Birte Melsen was one of the first to loudly denounce that too many times the orthodontic market as a 10x faster speed rather than clinical research and scientific evidence. Manufacturer’s claim of benefits and orthodontic "miracles" can sometimes enchant the believers, disgust the sceptics and being welcomed more or less warmly by the rest of the orthodontic population. I believe that this is a trait of our profession, and we have to live with it.

Sometimes decades pass before an appliance is clinically tested with a well-conceived study, some of the appliances that we use may not deserve any literature at all. As I have a pretty strong academic background, I like to read well-conceived studies but I also welcome interesting clinical inputs from opinion leaders.

When I approached to the world of customized vestibular braces, some literature was already on the field, and I would like to share the actual evidence about customized brackets

The first paper that we can find is this study published on the JCO with a true Authority (Prof. Bill Proffit), among the authors, who should be supposingly not so biased =).

Clinical effectiveness and efficiency of customized vs. conventional preadjusted bracket systems.

Weber DJ 2nd, Koroluk LD, Phillips C, Nguyen T, Proffit WR.

J Clin Orthod. 2013 Apr;47(4):261-6

In this paper the Authors asked themselves:

1)      Can we get better outcomes with customized braces rather than with standard brackets?

The answer is NO, you get the same results

2)      Can we get faster outcomes with customized braces vs standard directly bonded brackets? In this case the answer is YES, with an average treatment duration respectively of 15 months vs 22 months for cases presenting the same initial situation (assessed with the PAR score). They also reported less appointments: 11 vs 17.

In a later paper by the same group of Chapel Hill (North Carolina, US), the study was widened and opened to patient who also received indirect bonding

Effectiveness and efficiency of a CAD/CAM orthodontic bracket system.

Brown MW, Koroluk L, Ko CC, Zhang K, Chen M, Nguyen T.

Am J Orthod Dentofacial Orthop. 2015 Dec;148(6):1067-74. doi: 10.1016/j.ajodo.2015.07.029.

In this paper the Authors asked themselves exactly the same questions:

1)      Can we get better outcomes with customized braces rather than with standard brackets?

The answer is NO, you get the same results with any of the three alternatives: customized indirectly bonded braces, directly bonded braces, indirectly bonded braces

2)      Can we get faster outcomes with customized braces vs standard directly or indirectly bonded brackets?

The answer was again YES with 14 months of treatment for the Insignia cases vs 18 months for the indirect bonded cases and 22 months for directly bonded. The variation was pretty wide and both indirect bonding technique performed significantly better than direct bonding.

Finally recently a paper, who was also commented by Kevin O’Brien on his blog with a special guest, appeared in the literature as an effort of the Njmegen group (Netherlands)

Orthodontics with Customized versus Noncustomized Appliances: A Randomized Controlled Clinical Trial.

Penning EW, Peerlings RHJ, Govers JDM, Rischen RJ, Zinad K, Bronkhorst EM, Breuning KH, Kuijpers-Jagtman AM.

J Dent Res. 2017 Jul 1:22034517720913. doi: 10.1177/0022034517720913.

This was the only randomized controlled clinical trial that should provide a high degree of evidence.

The questions were again the same and NO, you don’t get any better result with customized braces but they also find that NO, it’s not faster to use customized braces and it adds 85 minutes (85!?!?!) of extra time for managing the setup.

The clinicians were presented as expert of both indirect bonded Insignia and direct bonded Damon system (the two compared treatment regimens). The fact that they reported 85 minutes on average for 90 patients to conceive and approve a good setup make me very suspect on the true expertise of the two clinicians. In my experience it took me 45 minutes to manage the first series of setups for my first cases and it now takes 5 to 15 minutes to achieve a satisfactory setup to be approved thereafter. I won’t define as an expert someone who takes one hour and a half of extra time to adjust a setup. That’s why I have some licit doubts on the outcome of this study.

Evidence based conclusions (for the moment)

• Is Insignia a system to achieve better results?

NO, you can achieve good results even with wooden brackets, if you are a good orthodontist

• Is Insignia a way to get faster (good) results?

YES with caution. The literature disagrees at the moment, but the published evidence goes more on this sense, which is the same feeling that I have clinically.

Personal conclusions (for the moment)

• Is this a strong enough reason to embrace a system of customized braces?

YES, to me it is as I think that to provide a good service in the shortest possible time respecting biology and biomechanics principles and assuring quality outcomes is something that I consider extremely valuable!