An occasionally irregular blog about orthodontics

Lets talk about Acceledent….

Lets talk about Acceledent….

Let’s talk about Acceledent….

This is the first post in a new series of posts in which I will discuss old and new developments in orthodontics, that some  may consider to be controversial.  I thought that I should start with Acceledent. For those who are not aware of this new technology, this is an intra oral device that applies vibration for 20 minutes a day to the teeth of patients who are having orthodontic treatment.  The aim of Acceledent is to increase the speed of orthodontic treatment and reduce discomfort.

A large amount of information to both patients and dentists is provided on the Acceledent website. The effects of Acceledent are clearly stated on the front page as

“Through the use of gentle mini pulses, called SoftPulse technology, bone remodelling is accelerated, allowing teeth to move up to 50% faster”.

“Faster tooth movement may decrease the duration of your orthodontic treatment and may help make your orthodontics more comfortable”.

I feel that it is interesting that these are rather cautious, for example “up to 50% faster”.  This is similar to my Broadband contract with British Telecom that is advertised as “up to 76Mb” but in reality I get about 30Mb!

medium_Acceledent_1Lets have a look at the evidence

Acceledent, to their credit, have been very helpful and they have provided a large amount of information on their website. This is in several main sections and I shall start with the case reports on labial orthodontics studies.  There are three case reports that are presented by orthodontic “Key Opinion Leaders” .

For each case the pre-treatment estimated treatment time is presented along with photographs of the treatment and the actual treatment time with Acceledent. These are nicely presented case reports, however, as I have previously discussed in other posts, this is not a strong level of evidence.  But they are interesting.

There is another section on scientific evidence. In this section they listed 6 papers describing animal studies. These were concerned with the effect of vibrations on both tooth movement and sutural growth.  I am no “scientist” but I think that they provided useful information. They also emphasised to me that if I were a dog or mouse and I was fitted with a brace, I was not going to be long on this earth, as I was going to be sacrificed in the name of orthodontics!

The final section was on clinical evidence and I was much more interested in this.  So I had a really good look.  Importantly, these papers were not from the orthodontic scientific literature but were published in “professional dental magazines”, for example, Aesthetic Dentistry Today. These were a mixture of expert opinion and single case reports. Again a low level of evidence.

They had, however, included a paper on a randomised controlled trial carried out at the University of Texas. So I decided to have a really close look at this.

What did they do?

They aimed to evaluate whether the use of Acceledent increased the rate of tooth movement.

They enrolled 45 patients (age range 12.4-40.6 years old) who required orthodontic treatment and the extraction of first bicuspids. They were randomly allocated to an active Acceledent device or to a sham Acceledent device. Each patient was followed until only 1mm of extraction space remained to be closed.

Screen Shot 2015-01-25 at 15.15.54Each canine tooth was retracted by sliding mechanics along 018 ss wires. It appears that in every case the anchorage was reinforced by a TAD. At each four weekly visit the distance between the distal bracket of the canine and the TAD was measured with a digital caliper.

 

What did they find?

They presented data for 39 patients, 21 in the Acceledent and 18 in the control groups.  They analysed the data using simple univariate statistics and I would have liked to see a multi-variate analysis that could have considered the effect of confounders, such as gender, initial position of the teeth and age.  They presented data on alignment from a sub-sample of 14 patients. This number is too low for any meaningful comparison, so I concentrated on the amount of distal tooth movement of the canines.

I have included a table of the relevant data here.

The effect of Acceledent on tooth movement (mm/wk)

 AcceledentShamDifference
Number2118
Mean0.290.210.08
SD0.130.130.24
95% CI(0.23-0.35)(0.15-0.27)(-0.006-0.16)

In the paper they presented  the SE of the means and I have converted this to the standard deviation and then calculated the 95% CI. These figures may not be 100% accurate as I did not have access to their raw data and I just used the information from the website. Nevertheless, this provides an indication of the uncertainty around this data.

This study shows that  the canines in the Acceledent group moved distally on average 0.29mm/week (SD=0.13) and those in the sham group moved 0.21 mm/week (SD=0.12). The 95% Confidence Interval for both groups was 0.06. The mean difference was 0.08mm/wk (95% CI -0.006-0.16). As the confidence intervals and standard deviations are rather wide this means that there is a large amount of uncertainty in this data. This is likely to be caused by the small sample size and natural variation in the rate of tooth movement. Importantly, when we look at the difference between the two groups, the use of Acceledent resulted in a greater amount of tooth movement of only 0.08 mm/week when compared to the sham. I am not convinced that this is clinically significant, even though they reported that it was statistically significant.  They also concluded that this meant a 38% increase in the rate of space closure, but again the distances were very small.

