This manuscript presents a comprehensive protocol to evaluate the three-dimensional (3D) movement of maxillary posterior teeth with clear aligners using digital model superimposition, an invaluable tool in orthodontics and dentofacial orthopedics.
Since the introduction of Invisalign by Align Technology, Inc. in 1999, questions and debates have persisted regarding the precision of Invisalign (clear aligner) therapy, particularly when compared to the use of traditional fixed appliances. This becomes particularly significant in cases involving anteroposterior, vertical, and transverse corrections, where precise comparisons are of paramount importance. To address these inquiries, this study introduces a meticulously devised protocol, placing a primary emphasis on digitally superimposing the movement of maxillary posterior teeth to facilitate accurate analysis. The sample included 25 patients who had completed their first series of Invisalign (clear) aligners. Four maxillary digital models (pre-treatment, post-treatment, ClinCheck-initial, and final models) were digitally superimposed using the palate rugae and dentitions as stable references. A software combination was used for model superimposition and tooth segmentation. Transformation matrices then expressed the differences between the achieved and predicted tooth positions. Thresholds for clinically relevant differences were at ±0.25 mm for linear displacement and ±2° for rotation. Differences were assessed using Hotelling’s T-squared tests with Bonferroni correction. The mean differences in rotation (2.036° ± 4.217°) and torque (-2.913° ± 3.263°) were significant statistically and clinically, with p-values of 0.023 and 0.0003 respectively. De-rotation of premolars and torque control for all posterior teeth were less predictable. All mean differences for the linear measurements were statistically and clinically insignificant, except that the first molars seemed slightly (0.256 mm) more intruded than their predicted position. The clear aligner system appears to meet its prediction for most translational tooth movements and mesial-distal tipping in maxillary posterior teeth for non-extraction cases with mild to moderate malocclusions.
In 1999, digitally fabricated removable orthodontic appliances were made commercially available by Align (Align Technology Inc., Tempe, AZ). Originally, this system was designed to solve non-growing cases with mild to moderate crowding or close small spaces as an aesthetic alternative to traditional fixed edgewise appliances. With decades of improvements in computer-aided design and manufacturing (CAD/CAM), dental materials, and treatment planning, clear aligner therapy (CAT) has since been used to treat over 10 million patients with various malocclusions worldwide1. A recent retrospective study suggested that CAT is as effective as fixed appliance therapy for the teenage population with mild malocclusions, with significantly improved results in tooth alignment, occlusal relations, and overjet2. The number of appointments, emergency visits, and overall treatment time also had better outcomes for clear aligner therapy patients. Although CAT can be used to treat non-extraction, mild-to-moderate malocclusions in non-growing patients3,4, and shorten treatment duration and chair time5, it remains unclear whether the treatment is as effective as the gold standard of conventional labial braces4,6,7,8,9, especially for anteroposterior and vertical correction10.
ClinCheck is a software platform developed by Align to provide clinicians with virtual three-dimensional (3D) simulations of prospective tooth movements. Primarily concerned with the patient's initial status and the clinician's prescribed treatment plan, it can also be a visual communication tool for the patient. Any mismatch between the predicted and achieved results may require a mid-course correction, refinement, or conversion to fixed appliance therapy. Consequently, the reliability of software predictions has drawn increasing attention from investigators. Since Lagravere and Flores-Mir's systematic review published in 200511, investigations into the concordance between predicted models and post-treatment models have been measured in different ways, measurement methods including arch-length, inter-canine distance, overbite, overjet, midline deviation12, the American Board of Orthodontics objective grading system (ABO-OGS) reduction score13, upper and lower interdental width14, and measures derived from cone-beam computed tomography15.
Comparisons have also been made by superimposing 3D models16,17,18,19,20,21. For example, many current software platforms, such as ToothMeasure (internal software developed by Align Technology), can reproducibly superimpose two digital models using user-selected reference points on untreated teeth, palatal rugae, or dental implants. Since the predicted and achieved models usually do not include the palatal surfaces, many previous studies15,16,17,18 have used the untreated posterior teeth as references for superimposition, including the possibility of adding errors due to the relative movements of these teeth. These studies have been confined to anterior regions of the arch in relatively simple cases with spacing or mild to moderate crowding.
