informed consent. Opposite of autonomy is paternalism, which limits the patient's liberty. Informed consent should be obtained from every patient before taking CBCT, and the risk associated with stochastic effects of radiation should be disclosed in the information sheet provided to the patients in a simple, understandable manner. In cases where patients do not have the mental capacity to give informed consent, consent can be obtained from parents/guardian. Q4 dealt with respect for the autonomy of a patient. Many times, control over therapeutic and diagnostic choices is no longer the decision of the clinician, but of the patient. If the orthodontist agrees to treat the patient, and the patient accepts the shortcomings of his/her treatment choice, one can treat them under-informed refusal. Informed refusal should be respected and valued just as much as informed consent. In this current study, 120 participants were ready to treat their patients under-informed refusal (Q5). Q7, Q8, and Q9 were framed to assess their knowledge on informed consent during CBCT prescription. Q7 also assessed their attitude toward veracity. Q9 also dealt with paternalism and indicated that very less percentage (2.5%) of orthodontists practice paternalism. In the present survey, about 60% of the participants are practicing the principle of autonomy, veracity, paternalism, and informed consent [Table 2] and [Table 4].
Principle of beneficence and nonmaleficence
The duty of the orthodontist, as per this principle, is to always serve in the best interest of the patients by maximizing benefits and minimizing harm. This principle is very valuable when orthodontists have to weigh the net benefit from the CBCT scan against the radiation risks. Appropriate FOV should be chosen for CBCT prescription based on the ROI. The FOV chosen could be too large, in which case the radiological principle of ALARA is not respected, or the FOV chosen could be too small, thereby missing out any important information. Q1, Q2, Q3, Q6, Q12, and Q13 from [Table 2] were related to the principle of beneficence and nonmaleficence. In the present survey, <50% of the participants' practice principle of beneficence and nonmaleficence. Q12 dealt with the responsibility of interpretation of CBCT scan in orthodontics. Jerrold's article offers a few useful rules. If you take a scan, you should be able to read it. If you cannot reasonably interpret the images yourself, you should refer the patient to a qualified radiologist.
Here, the majority of the clinicians indicated that the scan should be interpreted by both either radiologist/orthodontist [[Table 2], Q12]. Both of these options are clinically justified depending on the situation. It is desirable that both the orthodontist and radiologist should opine so that incidental findings are overlooked.
Principle of justice
The principle of justice compels clinicians to treat their patients in a fair and just manner. The orthodontist should provide their patients with informed and justifiable diagnostic options. Q10 and Q11 were based on the prescription of CBCT in patients with cleft lip and palate (CLP). Various international guidelines justify the use of CBCT in patients with CLP and CBCT is preferred over the use of CT images because of less radiation and low cost. Exposing a patient to posttreatment CBCT for acceptance of paper in journals is not justified. Keeping in mind Sedentex CT guidelines allow for CBCT scan in patients with CLP, where pretreatment CBCT already taken, the clinician should take a decision judiciously for the request of posttreatment scan. In the present survey, <40% of the participant's justify the use of CBCT prescription.
A recent overview of articles in four major orthodontic journals reported that CBCT ranks second in the area of publications. It is unethical to prescribe CBCT for prospective research to produce data for future research projects., Strict regulation should be made for accumulating routine, CBCT imaging and later storing as retrospective database. This would increase the collective effective dose for patients and ultimately may cause harm. Q14 and Q15 were related to research ethics [Table 2]. 58.3% of the clinicians said that all the research projects should be scrutinized by IEC. 17.1% had an opinion that IEC is not required for retrospective data. IEC is required including anonymized data to maintain privacy and confidentiality. It should be noted that the person who maintains data holding under fiduciary capacity and is not authorized to share data. Fidelity is a concept wherein patient trust a doctor for sharing data, and there should not be any violation of fidelity. As CBCT is a new technology, and when there is no existing data, CBCT can be used to assess the changes in 3D. Keeping the adverse consequences of CBCT, such studies should not be repeated.
