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This study aimed to identify and quantify the variations in PSI designs intended for an identical patient. Records from 10 patients with an orbital fracture involving two walls, for which a primary orbital reconstruction was indicated, were retrospectively included. Clinical engineers from two centers independently generated proposal designs for all patients. Following web meeting(s) with the surgeon from the same institute, the PSI designs were finalized by the engineer. A cross-over of the engineer with the surgeon of the other center created two new design teams. In total, 20 proposal and 40 final PSI designs were produced. A three-dimensional comparison between different PSI designs for the same patient was performed by computing a difference score. Initially, the design proposals of the two engineers showed a median difference score of 37%, which was significantly reduced to a median difference score of 26% for the final designs with different engineers. The median difference score of 22% between surgeons demonstrated that both parties introduced notable user variations to the final designs. Evidence supporting the advantages of an experienced design team was found, with significantly fewer modifications, fewer meetings, and less time required to complete the design (up to 40% time reduction). The findings of the study underline the dependency of PSI design on the surgeon and engineer, and support the need for a more evidence-based protocol for PSI design.

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The study aim was to assess the volumetric, linear, and morphological changes of the maxillary incisor, canine, and premolar roots following Le Fort I osteotomy. Sixty patients (585 teeth) were included retrospectively from among individuals who underwent combined orthodontics and orthognathic surgery. The study group comprised 30 patients who underwent orthodontics and one-piece Le Fort I osteotomy, while the control group consisted of 30 patients who underwent orthodontics and bilateral sagittal split osteotomy but no maxillary surgery. CBCT scans were obtained at four time points: preoperative, 6 months, 1 year, and 2 years postoperative. A fully automated three-dimensional evaluation protocol was utilized to assess root changes of the maxillary teeth. Significant differences in the apical and middle parts of the teeth were observed between the study and control groups at 1 and 2 years postoperative, with greater percentage changes in the study group (all P < 0.05). Greater root remodelling in the canines, first and second premolars was observed in the study group (all P < 0.005). Spearman correlation analysis indicated a positive relationship between root remodelling and maxillary advancement, with larger advancements contributing to increased root remodelling in the apical and middle root parts (both P < 0.05). These findings can be valuable for surgeons and orthodontists in evaluating root changes.

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OBJECTIVE: This study aims to quantify the facial symmetry of surgically treated zygomaticomaxillary complex (ZMC) fractures through a new reliable three-dimensional evaluation method, which is crucial for improving post-operative aesthetic and functional outcomes. MATERIAL AND METHODS: Healthy patients and patients with surgically treated ZMC fractures were retrospectively reviewed. Using Brainlab Elements® the zygomatic bone and the orbit of each patient was segmented and mirrored. Subsequently, the mirrored side was matched with the other side via volume-based registration, using the segmented orbit as reference. Volumetric asymmetry was measured using 3-matic software, and a surface-based matching technique was used to calculate the mean absolute differences (MAD) between the surfaces of the two sides of the ZMC. The reliability of this novel method using volume-based registration was tested, and the intra-class correlation coefficient was assessed. RESULTS: The MAD between the surfaces of the left and right sides in the control group was 0.51 mm (±0.09). As for the ZMC fracture group, MAD was 0.78 mm (±0.20) and 0.72 mm (±0.15) pre- and post-operatively, respectively. The MAD showed statistically significant differences between pre- and post-operative groups (p = 0.005) and between control and post-operative groups (p < 0.001). The intra-class correlation coefficient was high (≥0.99). CONCLUSIONS: This evaluation method using mirroring and volume-based registration to determine the symmetrical position of the ZMC is reliable. The surface-based measurements revealed an improved symmetry after surgery. However, the symmetry of the treated patients remained lower than the control group.