Grünheid et al. used mathematical superimposition to quantify the discrepancies between virtual treatment plans and actual treatment outcomes to evaluate the accuracy of full-dentition CAT without stable anatomic structures in digital models20. Haouili et al. used the same method in a best-fit algorithm within the Compare software to conduct a prospective follow-up study on the efficacy of tooth movement with CAT21. The aim was to provide an update on the accuracy associated with emerging technology, i.e., SmartForce, SmartTrack aligner materials, and digital scans. Their findings of an improved overall accuracy from 41%17 to 50%21 were encouraging but do not negate the possibility that some tooth movements are still not satisfactorily achievable with the clear aligner system.
When predicted and achieved, digital models include a common 3D reference independent of the dentition, such as palatal rugae, dental implants, or tori; they can be co-registered within the coordinate system of many suitable software platforms. If a tooth of interest is then segmented from one and transformed mathematically to match its displaced version in the other, the transformation matrix contains the complete information needed to describe the entire 3D transposition. Its content can be expressed as three translations and three rotations described by a formal convention. An example is found on the Invisalign ClinCheck Pro 3D control software, where the numerical parameters indicating the 3D tooth movements needed to move teeth to their predicted positions are shown in a tooth movement table.
While the initial and final (predicted) models from the planning software share a common coordinate system provided by the same software platform, their absence of palates restricts the possibility of co-registering with any other digital dentition model unless they possess identical dentition. In this context, it was hypothesized that the superimposition of software-predicted and post-treatment (achieved) models would be feasible. This feasibility arises from the availability of two pairs: initial and final (automatically superimposed during export from planning software) and another pair of pre-treatment and achieved models (superimposed using palatal rugae). These pairs could be registered using the pre-treatment dentition as a reference to align them with the Invisalign-initial model. Subsequently, the segmentation of individual teeth could be performed to assess differences in their positions and orientations. This assessment involves transposing teeth between the models, and the transformation matrices would enable a numerical quantification of the translations and re-orientations.
In this protocol, an approach to evaluate the effectiveness of CAT in addressing mild to moderate malocclusions in both adolescents and adults was introduced, specifically focusing on the maxillary posterior teeth. The null hypothesis was that there was no difference between the achieved and the planning software-predicted tooth position in the maxillary posterior teeth after the first series of clear aligners.
This study received ethical approval from the Institutional Review Board at the University of British Columbia (No. H19-00787). To uphold confidentiality, all samples utilized in the study underwent de-identification procedures. Furthermore, prior to their inclusion in the research, informed consent was appropriately obtained from all participating patients.
NOTE: Each participant contributed four maxillary digital models, which encompassed the following:
This protocol leveraged a combination of several software tools, which included CloudCompare, Meshmixer, and Rhinoceros. These software platforms played a pivotal role in facilitating the registration process and enabling the segmentation of individual teeth for the purpose of analyzing their movements and orientations. It is worth noting that these software tools may be replicable with other open-source software options, provided that they can achieve similar objectives. A workflow illustrating the software sequence is presented in Figure 1.
1. Preparation
2. Palatal superimposition of pre- and post-treatment digital models in CloudCompare
3. Software-model preparation for superimposition with Rhinoceros software
4. Superimposition of software-predicted and post-treatment digital models with CloudCompare
5. Crown segmentation using Meshmixer
6. Dental superimposition with CloudCompare
7. Measurement specifications
8. Statistical analysis
A minimum sample size of 24 cases was required to detect an effect change of 0.6° for the average tip and torque angles, with an 80% power and an alpha of 0.0523. The inclusion criteria were as follows: (1) full permanent dentition through the first molars, (2) Class I malocclusions, or less than 2 mm Class II /III malocclusions with spacing, or mild to moderate crowding that had undergone non-extraction Invisalign treatment, (3) completion of the first series of Invisalign aligners at least, and (4) palatal rugae presented on both the initial and refinement intra-oral scans. The exclusion criteria were: (1) previous exposure to auxiliary expansion and distalization appliances, (2) visible wear facets in the dentition during treatment, (3) history of trauma, craniofacial syndrome, or missing teeth, and (4) poor compliance with aligner wearing documented on the chart. The second molars of several cases were absent or erupting and therefore excluded from the analysis. Accordingly, this study comprised 150 teeth (50 first premolars, 50 second premolars, and 50 first molars) selected from 25 participants (17 females and 8 males), aged from 12 to 44 years old with a mean age of 24.8 ± 8.8 years. Of the 25 patients, 4 were Class I, 15 were Class II, and 6 were Class III malocclusions, all less than 2 mm. The average number of trays was 24.8 ± 11.2, and the average treatment duration was 214 ± 131 days. Among the 150 maxillary posterior teeth, there were 63 teeth without any attachment, 7 with conventional, and 80 with optimized attachments.