What did I think?

To be honest, it is my academic opinion that this was not a good piece of research for the following reasons.

  1. The age range of the patients was very wide within a small sample.
  2. There was no sample size calculation.
  3. It was not possible to completely blind the measurement.
  4. There was no error analysis of the measurement. This is very important for this study, because of the small amounts of tooth movement that were being measured.  For example,  the error of the method could be greater than the differences between the groups.
  5. They assumed that the position of the TAD did not change. It could have moved because of the vibration?
  6. They only measured one point contact and not bodily movement of the teeth.
  7. There was no mention of the statistical analysis.

I would be very surprised to see this study published in a quality refereed journal.

I have thought about how I would do this study. I would enrol a sample of children with malocclusions and randomly allocate them to “Acceledent” or “no Acceledent” and measure the time that it took to complete their treatment. If we were to measure tooth movement I would measure this from 3D scans.  This would be a challenging study to complete but it would provide us with useful information.

Summary

We all want to make teeth move faster.  I feel that Acceledent  is an interesting concept that is grounded in science. I also wonder if  Acceledent could make teeth move faster along the wires because the vibrations would jiggle the teeth and reduce bracket binding?

However, at present the evidence that supports its use and promotion is currently not at a high level and it would be great to see some well carried out trials.  Nevertheless, it is to Acceledents credit that they are putting forward their claims in a cautious way and using terms such as “may increase the speed of tooth movement”.  Their Key opinion leaders case reports are nicely presented in a great degree of detail.  Unfortunately, some orthodontists websites are not taking the same cautious approach, do a google search and see what is going on……

As I have said before, it is up to us as clinician scientists to interpret the evidence and decide whether or not to use a new development.  Have a look at the evidence in more detail and decide yourselves!

 

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There Are 25 Comments

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  1. Please see our research and data base continues to grow
    http://www.orthopulse.com/doctors/clinical-evidence

    Up to 2/3 reduction in aligner treatment and 50% via conventional bracketing

  2. Craig Dreyer says:

    A clinical vibration investigation was performed in Australia which reported similar results to those presented by the University of Texas study. There was clinically insignificant differences between the test vibration group and similar control group when 10 weeks of alignment was assessed. See Miles et al. Australian Orthodontics Journal, 2012, Volume 28(2): 218-18.

  3. Craig Dreyer says:

    Sorry, the reference should be Australian Orthodontic Journal, 2012, Volume 28(2): 213-18

  4. Jayaram Mailankody says:

    Kevin, It was a nice blog. I agree with your critical analysis of the evidence so far. But compared to other methods of accelerating tooth movement(surgical/drugs), this seems less invasive, and is likely to pass the ethical committee approval easily, for an RCT. Although the initial values of acceleration of tooth movement(in the quoted studies) is marginal, altering the frequency, amplitude and duration of vibrations may help to improve speed and choose optimum therapeutic range. Please note that I do not have any financial interest in the product.

  5. Anthony Puntillo says:

    Kevin, I believe you provided a fair and accurate assessment of the current scientific knowledge on the Acceledent product. I would add one additional point regarding the Texas study. I noticed that in some cases they presented the canines were out of occlusion as bite opening resin was added to posterior teeth. In other cases the canines were left in contact with the opposing dentition. I questioned the author regarding this and was told the resin was added only as needed to achieve treatment goals. However, they did not track which canines were in occlusion and which were out. I would have to believe that occlusal forces either present or not could have an impact on the speed of canine retraction. Therefore, I agree the study does not tell us much. I am interested in the concept. However, before I beginning selling these to my patients at several hundred dollars a pop, I want more science.

  6. Philip Caporusso says:

    The studies presented serve only to validate the sale of a $1000 tooth vibrator. Studies should include a broad range of treatment modalities as well as groups. The marketing gives the feeling that this is a high tech device and those practitioners who don’t utilize the product are missing the boat. Well my patients have an additional $1000 in their pockets.

