Introduction
The objective of this 2-arm parallel trial was to investigate the recall and comprehension of the information of orthodontic patients undergoing fixed orthodontic treatment using either the verbal explanation supported with the British Orthodontic Society (BOS) leaflet or 3-dimensional (3D) animated content.
Methods
Patients aged 12-18 years, with no relevant medical history or learning and reading difficulties, who were to undergo orthodontic treatment, were randomized to receive information about fixed orthodontic treatment, using either verbal explanation supported with the BOS leaflet or 3D animated content on the basis of the BOS leaflet. Randomization was performed by block randomization; block size of 4 was used, from which 6 blocks with 6 different sequences (AABB, ABBA, ABAB, BBAA, BAAB, BABA). The blinded author asked patients a series of open-ended questions. The primary outcome measure was the total score of the questions. An independent 2 sample t test was conducted to determine if there was a statistical difference in total questions score between the conventional method (verbal and leaflet) and the 3D animation at the time of consent taking (T0) and again 1 year later (T1). The secondary outcome measure was the time spent by the clinician delivering the information to the patient.
Results
Thirty-two patients were randomized into each group. After 1 year, 1 patient was lost in each group. At the time of consent, the conventional group scored 79.1 ± 18.4 compared with 76.4 ± 12.8 for the 3D animation group with no statistically significant difference (95% confidence interval, −11.0 to 5.3), ( P = 0.492). One year later, again, there was no statistically significant difference ( P = 0.639) between the conventional group (75.6 ± 12.3) and the 3D animation group (74.4 ± 9.0) (95% confidence interval, −7.0 to 4.4). The average exposure time to the educational intervention in the conventional group was 8.5 minutes more than the 3D animation group.
Conclusions
The use of 3D animation or verbal and leaflet information is relatively equivalent in transferring knowledge to the orthodontic patient. The use of a 3D animated video reduces the clinician time needed in the clinic to deliver information to the patients and also allows multiple views and better suits the younger generation. Patients undergoing short- or long-term orthodontic treatment do not recall root damage as a risk of orthodontic treatment, which requires special attention from the orthodontist to reinforce this information.
Registration
This trial was not registered.
Protocol
The protocol was not published before trial commencement.
Highlights
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3-dimensional animation is as effective as the written plus verbal in transferring knowledge.
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The use of a 3-dimensional animated video reduces clinical chairside time.
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Patients do not recall the risk of root resorption during orthodontic treatment.
Provision of information is an everyday part of orthodontic treatment; however, little is known on how much information is understood and retained by patients. It is the orthodontists’ responsibility to inform and motivate patients to ensure that they understand the treatment options available and the consequences of orthodontic treatment. Improved communication is associated with greater patient satisfaction, increased compliance, reduced anxiety, and improved treatment outcome. As a result, this may lead to reduced treatment time and improved treatment outcomes. Furthermore, well-informed patients are believed to have more realistic expectations after treatment and are less likely to file lawsuits for malpractice. The value of delivering information in a manner that promotes the above is of particular importance in orthodontics. This is because orthodontic treatment is different from other dental specialties in that the treatment can extend over a protracted-time period (ie, 12-36 months), involving multiple appointments. In addition, treatment is extremely reliant on the patient’s cooperation, in particular with appliance wear, elastic wear, and maintenance of good oral hygiene.
Various studies have evaluated the patients’ comprehension of information given to them before starting orthodontic treatment. , Thomson et al found that patients have a poor recall, in the short term (immediately) and long term (after 8 weeks), of certain aspects of orthodontic information. The questionnaire-based research delivered the information in 3 methods: verbal, written, and visual information. The study concluded that verbal information should be supplemented by written or visual information. Sharma investigated 64 patients with reference to the informed consent process in orthodontics. One group was provided with verbal information alone, whereas the other was provided with verbal and written information. The authors also concluded that verbal information should be supplemented by written information. The evidence would suggest that verbal information should not be given in isolation but supplemented with written material.
Written material, in the form of books and leaflets, is gradually being replaced with digital material. In medicine, the use of animation-assisted informed videos has been reported in several studies. Hong et al compared the use of an animation-assisted informed consent video with standard verbal instructions to explain the use of contrast-enhanced computed tomography. The study reported that animation-assisted informed consent resulted in a greater degree of understanding and satisfaction compared with a standard verbal informed consent. Children with a chronic medical disease, who had access to computer-based patient information, were more likely to change their health care behavior and outcome because of improved knowledge and communication.
Specific objectives or hypotheses
In this study, a 3-dimensional (3D) animation video was developed on the basis of the British Orthodontic Society (BOS) instruction leaflet, explaining the risks and benefits of treatment to patients who were about to undergo orthodontic treatment. The aim was to investigate the recall and comprehension of information among Jordanian orthodontic patients undergoing fixed orthodontic treatment, using either a BOS leaflet supported with a verbal explanation or 3D animated video content. This study is novel in terms of the 1-year recall and the use of a tailored 3D animated video to provide orthodontic information.
The null hypothesis was that there was no statistical difference in total questionnaire score between the conventional method (BOS leaflet and verbal) and the 3D animated video method, for explaining orthodontic risks and benefits, at the time of consent taking (T0) and again 1 year later (T1).
Methods
Trial design and any changes after trial commencement
This study was a parallel-group, randomized, active-controlled trial with a 1:1 allocation ratio. There were no changes to the study design after the commencement of the study.