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Objective: Recruitment of a sufficiently large and representative patient sample and its retention during central nervous system (CNS) trials presents major challenges for study sponsors. Technological advances are reshaping clinical trial operations to meet these challenges, and the COVID-19 pandemic further accelerated this development. Method of Research: The International Society for CNS Clinical Trials and Methodology (ISCTM; www.isctm.org) Innovative Technologies for CNS Trials Working Group surveyed the state of technological innovations for improved recruitment and retention and assessed their promises and pitfalls. Results: Online advertisement and electronic patient registries can enhance recruitment, but challenges with sample representativeness, conversion rates from eligible prescreening to enrolled patients, data privacy and security, and patient identification remain hurdles for optimal use of these technologies. Electronic medical records (EMR) mining with artificial intelligence (AI)/machine learning (ML) methods is promising but awaits translation into trials. During the study treatment phase, technological innovations increasingly support participant retention, including adherence with the investigational treatment. Digital tools for adherence and retention support take many forms, including patient-centric communication channels between researchers and participants, real-time study reminders, and digital behavioral interventions to increase study compliance. However, such tools add technical complexities to trials, and their impact on the generalizability of results are largely unknown. Conclusion: Overall, the group found a scarcity of systematic data directly assessing the impact of technological innovations on study recruitment and retention in CNS trials, even for strategies with already high adoption, such as online recruitment. Given the added complexity and costs associated with most technological innovations, such data is needed to fully harness technologies for CNS trials and drive further adoption.

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OBJECTIVE: The present study was taken up to evaluate the combination of two drugs in the management of behavioral disorders such as locomotor activity, muscle relaxation, analgesic, and anxiolytic activity. MATERIALS AND METHODS: In the methodology, Wistar rats weighing (150-180 g) were divided into six groups of 6 each (n=6). All the animals (groups II to VI) were subjected to stress and analyzed for anxiolytic activity using an elevated plus maze. The animals were treated for 28 days with poppy seed oil in lower and higher doses (1,000 and 2,000 mg/kg), tramadol in lower and higher doses (1.5 and 3 mg/kg) as individual groups, and one group with a combination of both drugs in lower doses. RESULTS: The results depicted showed that the combined treatment had significantly (**p <0.001) improvised behavior deficits, extemporized, and diminished anxiety-like attitude in rats, and showed the analgesic property in a significant manner. The pro-inflammatory cytokines TNF-α and IL-1ß were evaluated in the serum and were observed to be lessened the values of both in a significant manner with the co-administration of both the test drugs. The dopamine concentrations were also determined in the serum, which disclosed a decline (**p <0.001) significantly. CONCLUSIONS: It was concluded from the results that a combined effect of drugs might be beneficial in the management of behavioral disorders and pain management.

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Radiation doses in dentomaxillofacial imaging are typically very low. However, diagnostic and follow-up protocols in orthognathic surgery result in a patient-specific risk in effective dose. Estimating the cancer risks from these exposures remains abstract for many maxillofacial surgeons. In this study, 40 orthognathic patients were randomly sampled and their cumulative effective dose (ED) calculated. The lifetime attributable risk of cancer (LAR) was calculated based on the standard radiological protocol for orthognathic surgery follow-up using methods described in the BEIR VII report and RadRAT. The mean cumulative ED of the 40 sampled patients at the end of their 2-year follow-up period was 1.91 ± 0.58 mSv. The LAR at the end of follow-up was 17.65 (90% confidence interval 6.46-32.90) per 100,000 person-years for male orthognathic patients and 13.93 (90% confidence interval 6.27-25.24) per 100,000 person-years for female orthognathic patients. This represents 0.70% and 0.68%, respectively, of the baseline cancer risk for oral, thyroid, and brain cancer combined. Although theoretical, these results provide a framework for interpreting radiation doses and cancer risks in patients undergoing orthognathic surgery. Considering the increased radiation sensitivity in children and adolescents, indication-oriented and patient-specific imaging protocols should be advised.