    • L Nelson says:

      Another thought: Will orthodontist reduce costs of treatment due to speeding up treatment time, resulting in fewer office visits, since there will be less needed? My guess is no way! But I suppose they will justify it by using the same verbiage of “may” and “up to”

  7. Hi Kevin
    I used an Acceledent device to help with my own daughter’s treatment with upper and lower fixed appliances. The experiences were that with school, hockey games, clarinet practice and homework compliance became an issue. She just could not find 20 minutes a day to have the appliance in her mouth! This is with both parents as orthodontists…………………………..
    However, with patients who were less closely linked to me genetically I have had better success and have reduced anticipated treatment times significantly using either fixed or aligner appliances. (self-ligating in case you wonder)
    In conclusion, if a patient is willing enough to pay the premium for an Acceledent device and would like to complete treatment more quickly then it is worth trying. And, I am sure that it is the jiggling effect which is the prime effect.

  8. sarvraj kohli says:

    Very well written article on the purported and self proclaimed advantages by the manufacturers of Accledent. Questionable research and evidence has often been thrust upon doctors at “scientific meetings” by well known renowned Key Opinion Leaders (in some cases sponsored) forcing them to think of every new device as a miracle device.
    And who does it help?
    The patient feels cheated for being asked to pay a higher price for a similar result than what she/he would paid less for by the conventional method. The treating doctor in hindsight feels ‘maybe the device was not as good as it seemed’, and using the phrase “upto 50 times faster” may help the manufacturer get away with it but not the orthodontist.

    • Jared johnson says:

      It is the doctor’s responsibility to critically evaluate this. Before using it on a patient…. I can think of only one reason why someone would do this. It has nothing to do with what’s best for the patient.

  9. Jared johnson says:

    I’m glad to know that at least a few of us in the profession aren’t. selling the snake oil. I wrote this:

    The science behind this is totally lacking. If I am going to sell something to a patient that adds another $1200 on a $5-6000 treatment, I had better be certain that it is effective. Bottom line: the claim that this device can result in an increase in the rate tooth movement by 40% (percent of what?) comes from a few poorly designed studies in which the investigators found a 0.2 millimeter difference between the acceledent group and the non-acceledent group. Regardless of the statistical significance reported, the clinical relevance of LESS THAN a half of a millimeter is negligible. Furthermore there was no standardization of the measurement techniques employed (One of the many problems with the study). From this data the investigators/manufacturer conclude that a 40 to 50 percent increase in the rate of tooth movement with this device is possible. NONSENSE.

    It’s my responsibility as a healthcare practitioner to critically evaluate new techniques, materials, and devices. We should be able to evaluate the quality of the science behind the things we use on our patients. So I see this as a lack of ability, or PERHAPS an abundance of greed. Etheir way, it is unfortunate.

  10. Wouldn’t it be nice if this would work? I think that it would be a revolution. Surely. In fact, if it were so good, we would all be doing it, right? Many questions are still to answer in this debate of accelerating treatments; and I have a feeling it’s only the beginning! Saying to someone: “Your treatment may be up to 50% faster with this appliance” is something that will never be possible to verify. We can always say at the end that it was in fact faster that what it would of been without any acceleration device. But like all these things, from the moment where YOU decide that it’s better with it, from the moment that your PATIENTS decides that it’s better for them, there is certainty that you will both convince yourself that you are right. Human beings are like that: nobody wants to admit they have taken a “bad” decision. Of course there is probably not a big risk of using something like Acceledent. WCS, it does not do anything…. But if the patient thinks it does! Is it better for the patients mind? Will it make it easier for him to go through treatment thinking this device makes it faster and less painful? “Premium non nocere”: using Acceledent probably does not contravene this oath. Let’s hope we will soon see some independent RCT on this… Let’s hope it really works. Keep our minds opened, but let’s make sure we’re not blinded by the light of new revolutions in orthodontics. Sometimes when it’s to good to be true, it is… And sometimes, well, it’s not!

  11. kurt says:

    If you are using invisalign, it does reduce the time by 50% because they tell you to change the trays every week instead of every two. I wonder if it’s safe to move teeth that fast.

    • Jayaram Mailankody says:

      Reply to Kurt: Theoretically, optimum tooth movement is 1mm per month. In view of the fact that aligners move one quarter mm per aligner, that makes four aligners in one month and optimum tooth movement of 1 mm per month. However in practice, there can be many a ‘slips between the cup and the lip’, as the intervals of wear(intermittent),and varied direction and distribution of forces etc.