Ethical approval
Ethical approval for this study was obtained from the Institutional Review Board at the Jordan University Hospital.
Participants, eligibility criteria, and setting
The targeted sample inclusion criteria were as follows: (1) new patients seeking orthodontic treatment at Jordan University Hospital, (2) patients aged between 12 and 18 years, (3) patients were medically fit with no relevant medical history, (4) patients attended regular classes at school with no learning or reading difficulties, (5) no history of orthodontic treatment by the patient or within the family, (6) the native language of the patient and the parent was Arabic, (7) patients and parents had not received any previous orthodontic literature, and (8) the parents approved and consented to participation.
Intervention
The information contained within the Orthodontic Treatment Patient Information Leaflet from the BOS was translated into the author’s first language by the author himself. During the translation, the conceptual differences between the United Kingdom and the author’s country were addressed, as the author had lived in both countries. The same content was used to create an interactive 3D animated video with the help of a professional digital animator ( Fig 1 ). When necessary, the content of the leaflet and the 3D animated video was discussed with a senior academic based in the United Kingdom to ensure no important information was lost during translation.
Patients who attended the new patient clinic to start orthodontic treatment were recruited in this study. In total, 64 patients were recruited into the study; 32 patients were enrolled into the conventional method group, and 32 patients into the 3D animation group ( Fig 2 ). After finishing the treatment planning session and before bonding the braces, patients allocated into the conventional written material group were given the translated BOS leaflet to read in a quiet room for 10 minutes, followed by verbal explanation, in a standardized manner, given by a qualified dentist. On each occasion, the exposure time for the educational intervention, the time needed by the dentist to explain the leaflet, excluding patients’ questions, was measured. The qualified dentist started the timer once she started explaining the leaflet and stopped it when she finished. It was only after this time that patients were given the opportunity to ask questions. Those in the 3D animation group were taken to the same quiet room with standardized lighting and provided with a tablet (Samsung T533, Galaxy Tab4 10.1 Wi-Fi; Samsung Electronics Co, Suwon, South Korea) and headphones (Beats EP on-ear headphones; Apple, Cupertino, Calif) to display the 3D animated patient information. The exposure time for the educational intervention was not measured in this group, as, by definition, it is 0 minutes. Patients are allowed to ask questions after watching the video.
Using the Patient Information Leaflet from BOS, which is the source of information for both groups, 13 open-ended questions with a 25-bullet answer sheet were created ( Supplementary Table ). The first author interviewed the participants in both intervention groups immediately after they finished the intervention. The score was calculated on the basis of the number of correctly answered questions. An answer sheet with a maximum score of 25 was used to record the correct or incorrect answers.
After 1 year, the qualified dentist made a phone call to the participant and organized an appointment with the first author to interview the patients and ask the same questions again and score the patient out of 25, as done in the first interview.
Outcome measures and any changes after trial commencement
The primary outcome measure for this study was the information each individual could recall on the basis of the score calculated out of 25 when the patients answered the 13 open-ended questions. There were no changes to the outcome measures after trial commencement.
The secondary outcome measure was the time taken to deliver the educational intervention. This was defined as the time spent with the patient explaining the information but excluding the patients’ questions.
Sample size
Using G∗Power software (Heinrich Heine University Düsseldorf, Düsseldorf, Germany), on the basis of a significance level of 0.05 and a power for 0.80, a mean difference of 10 points and a standard deviation difference between the 2 groups of 20 points, resulting in moderate effect size, the sample size for the study was calculated as 32 subjects per group.
Interim analysis and stopping guideline
Not applicable.
Randomization
The patients were randomly allocated into group A (conventional written material) and group B (3D animation) using block randomization. A block size of 4 was used, from which 6 blocks with 6 different sequences (AABB, ABBA, ABAB, BBAA, BAAB, BABA) were further created. These blocks were repeated until a total of 50 blocks with a size of 4 each was generated, giving a list of 200 in total. Each block was written on a single square of small-sized paper, folded to hide the sequence, and placed in a jar. A volunteer randomly selected a paper square, and the chosen sequence was used in the enrollment of the sample into the assigned groups.
Blinding
The first author, who was blinded to the intervention, interviewed and conducted the questionnaire for all participants immediately and after 1 year. Blinding of the patients was not possible.
Statistical analysis
The data were inspected for normality using the Pearson coefficient of skewness, which showed a skewness of 0.02, indicating that the data were normally distributed. Additional examination for normality was performed using the Levene test for equality of variance after a t test, and the results showed a nonsignificant variation between examined groups ( P = 0.06). An independent 2 sample t test was conducted to determine if there was a statistical difference in total questionnaire score between the conventional method (leaflet and verbal) and the 3D animation at T0 and T1.
Results
Participant flow
A total of 64 patients were randomized with a 1:1 ratio into either the conventional or 3D animation group. A year later, 1 patient in each group was lost. The reasons for the dropouts were that 1 individual had left Jordan for educational reasons, and the other had been lost to follow-up and could not be contacted ( Fig 2 ). Patients’ recruitment commenced in June 2016 and finished in February 2017. After 1 year, in June 2017, the patients were called for recall assessment and finished in February 2018.
Baseline data
At baseline, information regarding age, sex, monthly income of the family, and educational level of the parents were collected. Baseline characteristics were similar in both groups ( Table I ).
