Is this the end of Orthodontic Vibration?
AcceleDent is a vibratory device that is supposed to increase the speed of tooth movement. However, several trials report that there is no evidence to suggest that it is effective. This post is about a new study done in a private orthodontic office. Perhaps this is the end of this “intervention”?
I have posted about AcceleDent several times. In these posts, I outlined studies concluding that there is a lack of evidence on the effects of orthodontic vibration. Dental School investigators have done most of these studies. As a result, their findings may not be relevant to the world of orthodontics delivered in offices. Peter Miles, an Australian orthodontist, did this study in his own office. The Australasian Orthodontic Journal published their paper.
AcceleDent Aura does not influence treatment duration or number of visits.
Peter Miles and Nikolas Pandis
Aust Orthod J 2020; 36: 2-8
I could not find a web address for this paper in the Journal.
What did they ask?
They did the study to answer this question:
“Does AcceleDent Aura influence treatment duration, number of visits and number of bond failures”?
What did they do?
They did a single centre randomised controlled trial with a 1:1 allocation. Peter did this study from his private orthodontic clinic in Caloundra, Australia. The PICO was
Participants: Orthodontic patients under 16 years old having comprehensive orthodontic treatment for Class II Malocclusion requiring the extraction of upper premolars.
Intervention: AcceleDent Aura to be used for 20 minutes per day. The appliance also recorded the patient’s compliance.
Comparison: Treatment as usual, with no additional intervention.
Outcomes: The primary outcome was the duration of orthodontic treatment. Secondary outcomes were the number of bond failures and the number of visits.
They did a clear randomisation and concealment using sealed envelopes. A clinical assistant remote from the operator opened the envelopes to reveal the intervention. They blinded the operator to the treatment allocation.
They recorded the compliance data using the Aura appliance for the first 12.5 months of the study.
What did they find?
They randomised 40 participants. 35 completed the trial with 3 dropping out of the control and 2 leaving the AcceleDent groups.
When they looked at compliance, they found that this reduced throughout the study. At the start of the study, it was 77.8%. This reduced to 39% at the end of the 12.5 months evaluation period.
They did a regression analysis, and this showed that there was no evidence that the AcceleDent had an effect on any of the outcomes. The mean duration of treatment with AcceleDent was 19.49 (SD= 3.7) months, and in the control group, it was 20.7 (Sd=2.3) months.
They found that the mean number of visits with AcceleDent was 13.39, and for the control, it was 14.12. Furthermore, they concluded that there was no difference in the number of breakages between the groups.
They pointed out in their discussion that their results were very similar to other studies that have looked at the influence of AcceleDent on the duration of treatment.
“There was no evidence that the use of AcceleDent Aura influenced the duration of orthodontic treatment or the number of visits”.
What did I think?
I thought that this was an excellent small study. I was particularly impressed that it was done in a private orthodontic setting. As a result, the findings have a high degree of generality. It also illustrates that it is possible to carry out orthodontic research in this setting. It is great to see a study done outside the “strange” world of dental schools.
I looked carefully at the methodology. I was particularly interested in the sample size calculation. This is important because they did not find differences between the interventions. They did not include the sample size calculation in the current paper, but they outlined this in a previous report on this study. They based this on change in the arch perimeter. It is essential to point out that this was not the outcome of the present paper. As a result, we may also consider that there is a risk that the current study was not sufficiently powered to detect a significant difference. Nevertheless, when we look at the effect size, this was very small. As a result, I have confidence in the conclusion that orthodontic vibration did not have an effect.
The authors wrote at length in the paper about the low levels of co-operation. While some may use this as an excuse to suggest that the findings are not correct and fuel the pyramid of denial. I do not agree. This is because, in all orthodontic studies, we carry out interventions that require co-operation. We hope for co-operation, but this is not always forthcoming. As a result, we measure the effect of giving a patient an intervention (orthodontic vibration) and asking them to use it. Consequently, it is entirely correct to present the results regardless of co-operation. If anyone disagrees with this, they are using smoke and mirrors to cause confusion.
This is, yet another study showing a lack of evidence to support the claims made for the use of orthodontic vibration. I think that the case is now closed on this intervention. We have now reached the stage where I wonder if it is unethical to promote this form of treatment to our patients? Yet, the Key Opinion Leaders for Propel and AcceleDent are still hard at work spreading the claims. Surely, it is time for them to stop?
Emeritus Professor of Orthodontics, University of Manchester, UK.