LightForce makes claims using dodgy evidence?
A few weeks ago, I posted on the LightForce 3D-printed bracket system. The theoretical advantage of LightForce is its custom-made design for each patient, potentially leading to improved efficiency compared to traditional appliances.
In a previous post, I stated that LightForce showed promise as a technological development. However, it was imperative to conduct high-quality research to validate the company’s claims. Regrettably, like many other companies, LightForce made unsupported claims without independent, high-quality research.
Since then LightForce have updated their study. The JCO published this new paper. This is what I think about it.
As you may know, I do not usually write about studies in the JCO, but I feel that I should look at these small pilot studies to explain that we should treat their findings cautiously. Furthermore, I must highlight this form of marketing, even though I know I am beginning to sound like a stuck record.
Clinical Efficiency of LightForce 3D-Printed Custom Brackets in Diverse Practice Settings
Timothy T. Wheeler, Cynthia Garvan, Alexander Waldman, John Ford.
No author declared a conflict of interest.
However, Open Payments data shows that Dr Walkman received $82,000 in 2022 and 2023 from LightForce. Furthermore, in their last paper in the JCO Drs Wheeler and Waldman were listed as shareholders in LightForce.
The study was supported by LightForce.
What did they ask?
They did this study to.
“Find out if a large sample of treated LightForce cases experienced shorter treatment times and fewer appointments than those treated with conventional pre-adjusted appliances”.
What did they do?
They did a retrospective comparison of case series.
They collected the patients from four private orthodontic practices. Specialist orthodontists treated the patients with LightForce or conventional pre-adjusted appliances between August 5th 2019, and July 20 2023.
The inclusion criteria were the availability of pre-treatment photos and the use of fixed appliances.
They collected the patient’s age, Angle classification, extractions, bonding and debonding dates, non-emergency appointments, and information on the final details of the occlusion.
The team also measured case severity by scoring the photographs using the Dental Health Component of the Index of Orthodontic Treatment Need (IOTN).
What did they find?
They collected data on 953 LightForce and 328 conventional bracket patients treated between August 5, 2019, and July 20, 2023. They did not state whether these were the start or finish dates of treatment.
I found the data rather difficult to interpret. This was because they presented it for the individual practices and then for only three practices. The most relevant data I could find was that the mean treatment time for LightForce was 16.4 months, and for the conventional brackets, it was 24.8 months. The mean number of appointments was 9.6 and 14.2 for the LightForce and Conventional Brackets, respectively.
They presented data from only three practices on repositioned brackets and detailing. Unfortunately, they presented this data as box plots, so I could not find the number of procedures, etc.
Their overall conclusions were
“This study demonstrates consistent reductions in treatment duration and the number of appointments needed for treatment with LightForce brackets”.
“Although every attempt was made to eliminate potential sources of bias, a randomised trial would provide a higher level of evidence”!
What did I think?
It was good to see another preliminary study on this innovation. Importantly, this paper was published in the JCO, the relevant journal for a basic case series report. Nevertheless, I was concerned and disappointed that, following its publication, LightForce heavily cited the results of this study in their advertising to patients. For example, their website states that LightForce cases can finish up to 40% faster and links to this paper.
The phrase “up to 40%” is interesting and commonly used in advertising. For example, my broadband provider states that download speeds are up to 500Mbps, but I typically get about 300Mbps. While the statement of “up to” is technically correct, it is also misleading.
The study has significant flaws. The most relevant being the lack of data on the treatment results. They could have used PAR or the ABO discrepancy index to provide this information but didn’t do so because the final study casts were unavailable!
Furthermore, they did not provide relevant data on the pre-treatment severity of the malocclusions. They attempted to do this with IOTN, but unfortunately, this measures treatment need and is a different concept from severity.
As a result, this is similar to a blood pressure study in which the investigators did not measure the initial or even the final blood pressure. They just concluded that the patients took their tablets for a period of time!
Finally, they did the study during the COVID-19 pandemic and lockdowns. It’s uncertain how US lockdowns may have impacted the study. Additionally, we don’t have information about when the conventional bracket treatment was administered. For instance, if they treated most of the conventional cases during the initial stages of COVID-19, the treatment duration might have increased.
Final comments
When LightForce was first introduced, I hoped this company would refrain from making claims based on low-quality research. Currently, these hopes are being dashed in a chase for the market.
The tactic of finding favourable results from low quality studies is not new in marketing drugs. Orthodontic companies have also adopted this tactic, with Ormco citing a low-quality paper. Acceledent relied on a poor trial published in an issue of Seminars in Orthodontics that was rife with conflicts of interest, while MOPS was promoted using data from a poorly reported study.
The disappointing cycle continues.
Wow.. and you are not a stuck record. I thank you for all your time effort and energy and giving us clinical orthodontist information that would allow us to make better decisions based on research!!!