  12. Adele says:

    I can only comment as an actual user of Acceledent. I’m 58 and am currently on my 21st tray of 37 with Invisalign. I started using Accelelent after the first week. To me it was the way to go considering the fact that it cut the treatment time in half. So far so good!! I change my trays every week and the new trays go on properly( no tracking). I hear so many positive comments of how well they work for others that it couldn’t possibly be a “placebo” effect as some of you seem to claim. My ortho sells them at his cost and as far as I am aware it has been very effective with all of his patients. Just my 2 cents.

    • Yuval says:

      Thanks Adele. To those of us who are not in the profession, but are patients considering the Acceledent, it will be highly interesting to know what did you pay for the device.

  13. Dirk says:

    Even with positive results, at 20% of treatment cost, I’m not sure it’s worth the added expense. My orthodontist sells them at his cost which makes it a more reasonable option. In reality, I think the price point of this applicance should be around $3-400, not whatever retail is, around $11-1200.

  14. Felix says:

    I am 47 user of Invisalign. I started the normal treatment and required 48 trays changing them every two weeks. This equal almost two years of treatment. After one month I decided to used Acceledent because it would reduce the whole process in half (according to my orthodontist) Switching trays every week. It was offered to me for $700 (initially was $1000).
    I am about to end the whole invisalign journey and my teeth look amazing. I am still skeptical about the Acceledent. (would it have been the same without it and changing trays every week? Will never know) But at the end I finished the process in half the time and to me the extra $700 was worth it.
    One thing I noticed, Acceledent reduced the sensitivity of my teeth after switching to a new tray. After a couple of days my teeth were fine.

  15. Carmen R. says:

    I’m 52 and I started Invisalign last April. I went eight weeks without the acceledent as I was skeptical. I decided to try it because I wanted to finish my treatment as quickly as possible and I can say I loved it! I’m close to the end of my treatment now and don’t use it as frequent, but it allowed me to 1). change my retainers every 4 days to a week and 2). Really helped with the discomfort of changing to new retainers. The price of the device seems outrageous, but I’m glad I did it. I had 48 trays and currently waiting to see if I need additional manipulation on the top.

  16. Todd W. says:

    1. The size of the numbers are not important. Is .08 a big number? Or is maybe 5.6 a big number? Well, .08 is huge when compared to .10 (it’s 80%) and 5.6 is tiny when compared to 560 (it’s 1%). The size of a number is only relevant when compared to another number. The point is that 0.29 is 38% bigger than 0.21.
    And 38% is a lot.

    2. I am a mathematician, with a doctorate in quant methods (big deal!). Lots of things in statistics (eg. “statistically significant”) are meaningless horse-feathers and more people are realizing that all the time. The 95% confidence intervals (more horsefeathers?) allow for a difference as big as 0.15 to 0.35, which is a difference of 233%! Again, 38% is a lot. 38% of an 18 month ordeal is nearly 7 months. Seems a good investment to me – IF shortening the time is important to someone.

    3. Perfect analysis is impossible here because the same person cannot do the deal with and than without Acceledent. The statistics say it is quite a difference and the anecdotes I have heard personally and at places like Realself (non-scientific no doubt, but not irrelevant) seem very much in favor (Realself has 89% thumbs up – which is a huge rating there). If you don’t mind the extra 7 months (or so…) then no need to shell out the money. But, to claim there is little evidence to support the efficacy of Acceledent is bad understanding of science, as well as math, and bad critical thinking.

    4. I have never worn braces and do not need them now. I was just researching for a friend. My disinterested conclusion is that there is a good deal of solid evidence to recommend the device – if you feel like 7 months (give or take) is important to you. If it is not, then no point in reading all this, eh? : )

    • Kevin O'Brien says:

      Thanks for the comments. The main issue here is about the effect size in the context of clinical treatment and this is very small, even though you seem to think that it is important. When I looked at this report from the point of view of a clinician, this effect size is so small that I felt that the intervention was not going to make any difference to me or my patients. This is a clear fact of the research and reflects how most medical and dental research is interpreted. I would prefer this interpretation over a website that gathers the opinion of people who have been sold the device….

  17. As mentioned in this blog, acceledents are accelerated orthodontics and are very helpful for faster treatments. But if not used regularly, will not help you benefit from these.

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