Cone-beam computed tomography guidelines and protocol
Minimizing harm to patients is a fundamental obligation of all clinicians. Regulatory bodies, professional societies, and individual have made many suggestions, proposed guidelines, and criteria for the use of CBCT.
Farman in 2005 proposed the ALARA principle, which has been subsequently modified to ALADA by Jaju and Jaju in 2015. British Orthodontic Society in 2008 suggested that CBCT should not be used routinely in orthodontics. The European Academy of Dentomaxillofacial Radiology came out with best practices and responsibility for practitioners using CBCT.
Many times, newer technology can be misused due to various reasons including financial and academic considerations. New York Times in 2010 brought to light the abuse of CBCT by orthodontists especially in children and adolescence. In 2010, the AAO adopted a resolution (26-10H, 2010) which states that “there may be clinical situations where CBCT may be of value, however, the use of such technology is not routinely required for orthodontic radiography.”
Gray (2010), Kokich, Turpin, and Halazonetis reiterated that CBCT guidelines should be followed and for any CBCT prescription benefit should outweigh the risk. Nervina recommended that CBCT should be used in cases only when conventional radiographs cannot give satisfactory diagnostic information. In 2013, Greco pointed out that misuse takes place in residency programs in universities and should be used only for academic purposes.
SEDENTEXCT (2008–2011) was a collaborative project by the European atomic community (Euratom), aimed to acquire key information necessary for sound and scientifically based clinical use of CBCT in dental and maxillofacial imaging. These guidelines mandated recording of the justification process for CBCT prescription and a complete interpretation of CBCT should be reported and documented.
In 2011, the first consensus workshop on guidelines for the use of CBCT was organized by the Swiss Association of Dentomaxillofacial Radiology. In orthodontics, CBCT imaging is only justified if the expected additional information is therapeutically relevant compared with conventional orthodontic two-dimensional imaging. In 2013, the American Academy of Oral and Maxillofacial Radiology under the guidance of Farman on the request of the American Association of orthodontists appointed Mansur Ahmed to formulate CBCT guidelines in orthodontics. These guidelines recommended that CBCT should not be used for routine diagnosis and should be prescribed when CBCT can potentially add new information to aid patient management. CBCT may be used in the assessment of impacted teeth, in complex skeletal abnormalities, and in assessment of orofacial cleft.
Applegate and Cost, White et al., Garib et al., and Abdelkarim were of opinion that in order to avoid unnecessary ionizing radiation exposure appropriate selection criteria should be used and prescribing CBCT should be avoided solely for the research purpose. Padmanabhan and Venkateswaran in JIOS editorial suggested that until guidelines are framed in India, CBCT should be used judiciously in situ ations where benefit should outweigh risks.
In the present survey showed that only 100 (49.01%) participants were aware of guidelines.
Although E-mail was sent to 1458 members, only 204 participated in the survey with a response rate of 14%. Hence, the findings of this study are difficult to generalize. Although editorials of many dental journals published CBCT and ethics, till date, no study has been carried out to assess incorporation of ethical principles while prescribing CBCT.,,,,,
| Conclusion|| |
The present study is an insight to ethical principles and guidelines for CBCT prescription in orthodontics which requires judicious clinical judgment to maximize the benefits and minimize the harm. The study concluded that many orthodontists are not aware of guidelines while prescribing CBCT in orthodontics. The participant's awareness and practice toward ethics are moderate. Further studies are required to bring more awareness on ethical principles and guidelines for CBCT prescription.
To avoid the deleterious use of CBCT, it would be appropriate if CBCT guidelines are incorporated into dental education curriculum. It should also be mandatory for all prescribing orthodontists to undergo training/certification in CBCT protocols and guidelines validated by an appropriate regulatory body. Continuing education and training after qualification will also be required to update with newer CBCT machines.
This study was carried out as a project for 'Post graduate Diploma in Clinical Ethics' Center For Ethics, Yenepoya (Deemed to be University).
Financial support and sponsorship
This study is self-supported.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]