Anyone with Knowledge or Experience with Propel Therapy?

[djspeece]

I am currently at month 25 of what was thought to be about a two year therapy. I have no issues with the time extension; I know the times quoted by the ortho are estimates. Things are about done, save my bottom molars that are moving very slowly. I think the glaciers made better time.
At my routine monthly appointment yesterday, the ortho asked about my interest in Propel. I have a lot of research yet to do, but in a nutshell he applies local anesthetic to the gums and then drills in small screws into the jaw, at depths that I believe range from 2 - 5 mm. The screws are then backed out, and this process is repeated from time to time (not sure of the interval). The idea is that this process initiates an inflammatory reaction that facilitates more rapid tooth movement. I am not sure of the physiology behind it, but will find out. If any of you know how inflammation and tooth movement are associated, please share.
I asked him how much longer I would be in braces without it, and he estimates 6 months. In terms of speed, his research and conversations with colleagues indicate that the time in braces can be reduced by something like 60%. So just by the numbers, it might help me avoid 3 or 4 months in additional time.
An important caveat, is that he has not used this before but is impressed by his research and his colleagues who use it. When asked about cost, he was unsure but quoted a price of about $400, maybe more but he had to find out more on that issue. I think I can probably get him to reduce the price if I agree to serve as his poster child for Propel. Normally I am not enthused about being the first patient for some new therapy, but my curiosity was piqued.
What say ye?
I'll have lots of questions for him including
- What are the risks? (in response to my question he specifically indicated that infections were not an issue, which I believe since the hardware does not stay in) I'm more concerned about root reabsorption.
- What are the long term implications in terms of retention?
- How is progress / success assessed?
- How often is the procedure repeated?
- How do you know how far to drill? Where to place the screws?
- Can you share clinical trial data with me and other information from peer-reviewed journals? (and not propaganda from the vendor or sales rep)

Thanks in advance for sharing your knowledge and information. Also, if there are any other questions that you think I should ask I'd appreciate hearing those as well!

[boodles8]

Dan,

I think you're asking good questions. I would add three more.
1) Who paid for the studies? Frequently, studies, even scientific ones, are paid for by the very company who plans to sell the product. It makes sense because they need the study to get FDA approval. I don't consider it reason to throw the study in the trash, but it does raise my level of caution regarding their conclusions. I might dig deeper and see if they ran the proper statistical analyses for the type of data they acquired, and whether they look like they might be covering up negative effects.
2) What affiliations did the authors have? Usually, authors will make a statement about their financial connections somewhere in the article. Double check them if possible. They have been known to be inaccurate/incomplete.
3) Are the studies of good quality? The mere fact of "peer review" does not always mean a study is worthwhile. Your ortho should be familiar enough with research utilization to answer this question for you.

[djspeece]

Dan,

I think you're asking good questions. I would add three more.
1) Who paid for the studies? Frequently, studies, even scientific ones, are paid for by the very company who plans to sell the product. It makes sense because they need the study to get FDA approval. I don't consider it reason to throw the study in the trash, but it does raise my level of caution regarding their conclusions. I might dig deeper and see if they ran the proper statistical analyses for the type of data they acquired, and whether they look like they might be covering up negative effects.
2) What affiliations did the authors have? Usually, authors will make a statement about their financial connections somewhere in the article. Double check them if possible. They have been known to be inaccurate/incomplete.
3) Are the studies of good quality? The mere fact of "peer review" does not always mean a study is worthwhile. Your ortho should be familiar enough with research utilization to answer this question for you.

Excellent points, thanks boodles!

[dantocanada]

I'm having Wilckodontics on my upper arch in December. I think the principal science behind both is the same. It's injuring the bone in order to cause it to go into a "heeling phase" where it becomes more pliable. In my case, I'm doing it as an alternative to SARPE. The fact that it speeds up tooth movement is a bonus.

[sirwired]

Well, I looked up that Propel thing, and could find ZERO peer-reviewed studies on it. (Studies using a particular brand of instrument or appliance always mention that at least somewhere in the study.) Their website is utterly devoid of any information whatsoever other than some bare-bones specifications on the instrument itself (and nothing on the technique.)

Running a clinical trial is expensive, but speaking for myself, nobody's going to be drilling holes in my jaw without some published studies, unless my treatment is part of a proper clinical trial. I found a single press release saying a trial had been done, but could not find the text of the trial itself, peer-reviewed or otherwise.

[djspeece]

Well, I looked up that Propel thing, and could find ZERO peer-reviewed studies on it. (Studies using a particular brand of instrument or appliance always mention that at least somewhere in the study.) Their website is utterly devoid of any information whatsoever other than some bare-bones specifications on the instrument itself (and nothing on the technique.)

Running a clinical trial is expensive, but speaking for myself, nobody's going to be drilling holes in my jaw without some published studies, unless my treatment is part of a proper clinical trial. I found a single press release saying a trial had been done, but could not find the text of the trial itself, peer-reviewed or otherwise.

Thanks, sirwired. I have a friend with access to clinical trial data who is going to do a little research. I do intend to ask the ortho for such studies. The website was fairly useless and I could not find any studies. I may want to start with MEDLINE or something similar.

[Kipepeo]

I am the "friend" Dan speaks of! This Propel device is a Class I exempt medical device. This means it is a low risk device exempt from premarket notification to the FDA, and also means clinical trials are not required. Hard to believe, I know.

The listing on the FDA site is here: http://www.accessdata.fda.gov/scripts/c ... 6&lpcd=EKD

[sirwired]

Even if not legally required, nobody would be drilling holes in my noggin without some concrete evidence it actually does what they say it does.

I'm willing to believe that the risk is low... the device is nothing more than a standard bone drill with a built-in depth limiter, but that doesn't mean it actually has the theraputic benefits they through their third-party proxies. (Note how the actual website for the device carefully doesn't say ANYTHING about what it's good for; a good indication that they simply rely on implying those benefits to doctors, and by extension, patients.)

[newbite]

My ortho mentioned this to me as well . He didn't call it propel, though, he said he would use tad screws (insert and take out). It sounds like the device doesn't matter, it's just the trauma it induces that is desirable to speed bone remodeling via inflammation. Physiologically it's a horrifying idea (I can't even read the word wilkodontics without getting the nails on a chalkboard feeling), BUT if it means better results in significantly less time, well... I would consider the tad screw ~stabbing~ procedure if I were desperate but would never consider wilkodontics. I'm using Acceledent, which is apparently a non-invasive means of speeding bone remodeling via vibration.

[Kipepeo]

I did find information about one study at U of FL. Someone will need to do some digging to find the results, if any.
http://clinicaltrials.gov/ct2/show/NCT0 ... pel&rank=2

But if you do a search on "tooth movement" you get some better hits!
http://clinicaltrials.gov/ct2/results?t ... rch=Search

[djspeece]

I am the "friend" Dan speaks of! This Propel device is a Class I exempt medical device. This means it is a low risk device exempt from premarket notification to the FDA, and also means clinical trials are not required. Hard to believe, I know.

The listing on the FDA site is here: http://www.accessdata.fda.gov/scripts/c ... 6&lpcd=EKD

Thank you Kipepeo! That's very helpful.
I am still waiting to hear from my ortho. I have a regularly scheduled appointment next week, so I'll see what he has to say.

[Bracedforthewedding]

Had the propel procedure done today. It really was not as bad as I thought it would be... I got 3 very small holes all under local anesthetic on my upper right jaw. We will see how I feel tomorrow but I am very optimistic!