Mean ICCs for intra-examiner reliability were greater than 0.990, suggesting the intra-examiner agreement was excellent (Table 1). The results of Bland-Altman analyses are reported in Table 2, which also showed high intra-examiner agreement.
Table 3 shows the angular and linear differences between the predicted and achieved tooth position in maxillary posterior teeth. In general, the angular measures for rotation, torque, and tip had notably greater variation than the distance measures for buccal-lingual, mesial-distal, and occlusal-gingival translations. The mean rotation differences for first premolars and second premolars were greater than 2° and the 95% confidence interval did not include zero. This suggests that clinically, the maxillary first and second premolars were significantly rotated mesially. Torque for all tooth types substantially deviated from zero, while the mean difference for second premolars and first molars was less than -2°, suggesting all maxillary posterior teeth, especially the second premolars and first molars, had a more clinically relevant buccal crown torque relative to the predicted position.
Hotelling's T-squared test results and the 95% overall confidence intervals with Bonferroni correction for each parameter are presented in Table 4. The results indicate the mean differences in rotation (2.036° ± 4.217°) and torque (-2.913° ± 3.263°) were statistically significantly different from zero, with p-values of 0.023 and 0.0003 respectively.
To further explore the possible effects of attachment use on the accuracy of the prediction, a primary investigation can be visualized in Figure 4, which showed minor differences across different attachments (No, conventional, or optimized attachment). However, this is likely due to low frequencies of conventional attachment.
Figure 1: A workflow of the software usage sequence. Please click here to view a larger version of this figure.
Figure 2: Superimposition of the software-final (predicted) and the post-treatment (achieved) models. (A) Four models from one subject registered in the same coordinate system. Color-coding indicates the pre-treatment and post-treatment models with palates but different dentitions, the software-initial model without a palate and the same dentition as the pre-treatment model, and the softwarefinal model without a palate and the predicted dentition. The method for superimposition is described in the text. (B) The software-predicted final and post-treatment models shown alone. Differences in their tooth positions and orientations were measured in this study. Please click here to view a larger version of this figure.
Figure 3: Dental superimposition with measurements. (A) A segmented first molar from the achieved (post-treatment) model registered to the software-predicted version. The transformation matrix for registration and the root mean square (RMS) of the fit is from CloudCompare's pop-up window. (B) Euler angles and displacements derived from the transformation matrix. Please click here to view a larger version of this figure.
Figure 4: Comparison of prediction differences without attachment with conventional and optimized attachments. Please click here to view a larger version of this figure.
Parameter | Mean | 95% | CI | Significance |
Rotation (°) | 1 | 1 | 1 | 0 |
Torque (°) | 0.991 | 0.982 | 0.996 | 0 |
Tip (°) | 0.992 | 0.983 | 0.996 | 0 |
Buccal-Lingual (mm) | 0.999 | 0.997 | 0.999 | 0 |
Mesial-Distal (mm) | 0.99 | 0.979 | 0.995 | 0 |
Occlusal-Gingival (mm) | 0.998 | 0.996 | 0.999 | 0 |
Table 1: Intra-class correlation coefficients (ICC) for intra-examiner reliability (n = 32 teeth). CI: confidence interval.
Parameter | Mean difference | 95% | CI |
Rotation (°) | 0.032 | -0.045 | 0.137 |
Torque (°) | 0.182 | -0.099 | 0.503 |
Tip (°) | 0.061 | -0.08 | 0.218 |
Buccal-Lingual (mm) | -0.011 | -0.043 | 0.012 |
Mesial-Distal (mm) | 0.008 | -0.033 | 0.048 |
Occlusal-Gingival (mm) | 0.011 | -0.002 | 0.026 |
Table 2: Results of Bland-Altman analyses for intra-examiner agreement (n = 32 teeth). CI: confidence interval.
