Informed consent is an ethical and legal requirement before performing a CBCT scan. This document must explain to the patient — in understandable terms — which procedure will be performed, why it is indicated, what the associated risks are, what benefits are expected, and what reasonable alternatives exist.
Below you will find three variants ready to print or copy into your center's system. Clauses can be adapted to local regulations (radiation protection regulations, the country's data protection law, the deontological code of the relevant professional association).
1. Adult patient variant
Informed consent for CBCT — Adult patient
Imaging center: ___________________________________________
Responsible professional: ______________________________________
Date: ___ / ___ / _______
Patient data
Full name: __________________________________________________
ID document: __________________ Date of birth: ___ / ___ / _______
Phone: ____________________ Email: ________________________________
Referring dentist / Clinical indication
Referring dentist: _______________________________________________
Reason for the study: ___________________________________________________
Anatomical region: _____________________________________________________
Requested FOV: _______________________________________________________
1. Description of the procedure
I declare that it has been explained to me that cone-beam computed tomography (CBCT) is a three-dimensional diagnostic imaging study that uses ionizing radiation (X-rays) to obtain detailed images of the bony and dental structures of the craniofacial complex. The acquisition typically lasts between 10 and 40 seconds, during which the equipment rotates around my head while I remain still.
2. Justification and benefits
I understand that this study is requested to obtain diagnostic information that cannot be obtained with conventional radiographs (panoramic, periapical) and that is necessary to properly plan my treatment. I have been informed that the decision to perform the study is based on the justification principle: the expected diagnostic benefit outweighs the risk associated with radiation exposure.
3. Risks and side effects
I have been informed that the effective dose of a dental CBCT is typically low (between 0.02 and 1 mSv depending on the field of view and equipment parameters), comparable to a few months of natural background radiation. There are no relevant deterministic risks (acute effects) at these doses. The stochastic risk (probability of long-term cancer induction per unit of dose) is very low but not zero, and is minimized by applying the ALARA principle ("As Low As Reasonably Achievable"): the smallest FOV compatible with the clinical question, the equipment's lowest-dose protocols, and leaded shielding elements as appropriate will be used.
4. Alternatives
The available alternatives have been explained where applicable, such as intraoral radiographs, panoramic radiograph, or magnetic resonance imaging (when the case allows). I understand why, in my particular case, CBCT is the most appropriate modality.
5. Data confidentiality
I accept that the images and associated data are stored and kept by the center in accordance with the data protection regulations in force. These data may be shared exclusively with the requesting professional and, where applicable, with other professionals involved in my treatment, through secure means. I have rights of access, rectification, objection, portability, and erasure over my personal data.
6. Revocation of consent
I understand that I may revoke this consent at any time before the study is performed, without need for justification and without affecting my healthcare.
Declaration
I have read this document, had the opportunity to ask questions, and received answers I consider satisfactory. I understand the procedure, its risks and its alternatives, and I freely consent to the study being performed.
_________________________________
Patient signature · Printed name · ID
_________________________________
Professional signature · License number
2. Pediatric patient variant (minor)
Informed consent for CBCT — Pediatric patient
Imaging center: ___________________________________________
Responsible professional: ______________________________________
Date: ___ / ___ / _______
Minor patient data
Minor's name: __________________________________________________
ID document: __________________ Date of birth: ___ / ___ / _______
Age: ___ years
Legal representative data
Full name: __________________________________________________
ID document: ____________________ Relationship: ☐ Mother ☐ Father ☐ Legal guardian
Phone: ____________________ Email: ________________________________
Referring dentist / Clinical indication
Referring dentist: _______________________________________________
Reason for the study: ___________________________________________________
Anatomical region: _____________________________________________________
Requested FOV (reduced FOV recommended in pediatrics): ______________
1. Description of the procedure
I declare that I have received the information that CBCT is a three-dimensional diagnostic study using ionizing radiation. The acquisition usually lasts between 10 and 30 seconds, during which the minor must remain still with the head supported on the equipment. If the minor does not cooperate, the study may be repeated or, in exceptional cases, alternatives may be considered.
2. Specific justification in pediatrics
I understand that in pediatric patients the justification principle is applied with special rigor: CBCT is only performed when the diagnostic benefit is clear and the necessary information cannot be obtained with lower-dose radiographs (panoramic, periapical). The referring dentist has determined that in this case CBCT is the appropriate modality.
3. Particularities of pediatric radiosensitivity
I have been informed that developing tissues (especially thyroid and salivary glands, bone marrow, and lens of the eye) are more radiosensitive in pediatric age than in adults. For this reason, the equipment will be configured with the smallest possible FOV, optimized lower-dose pediatric parameters, and leaded shielding will be used on the neck (thyroid collar) and trunk when indicated. Even so, a low but non-zero stochastic risk remains, similar in magnitude to a few months of natural background radiation.
