Preliminary Findings From a Retrospective Comparison Study Highlight Effectiveness and Clinical Advantages of the FXClear Proprietary Aligner System.
OrthoFX, a leader in innovative clear aligner technology, recently announced preliminary results from a retrospective clinical study comparing the treatment effectiveness and predictability of its FXClear aligner system with the leading clear aligner brand, Invisalign. The study, titled “Treatment Effectiveness of FXClear Aligner: A Comparison Clinical Study,” demonstrates that FXClear achieved significantly shorter treatment duration, fewer total visits, fewer aligners used, and more precise planned-to-final geometric fidelity than Invisalign, while maintaining comparable finishing quality in mild-to-moderate malocclusion cases.
Key Efficiency Findings
The retrospective analysis represents the first head-to-head comparison of comprehensive treatment effectiveness parameters between two clear aligner systems in a clinical setting. The study was conducted across three private orthodontic practices and evaluated 111 cases (54 FXClear cases and 57 Invisalign cases) with comparable baseline malocclusion severity (American Board of Orthodontics Discrepancy Index (DI) scores of 13.20 vs. 14.70; p=.056). Both groups were treated by the same orthodontist using identical 7-day aligner change protocols. The preliminary study revealed:
- Treatment Duration: FXClear cases completed treatment in an average of 17.3 months compared to 23.0 months for Invisalign—a reduction of nearly six months, or 25% (p=.005).
- Fewer Aligners: FXClear cases required an average of 49 aligners versus 82 for Invisalign—a 40% reduction (p<.001).
- Fewer Total Visits: FXClear cases averaged 12.6 visits compared to 15.4 for Invisalign (p=.001), driven by significantly fewer virtual monitoring visits (2.3 vs. 5.5; p<.001). In-office visits remained comparable (p=.533), indicating that efficiency gains stemmed from optimized treatment protocols rather than reduced clinical oversight.
Geometric/Morphometric Comparison
- Greater Treatment Precision: 3D superimposition analysis of planned vs. actual treatment outcomes showed FXClear (n=14) achieved significantly lower deviation (RMS) in both the upper arch (p=.0005) and lower arch (p=.0001), with 39–43% of surface points falling within ±0.5 mm tolerance compared to 27–28% for Invisalign (n=14).
- Comparable Finishing Quality: Modified ABO Objective Grading System scores confirmed that both systems achieved comparable clinical outcomes (n=10 for each group).
Clinical Significance
One of the most clinically significant findings involved treatment predictability. Digital superimposition revealed that Invisalign cases exhibited deviations of up to 1.0 mm in mandibular posterior occlusal surfaces, suggesting possible unwanted posterior open bite—a commonly reported complication. FXClear showed deviations of less than 0.5 mm in comparable areas, indicating more consistent planned-to-final geometric fidelity.
“These findings suggest that FXClear may offer potential efficiency advantages in clear aligner therapy,” the study authors concluded. “In mild-to-moderate complex cases, the FXClear aligner system resulted in fewer total visits, shorter treatment duration, and fewer aligners used compared to the Invisalign aligner system.”
Clinical Implications
For orthodontists, the results highlight a meaningful clinical alternative in the clear aligner market. With 40% fewer aligners per case and nearly six fewer months of treatment time, FXClear offers improved practice efficiency and streamlined scheduling without compromising quality.
For patients, the data points to a shorter treatment journey, fewer appointments, and greater predictability.
Company Commentary
“These preliminary results validate what our clinical partners have been telling us—FXClear delivers a meaningfully different experience for both the orthodontist and the patient,” said Sheila Tan, Chief Commercial Officer at OrthoFX. “Shorter treatment times, fewer aligners, and greater precision aren’t just numbers. They ladder up to happier patients and greater practice efficiency. We’re especially proud that this comparison was conducted under controlled conditions by the same clinician using identical protocols, because it reflects what’s really driving the difference: the proprietary polymer innovation behind our aligner system.”
Tan added, “This study is an important step in demonstrating that FXClear is not simply another aligner alternative; it’s the next generation of aligner innovation and a clinically differentiated system built to raise the standard of care in orthodontics.”
Study Methodology
The retrospective observational study evaluated patients aged 14 and older with mild-to-moderate malocclusion complexity (ABO DI scores between 10 and 30) treated at three private orthodontic practices by the same provider. All patients were treated with nonextraction approaches. Treatment effectiveness was assessed through digital superimposition of initial scans, final intraoral scans, and computerized treatment plan STL files using Geomagic Control X and Meshmixer software. Modified ABO OGS scores were used to grade final outcomes. Statistical analysis employed independent-samples t-tests and Mann–Whitney U tests at p<.05. The full study is ongoing and the manuscript is being prepared for submission to a leading orthodontic journal.
About OrthoFX
OrthoFX was established by pioneers in the clear aligner industry who helped advance and scale leading aligner brands. The founders saw an opportunity to improve predictability and patient compliance by reimagining next-generation polymers, software, and services. The OrthoFX portfolio includes FXClear, featuring stain-resistant material and smooth, scalloped edges; FXBright, a translucent aligner system that offers a naturally whiter appearance from day one; and the AirFlex System with newly announced PrecisionFinish aligners.
For more information about becoming an OrthoFX provider, visit www.orthofx.com.