Para-meter | First Premolar (n=50) | Second Premolar (n=50) | First Molar (n=50) | |||||||||
Mean | SD | 95% | CI | Mean | SD | 95% | CI | Mean | SD | 95% | CI | |
Rotation (°) | 2.801 | 3.881 | 1.767 | 4.023 | 2.472 | 5.265 | 1.195 | 4.148 | 0.835 | 3.004 | 0.098 | 1.74 |
Torque (°) | -1.261 | 1.912 | -1.765 | -0.722 | -3.597 | 3.586 | -4.588 | -2.512 | -3.881 | 3.413 | -4.895 | -2.934 |
Tip (°) | 0.746 | 2.851 | -0.079 | 1.632 | 0.409 | 3.015 | -0.434 | 1.238 | -0.326 | 1.917 | -0.582 | 0.506 |
Buccal-Lingual (mm) | -0.18 | 0.455 | -0.311 | -0.046 | -0.156 | 0.516 | -0.307 | -0.018 | -0.048 | 0.619 | -0.203 | 0.132 |
Mesial-Distal (mm) | 0.143 | 0.535 | -0.006 | 0.309 | 0.155 | 0.56 | -0.01 | 0.299 | 0.213 | 0.618 | 0.041 | 0.392 |
Occlusal-Gingival (mm) | -0.141 | 0.407 | -0.256 | -0.031 | -0.206 | 0.408 | -0.323 | -0.09 | -0.256 | 0.398 | -0.363 | -0.147 |
Table 3: Descriptive statistics for angular and linear differences between the predicted and the achieved tooth position for maxillary first premolars, second premolars, and first molars. Positive values indicated an achieved tooth position more buccal, distal, or occlusal, or with more mesial rotation, more distal crown tip, or more lingual crown torque than the predicted tooth position. SD: standard deviation; CI: confidence interval.
Parameter | Mean | SD | 95% | CI | P |
Rotation (°) | 2.036 | 4.217 | 1.408 | 2.756 | 0.023* |
Torque (°) | -2.913 | 3.263 | -3.411 | -2.388 | 0.0003* |
Tip (°) | 0.374 | 2.641 | -0.049 | 0.8 | 1 |
Buccal-Lingual (mm) | -0.128 | 0.534 | -0.216 | -0.041 | 0.186 |
Mesial-Distal (mm) | 0.17 | 0.569 | -0.076 | 0.258 | 1 |
Occlusal-Gingival (mm) | -0.201 | 0.405 | -0.266 | -0.136 | 0.123 |
Table 4: Comparisons of angular and linear mean prediction differences in all the maxillary posterior teeth measured with Hotelling's T-squared tests with Bonferonni correction. Positive values indicated an achieved tooth position more buccal, distal, or occlusal, or with more mesial rotation, more distal crown tip, or more lingual crown torque than the predicted tooth position. *P < 0.05.
The palatal rugae have a unique configuration at adolescence; they remain constant during growth, are authentic markers for personal identification, and are considered stable anatomic references for maxillary model superimposition24,25,26,27. Dai et al. used this method to compare the achieved and predicted tooth movement of maxillary first molars and central incisors with clear aligners after the first premolar extraction28. The achieved post-treatment model was registered via Rapidform software to the pre-treatment and the planned post-treatment model. They reported statistically significant differences between the predicted and achieved tooth movements. The pre- and post-treatment models were acquired from different sources (alginate impressions and intraoral scans). The measurements of tooth movement were expressed within a coordinate system using the posterior occlusal plane as a transverse plane and the palatal suture as a guide to constructing a midsagittal plane. Since angular and translational parameters for the respective maxillary first molars and upper central incisors were projected onto these planes, it is difficult to compare their results with investigations using different coordinate systems (e.g., a coordinate origin based on a tooth's approximate center of resistance)17,18,19,20,21.
The study was limited to the maxillary arch so the palate and its rugae could be used to register the predicted and achieved models. Previously, model registration has been done using untreated or assumedly stable posterior teeth16,17,18,19, best-fit algorithms20,21, miniscrews26,27, tori29, implants30, the cranial-base31, or other bony structures32. In one of the few previous studies using palatal superimposition to assess clear aligner efficacy, Dai et al. compared the achieved and predicted tooth movements of maxillary first molars and central incisors in extraction cases28, although they did not report individual differences in tooth position and orientation with the six degrees of freedom used in this and other studies20,21.
