OrthoFX announced preliminary results from a retrospective clinical study comparing treatment effectiveness and predictability of its FXClear aligner system with Invisalign. Titled “Treatment Effectiveness of FXClear Aligner: A Comparison Clinical Study,” the preliminary findings demonstrate that FXClear achieved significantly shorter treatment duration, fewer total visits, fewer aligners used and more precise planned-to-final geometric fidelity while maintaining comparable finishing quality in mild-to-moderate malocclusion cases.
The study represents a head-to-head comparison of comprehensive treatment effectiveness parameters across two clear aligner systems in a clinical setting. Conducted across three private orthodontic practices, the analysis evaluated 111 cases (54 FXClear and 57 Invisalign) with comparable baseline malocclusion severity. All cases were treated by the same orthodontist using identical seven-day aligner change protocols.
The preliminary study showed that FXClear cases completed treatment in an average of 17.3 months compared to 23.0 months for Invisalign — a reduction of nearly six months (25 percent). FXClear also required significantly fewer aligners, averaging 49 per case versus 82 for Invisalign (40 percent reduction).
Total visits were reduced as well, with FXClear cases averaging 12.6 visits compared to 15.4, driven by fewer virtual monitoring visits while maintaining comparable in-office visit frequency.
In terms of precision, 3D superimposition analysis demonstrated significantly lower deviation between planned and actual treatment outcomes for FXClear in both arches. Additionally, 39 to 43 percent of FXClear surface points fell within ±0.5 mm tolerance compared to 27 to 28 percent for Invisalign, indicating greater planned-to-final geometric fidelity.
Importantly, modified ABO Objective Grading System scores confirmed comparable finishing quality between both systems.
A clinically significant finding involved treatment predictability. Invisalign cases showed deviations of up to 1.0 mm in mandibular posterior occlusal surfaces, suggesting potential for unwanted posterior open bite. In contrast, FXClear demonstrated deviations of less than 0.5 mm in comparable areas, indicating more consistent outcomes.
For orthodontists, these findings highlight improved practice efficiency through reduced treatment time, fewer aligners and streamlined scheduling — without compromising clinical results. For patients, the data points to a shorter treatment journey with fewer appointments and greater predictability.
The study is ongoing, with a full manuscript currently in preparation for submission to a leading orthodontic journal.
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