Dr. Brandon Owen on Custom Labial Braces

We consider KLOwen a “100% custom” system. Most of the customization is in the bracket shape and prescription. We use premanufactured brackets with various thicknesses and torques to lower costs and manufacturing time compared to other custom options. There are six bracket shapes for the maxillary incisors, 12 for the mandibular incisors, nine for all canines and premolars, six for all first molars, and eight for all second molars. These 41 bracket shapes produce 6.1 × 1021 different prescription options.

The remainder of the customization happens during bonding. The IDB tray holds each bracket in the precise orientation required for the ideal 1st, 2nd, and 3rd-order prescription for each tooth (Fig. 2). The composite added for the digital IDB process can be up to .1mm thick and provides the final few degrees of torque, if needed. With IDB, the potential prescriptions are virtually infinite, but even with direct bonding, the custom brackets mean that 6.1 × 1021 prescriptions are possible.

DR. KRAVITZ What happens if a patient breaks or loses a bracket?

DR. OWEN If the patient still has the broken bracket, it can be microetched and rebonded. There are two ways to do this: the first is to use a sectioned piece of the original IDB tray, and the second is to directly bond the bracket to the tooth. Using the sectioned tray is better, because the custom composite base can be reapplied. If the original tray is not available, an empty replacement tray can be ordered. Offices using the KLOwen system will have an inventory of all available bracket shapes and torques, so lost brackets can be replaced at the same visit.

DR. KRAVITZ Where are the KLOwen brackets and wires manufactured?

DR. OWEN Most of our brackets are manufactured in the U.S., and currently all of the IDB trays are manufactured at our headquarters in Richardson, Texas. Recently, we have partnered with high-quality manufacturers outside the United States. Wires with our specific bracket-slot dimensions can be ordered through G&H Orthodontics,^*** and we are working to validate other suppliers as well. The precision of the bracket slot and finishing archwires is critical for maximizing the efficiency of all custom fixed appliance systems.

DR. KRAVITZ How is the KLOwen system different from Ormco’s Insignia,^** which was developed in the early 2000s?

DR. OWEN KLOwen and Insignia are vastly different. When Insignia entered the market, it used twin-bracket blanks, and the torque and 1st-order prescriptions were customized by milling the slots. Later, the system changed to a noncustomized solution combining variable torque prescriptions with passive self-ligating brackets. This reduced turnaround time and manufacturing costs but eliminated the customization that had made Insignia unique.

DR. KRAVITZ Does saving three or four visits also reduce treatment time?

DR. OWEN In practice, the average treatment time for comprehensive cases with custom braces can be less than 14 months, and my own average with the KLOwen system is less than a year, but I do not necessarily recommend shortening treatment times as a goal, at least at first. Initially, it makes more sense to keep treatment times relatively similar and instead focus on increasing efficiency and revenue per visit by reducing the number of appointments. After a few years, once doctors master use of the appliances—and address the common patient assumption that the length of the payment plan will match the treatment time—the practice can decide whether it makes sense to shift to shorter treatment times.

DR. KRAVITZ How would you describe the current literature on custom fixed appliances?

DR. OWEN Most of the research on custom appliances has been retrospective.^1-8 All studies have found reduced treatment times with custom appliances. Most also evaluated outcomes, and they found that the ABO Cast-Radiograph Evaluation (ABO CRE) and Peer Assessment Rating (PAR) scores in the custom-appliance group were better than or equal to those in the conventional-bracket group. These types of studies require careful interpretation, because there is judgment involved in determining when a case is finished and the patient is ready to be debonded. I could use an .018" nickel titanium archwire, debond the case a little early to prove my results, and market it as a magic wire.

Clinical research on KLOwen specifically is sparse. Our best data is from our white paper, a 2022 multicenter, retrospective study of 138 patients treated with traditional labial brackets and 269 treated with KLOwen brackets.⁹ (Patients undergoing limited treatment, such as single-arch treatment or simple retreatment, were excluded.) The KLOwen group showed a 31% mean reduction in treatment time and 7.1 fewer office visits. This was a preliminary study, so orthodontists should exercise caution when interpreting the evidence.

DR. KRAVITZ What are some of the challenges a new company faces when conducting prospective clinical studies?

DR. OWEN We have attempted to conduct prospective clinical trials at orthodontic residencies, but we have not had much success, given the difficulty in maintaining stringent research protocols with an ever-changing pool of residents and faculty. You can imagine that this is incredibly frustrating, as years of research and donated products have been wasted. Nevertheless, we will continue pushing for independent prospective clinical trials. We hope to back up our anecdotal claims of increased efficacy with clinical data.

DR. KRAVITZ How can a practice start using the KLOwen system?

DR. OWEN Our team will conduct training sessions to teach the staff how to submit cases. A training team will also hold a virtual session with the orthodontist to provide an introduction to the software and help set up treatment preferences. Next, our clinical trainer will come to the office to assist the team while the first few cases are bonded; we will be by your side throughout the process. For additional information, I encourage orthodontists and their teams to attend lectures or webinars and subscribe to our social-media pages.

DR. KRAVITZ What does the future hold for the KLOwen system?