Anterior teeth were not included in this protocol because the shapes of their clinical crowns were too difficult to orient within the world coordinate system used by CloudCompare to express its transformations. However, the premolars and molars had sufficient occlusal landmarks and facial surface regularity to allow each treated tooth's occlusal surface, long axis, and bounding box to be oriented to the software's origin and world coordinates.
Using a transformation matrix to provide the translational and rotational information describing tooth movement during registration requires adherence to specific conventions. CloudCompare employs the Tait-Bryan convention, in which a ZYX axis rotation sequence is adopted first, followed by the 3D translations from world zero needed to complete the match. As the angles reported in this study reflect the Tait-Bryan convention33, studies using different conventions would produce different results. Aligning the post-treatment tooth to the world origin and coordinates ensured the measurements indicated translation from the tooth's original position and directions determined by each tooth's specific surface anatomy.
Overall, our results showed that the rotation and torque of the achieved tooth position were statistically and clinically significantly different from the predictions, with more mesial rotation and buccal torque after treatment with clear aligners. While rotational movement in maxillary first molars was relatively successful, de-rotation in the first and second premolars was more problematic, suggesting the morphology of premolar crowns might contribute to this difference. These findings are similar to a recent study conducted by Al-Nadawia et al., who found that the accuracy of posterior teeth movements with a 7-day protocol is not as accurate as the 14 days protocol for intrusion, distal intrusion, distal-crown tip, and buccal-crown torque34. In order to determine whether the accuracy of Invisalign had improved with the newer technology, Haouili et al. updated Kravitz et al.'s pioneering study17 and they also found the least overall accuracy with rotation, particularly challenging for canines, premolars, and molars 21.
Translation data showed no statistically significant differences for all three directions, in agreement with previous studies. Simon et al. found that upper molar distalization was the most effectively predicted movement18. A non-statistical but clinically significant prediction difference was noticed for occlusal-gingival movement in the first molars in the current study, which tended to be slightly intruded relative to their predicted positions. Haouili et al. also indicated that although the extrusion of the maxillary incisors improved with the use of optimized extrusion attachments, extrusion of the maxillary and mandibular molars had the lowest accuracy21.
In the present study, tooth movements with attachments were not different from teeth with no attachments in achieving the desired tooth movements. Tooth movements with optimized attachment appeared to be slightly inaccurate with rotational movement. Although teeth with optimized attachment showed more accurate torque tooth movement compared with conventional or no attachments, the overall torque tooth movements were challenging. Kravitz et al. stated that attachments may provide minute clinical improvements with rotational movements compared to no attachments; however, not with a statistical significance16. On the other hand, Simon et al. found that attachments are significantly beneficial when derotating premolars18. Cortona et al. also addressed with a finite study that the most efficient way to derotate mandibular round-shaped teeth was to add a single attachment with a 1.2° of aligner activation35. Nucera et al. systematically reviewed the effects of composite attachments on clear aligner therapy and outlined the contradictory results in the current literature36. The lack of evidence warrants further clinical trials to clarify the influence of attachments and their number, size, shape, and position on each orthodontic movement.
Overall, Invisalign achieved most of its predicted posterior tooth movements in adolescents and adults with mild to moderate malocclusions. Specifically, the predicted de-rotation of the maxillary premolars, and especially the first premolar, was more challenging. All maxillary posterior teeth tended to torque buccally without adequate torque control. The more distally positioned the tooth, the more unpredictable the result. With or without attachments or different types of attachments seemed to make no difference in the prediction. Generally, additional refinements or overcorrection would be necessary to achieve all predictions. Comparisons of Invisalign-predicted with clinically achieved digital models in the maxillary arch can benefit from model registration using both palatal and dental features, individual tooth segmentation, and the mathematical transformations used to match them.
The authors have nothing to disclose.
This work was financed by the International Align Research Award Program (Align Technology Inc., Tempe, AZ). However, the funding source had no involvement in the conduct of the research and/or preparation of the article. We would like to thank Dr. Sandra Tai and Dr. Samuel Tam for their generous support for providing the Invisalign cases and Nikolas Krstic for his professional support for statistic analyses.
CloudCompare | GPL software | Version 2.11 | open-source software (https://www.cloudcompare.net/) |
Meshmixer software | Autodesk, Inc. | ||
Rhinoceros 5.0 | Robert McNeel & Associates | Version 5.0 |