Yes. We’re not easily fooled by companies who do this but I guess we look at the products with an open mind
Overstating efficacy of orthodontic products has become the norm rather than the exception. Invisalign leads the market and others have followed their lead. Thank you for oversight and reporting on this practice. Orthodontists have a responsibility to their patients to not pass along these marketing schemes in their practices.
Based on the nature of the study and the fact that these offices advertised LF, it is very likely that patients that wanted “shorter Tx” took the LF advertising bait, and paid the extra $ to be treated with LF.
Is it outside the realm of possibility to infer that both provider and patient were “incentivized” to finish earlier? After all, the patients paid for “faster”, and upon accepting the fee, the provider was in tacit agreement. That significantly skews the result to favor LF.
The authors conclude that LF was 30% faster, but the authors did not even attempt to measure the quality of the treatment outcome. What did these two groups look like at the end of treatment? Were they finished to the same standards? Why was case complexity not assessed using the ABO Discrepancy Index, and the finished casts and x-rays evaluated using the ABO OGS criteria? After all, they made a point of mentioning that three of the treating clinicians were ABO-certified. We can’t even measure the magnitude of correction of the malocclusions!
Very disappointing that the JCO allowed such a poor paper to be published. One has to wonder who the reviewers were, and if they had conflicts of interest as well.
Thank you Kevin for having the courage to review this against the grain. If these authors are not willing to have the integrity, honesty and transparency to declare their financial interest to the journal, how are we supposed to accept honesty in the methodology and results? It baffles me that authors think they can get away with not declaring their financial interest when they it is publicly available. We saw this in the Invisalign article in the AJODO you reviewed. Lightforce would be a great case study for orthodontic residents, to understands how a company can use marketing and propaganda with social media, backed by pumping of false claims by investor orthodontists and paid KOLs, to make the technology be perceived as more efficient and superior and having orthodontists who don’t use have FOMO through sales reps. We’ve seen this formula before with Damon, accelerant, Invisalign, the list goes on! Perhaps the true secret to orthodontic efficiency is careful diagnosis, treatment planning, execution and understanding biomechanics, but that takes hard work and doesn’t make companies money.
With respect to speeding up treatment everything but the kitchen sink has been thrown at the wall already, with very little results to show for. One can’t help but wonder why the simplest of options is so often disregarded: simply investing more time per appointment.
By not postponing to next time what can be done today, time is saved. Quite often, overly strict time constraints impose severe limitations of what can be accomplished per appointment, thus extending treatment time. The straightforward explanation for the seeming lack of interest would seem to be that investing time this is the least profitable of options: why lower profit by decreasing the number of patients treated per day of profit can be increased by charging extra for questionable appliances or sometimes invasive procedures – or shiny new brackets?
No doubt there have been robust and false claims about efficiency and acceleration of treatment in orthodontics.
I’d love to see more rigorous validation through well designed, randomized clinical trials. While technologies like aligners and custom brackets offer ‘perceived’ benefits of precision and patient comfort, their efficiency needs to be supported by better evidence.
Overstated marketing claims erode trust for vendors. It’s crucial for companies to balance innovation with integrity, ensuring that claims made are backed by independent, (not company funded) research.
We can do better. Let’s go!!
I read with great interest Kevin’s review and appreciate his candor, and ability to get right to the point, KOL’s not being transparent deminishes the integrity of our profession. I also read all of the comments, most validating my comment about KOL’s. Comparing apples to apples by grading cases before and after would be ideal, especially if the study design was prospective rather than retrospective. That alone is the major flaw here. Now, let you give my perspective after using this bracket system, and why I still use it. Or, the better question, why do I continue to use it? (And full disclosure, I am not an investor nor am I under any contract as a KOL with LightForce or any company).
We have been using LightForce since 2019, and have completed close to 200 cases, with more still in active treatment. It is now our most preferred (by patients and staff) digital appliance system for the following reasons, and in no particular order. It is the most delegatable finishing appliance system if your goal is to achieve a board quality result. Although I am an ‘old school’ ABO certified orthodontist (1992) and voluntarily recertified in 2005 using the model grading system, we do not grade every finished case today. I can say anecdotally, this appliance system gets us to the finish line in more consecutively treated cases than any appliance system we’ve ever used. Now, I realize that is a bold statement but this is simply what I’ve observed. Do we finish cases 30-40% faster? In some cases yes, but I doubt it is statistically significant, and likely impossible to measure even in the tightest controlled study. There are simply too many variables. Broken brackets, compliance, oral hygiene, missed appointments still plague our LightForce cases. I do believe again, anecdotally, we will continue to use LightForce because of ease of delegation, best esthetic (ceramic vs metal) fixed bracket and detailed finish. The presence of a ready/backup bracket, in the event of bracket failure, ready to place with the same detailed accuracy, prevents compromised slot positioning.
So is all of this worth 900$+/-? It depends on where you practice and how you want to practice, so I can’t answer for everyone, but it is for me, because it allows me the opportunity to spend less time at the chair, completing tasks that our trained technicians are equipped to do!