4. Alternatives
The available alternatives have been explained where applicable (intraoral radiographs, panoramic, magnetic resonance imaging without radiation). I understand why, in this case, CBCT is the most appropriate modality.
5. Confidentiality and rights
I accept that the minor's images and data are stored and kept in accordance with the data protection regulations applicable to minors. As the legal representative, I retain the rights of access, rectification, objection, portability, and erasure over the minor's data.
6. Revocation of consent
I may revoke this consent at any time before the study is performed, without need for justification and without affecting the minor's healthcare.
Declaration of the legal representative
I have read this document, had the opportunity to ask questions, and received satisfactory answers. I understand the procedure, the risks and the alternatives, and I freely consent to the study being performed on the minor I represent.
Minor's assent (if 14 years or older)
I have received information about the study in an understandable manner and I agree to undergo it: ☐ Yes ☐ No
_________________
Representative signature
_________________
Minor's assent (if applicable)
_________________
Professional · License number
3. Pregnant patient variant
Informed consent for CBCT — Pregnant patient
Important: in pregnant patients, CBCT is only performed when the indication is justified and the study cannot be deferred to the postpartum period. If the procedure can be postponed without harm to the treatment, it is deferred.
Imaging center: ___________________________________________
Responsible professional: ______________________________________
Date: ___ / ___ / _______
Patient data
Full name: __________________________________________________
ID document: __________________ Date of birth: ___ / ___ / _______
Weeks of gestation at the time of the study: ____ weeks
Trimester: ☐ First ☐ Second ☐ Third
Phone: ____________________ Email: ________________________________
Referring dentist / Clinical indication
Referring dentist: _______________________________________________
Reason for the study: ___________________________________________________
Justification for not deferring the study to postpartum: ___________________
___________________________________________________________________
1. Description of the procedure and exposed area
I declare that I have received the information that CBCT is a three-dimensional diagnostic study using ionizing radiation. In dental CBCT, the primary beam is directed at the craniofacial complex, a significant distance from the abdomen and pelvis. Direct fetal dose from scattered radiation is very low, generally well below the thresholds associated with deterministic effects (typically less than 0.01 mSv to the fetus, compared with the 100 mSv threshold for demonstrated teratogenic effects).
2. Application of the reinforced ALARA principle
I have been informed that in my case additional radiation protection measures will be applied: use of a leaded abdominal apron, leaded gonadal protection, the smallest necessary FOV, the equipment's lowest available-dose parameters, avoiding repeating the study unless justified, and, when possible, postponing the study to the second or third trimester.
3. Risks to the fetus
I understand that ionizing radiation at high doses can produce effects on the fetus (deterministic effects such as malformations from 100 mSv, stochastic effects such as an increased probability of childhood cancer). The doses received by the fetus in a dental CBCT applying ALARA are several orders of magnitude below these thresholds and are considered very low risk. Nevertheless, the risk is not zero and deferring the study is preferred if the clinical situation allows it.
4. Alternatives evaluated
The alternatives have been explained to me: deferring the study to postpartum (when clinical urgency allows), lower-dose radiographs (panoramic, periapical), or magnetic resonance imaging without radiation. I understand why, in my case, CBCT at this time is the most appropriate option and the benefit justifies the low risk.
5. Data confidentiality
I accept that the images and data are stored and kept in accordance with the data protection regulations in force. I retain the rights of access, rectification, objection, portability, and erasure over my personal data and those of the fetus when applicable.
6. Revocation
I may revoke this consent at any time before the study is performed.
Declaration
I have read this document, had the opportunity to ask questions, and received satisfactory answers. I have been informed of my pregnant condition and of the additional measures that will be applied to protect the fetus. I understand the procedure, the risks and the alternatives, and I freely consent to the study being performed.
_________________________________
Patient signature · Printed name · ID
_________________________________
Professional signature · License number
About these templates
These three variants cover the minimum principles of informed consent in dental imaging using ionizing radiation: identification of the patient and the professional, clinical justification of the study, description of the procedure, associated risks (deterministic and stochastic effects), expected benefits, alternatives, data confidentiality, and a revocation clause.
The effective dose of a dental CBCT typically ranges from 0.02 to 1 mSv depending on FOV, equipment parameters, and protocol. For context: a classic panoramic delivers ~0.01 mSv; annual natural background radiation is ~2.4 mSv; a medical head CT may exceed 2 mSv. Adapt the specific values to your equipment.
In pregnant patients, the reinforced ALARA principle applies: the CBCT indication must be justified and not deferrable. If the study can be postponed to the postpartum period without harm to treatment, it is deferred. When performed, leaded apron and thyroid collar are used, the smallest necessary FOV is chosen, and the clinical justification is documented.
In minors, consent is granted by the legal representative (mother, father, or guardian). For adolescents aged 14 or older, it is recommended to also include the minor's own assent.