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.
They concluded:
“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.
Final comments.
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.
Kudos to Peter Miles and Nikolas Pandis for undertaking and publishing this interesting study. Serving as a fine example to others, it’s both impressive and unusual for individuals outside the hallowed university halls to undertake this type of project. After Lysle Johnston, these authors are part of a rare group who don’t care who is right or who is not, they simply want to know the answer.
Thanks to Dr Miles for this « in house » study. I wish for more like that.
I am not surprised about the results. And I thank you by the way for always bringing back this subject of fastodontics. Of course we would all want and wish and hope for a way to complete our treatment faster. Travelling through time would be nice also. And having a laser saber… Reality is sometimes different. It’s true that compliance is a big part of our reality in orthodontics. I totally agree with you about the smoke and mirror. We like to believe our patients are compliant 100% and that they do exactly as they are told. Reality is probably different. I will always remember that teenager patient I had that was treated with clear aligners. We ended the treatment with a super result (I was satisfied, the patient and the parents were also, this is what I call «super») in less time that was expected (even more «super»). For a case that was not diagnosed as «an easy» case to start. At the last appointment I was congratulating my patient, telling him how good he was and that we could never achieve this kind of success that fast if it would not have been for his excellent cooperation. This is where he started laughing a little. And he asked me: «Can I be honest and tell you the truth?». Who would say «No» to that?
Turns out he was wearing the aligners 15-16 hours/day. No vibration. No MOP. Just… following HIS rule.
I am not saying this would be true for every case. In this case it was. If I would of used vibration with this patient, I would probably say it was the cause of this fast result. The truth is, I have nothing to do with this. I probably planned my treatment well. And all the elements were there at the right time to make it a success. In this case.
I really appreciate this Blog because it really helps me to open my eyes and be more critical about every idea that are supposed to make our life easier. I am more than suspicious when I hear that (insert what you want here) « works all the time » or when I hear a speaker say he never had « any problem ever » with (insert what you want here again!). My answer is always: Maybe you did not do enough!
We all have our clinical opinions and that is ok. But it’s important not to mix it with scientific evidence. Both are important, but they are not the same. I base my decisions and treatment planning on scientific evidence but also on what works well, most of the time, in my hands. But I never did anything that worked all the time. And never did anythig that never failed. I learned the most from speakers who could show what to do when things go wrong. Not « IF » but « WHEN ». And who could tell after explaining: « Ask me how I know! ».
Orthodontic patients often cough up an extra $1000 for this device…hopefully dental authorities will read this and send out notices to their memberships to stop the false advertising and the fraud related to selling devices that do not offer the benefits claimed. This has gone on for years.
Would John Lennon have worn such a device Yar?……Hmmmmmm.
I’m thinking more likely the Beach Boys with their ” good vibrations!”
Hope yer well brutha.
Kevin:
As I have said in my previous responses to this approach, 20 minutes is not gonna cut it. The conclusion might better read “There was no evidence that 20 (twenty) minutes use of AcceleDent Aura influenced the duration of orthodontic treatment or the number of visits”. A priori, it is believed that an orthodontic device needs to be in the mouth for about 8 (eight) Hours to have any clinical effect.
Disclosure: Dr Singh is Founder and Chief Medical Officer, Vivos Therapeutics, Inc.
Thank you Peter Miles and Kevin for highlighting the study.
It is unethical to use a vibration device and make claims about its affect on treatment.
The only positive, is that we know who are unethical and unscientific, and who value financial returns above all else.
While we search for tiny effects of some magic treatment, we should consider the money value of time and the time value of money. Given an evidence-based determination of an effect, we need to consider what a fully-informed patient would be willing to pay, both in time and money. In my research (with Dr. Monisha Gupta Iyer), a fully-informed patient would be willing to pay extra only for effects that are far beyond the proven effects of most things currently for sale in the orthodontic marketplace. World without end.
Well, at least we didn’t name KOL’s this time. A few things. If anybody has done any research on vibration, they know there are two distinct different types of vibration. Low frequency and high frequency. The internal ‘private practice’ studies that have been done and published on high frequency vibration (that apparently are not valid, maybe because they go against this blog’s bias opinion), have shown positive effects much greater than shown in low frequency. I provided these papers in my KOL roast reply. Secondly, I agree that lack of compliance cannot be used as an excuse, but it is a true fact in orthodontic treatment. With low frequency, 20 minutes/day is required. With high frequency, only 5 minutes is required. When I switched from Acceledent (a company actually not even in business at this time as Propel purchased them) to Propel, the compliance of my patients greatly increased and I thus saw a much greater success rate in acceleration.
The second problem though with the study is the ‘blinding’ of the doctor. I understand the intent of this, but this completely flaws the treatments. The whole point of acceleration is to move teeth at a faster rate, thus shortening the appointment intervals, and that is what saves the time. We typically see the patients the same number of times regardless of vibration or no vibration, but we shorten the time between appointments. 14 appointments, every 6 weeks works out to the 20 months shown in this study. 13 appointments, every 6 weeks, works out to the 19 months in this study. The whole point of vibration was lost because the doctor didn’t know what patients to shorten the interval on. Teeth stood still for at least a week every treatment rotation. Had he shortened his interval to 5 weeks, as every vibration using doctor does, he would have then saved 13-14 weeks. At least 3 months. In our practice, we actually shorten our interval by 33%. If the teeth are moving faster, why would you go the same time between appointments? That makes no sense.
Once again, we have worked really hard to find an article that fits our bias on this blog. Yet, we refuse to take the time to review articles provided that contradict this obvious bias.
So, with another attack and arrow shot with this comment “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?” we continue to see the true purpose of this blog. It is not to truly evaluate ALL research out there, but to find the ones that fit the narrative and continue to disparage the work of any KOL.
We are too busy to engage in thoughtful discussion that contradicts bias, but we always have time to find negative research and take pot shots at KOL’s. Surely, it is time for YOU to stop?
Hi Bill, thanks for the comments. I can only write posts on the published literature and I try to confine my posts to trials. Can you point me in the direction of any trial that shows vibration has a positive effect on tooth movement in humans. I may have missed something and I would happily write about it. Thanks: Kevin
Hi Kevin, try this
https://www.dropbox.com/s/cmmabg2lbv6axvn/References%20for%20High%20Frequency%20Vibration.docx?dl=0&fbclid=IwAR1yptrearA0vsnyA3vUItF2Hqnl9FM8H5iEXrKriwYRDSz_v7Ezsc4crho
I would encourage you to reach out to Jonathan Nicozisis through the Orthodontic Pearls Facebook group. He is way smarter than I am (that’s not saying much, I recognize that) and he can have a very educated discussion with you regarding this.
Thank you for reaching out.
Thanks, I will review these in a blog post. Are you happy for me to say that you let me have the list as source material.
Do you want a blog post to state your case about being a KOL? If so just let me know?
Thanks Kevin, appreciate the reply and the offer. Not sure I need to write anything. I think I’ve said my points in your comments section. You may want to reach out to Jonathan Nicozisis. As I said, he is truly brilliant, and his knowledge on the scientific side is much better than mine, I fully and humbly admit that.
Your blog is appreciated all over the world – thank you!