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Digital therapeutics (DTx) are software programs that treat a disease or condition. Increasingly, DTx are part of medical care, and in the US healthcare system they are regulated by the FDA as Software as a Medical Device (SaMD). Randomized controlled trials (RCT) remain a key evidence generation step for most DTx. However, developing a unified approach to the design of appropriate control conditions has been a challenge for two main reasons: (1) inheriting control condition definitions from pharmacotherapy and medical device RCT that may not directly apply, and (2) challenges in establishing control conditions for psychosocial interventions that build the core of many DTx. In our critical review we summarize different approaches to control conditions and patient blinding in RCT evaluating DTx with psychosocial, cognitive or behavioral content. We identify control condition choices, ranging from very minimal digital controls to more complex and stringent digital applications that contain aspects of "fake" therapy, general wellness content or games. Our review of RCTs reveals room for improvement in describing and naming control conditions more consistently. We further discuss challenges in defining placebo controls for DTx and ways in which control choices may have a therapeutic effect. While no one-size-fits-all control conditions and study designs will apply to all DTx, we propose points to consider for defining appropriate digital control conditions. At the same time, given the rapid iterative development and optimization of DTx, treatments with low risk profile may be evaluated with minimal digital controls followed by extensive real-world effectiveness trials.

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In forensic identification, lack of eccentric characteristics of intact dentitions hinders correct ante-mortem/post-mortem (AM/PM) matching. It remains unclear which morphological dental parameters hold strong potential as identifiers. This study aimed to establish a method to quantify and rank the identifying potential of one (or a combination of) continuous morphological parameter(s), and to provide a proof of concept. First, a statistic was defined that quantifies the identifying potential: the mean potential set (MPS). The MPS is derived from inter-observer agreement data and it indicates the percentage of subjects in the AM reference dataset who at least need to be considered to detect the correct PM subject. This was calculated in a univariate and a multivariate setting. Second, the method was validated on maxillary first molar crowns of 82 3D-digitally scanned cast models. Standardized measurements were registered using 3D modeling software (3-Matic Medical 12.0, Materialise N.V., Leuven, Belgium): tooth depth, angles between cusps, distances between cusps, distances between the cusps, and the mesial pit. A random sample of 40 first molars was measured by a second examiner. Quantifying and ranking the parameters allowed selecting those with the strongest identifying potential. This was found for the tooth depth (1 measurement, MPS = 17.1%, ICC = 0.879) in the univariate setting, and the angles between cusps (4 measurements, MPS = 3.9%) in the multivariate setting. As expected, the multivariate approach held significantly stronger identifying potential, but more measurements were needed (i.e., more time-consuming). Our method allows quantifying and ranking the potential of dental morphological parameters as identifiers using a clear-cut statistic.

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AIM: This study aims to explore the prevalence of Iatrogenic retroposition of the lips sequel (IRLS) after bicuspid extraction, associated dentofacial characteristics and the effectiveness of surgical treatment. MATERIAL: and methods: Patients with bicuspid extraction as part of an orthodontic treatment plan were retrospectively included. IRLS was identified by clinical evaluation and cephalometric Legan and Burstone analysis. Association of demographic and cephalometric variables were assessed. The effectiveness of combined orthodontic-orthognathic correction of the retroposition of the lips was evaluated. RESULTS: Out of 144 patients with extracted bicuspids, eight Class I patients, nine Class II patients and five Class III patients were seeking treatment because their lips had retruded as a consequence of compensating orthodontic treatment. Lower jaw bicuspid extraction and a decreased vertical facial height in Class II patients correlated significantly more with IRLS development. Postoperative cephalometric analysis of orthodontic-orthognathic treated patients reported improvement in lip projection and naso-labial angle. Only two Class I patients reported postoperative normalization of the lip position according to Legan and Burstone. CONCLUSION: The consequence of bicuspid extractions on soft tissue profile differs according to skeletal jaw relation. The impact of orthognathic surgery on IRLS is beneficial, although insufficient to completely correct the facial profile when judged on cephalometric standards.

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The aim of this study was to investigate the prevalence and characteristics of systemic conditions in patients undergoing orthognathic surgery at a tertiary centre. Ninety of the 838 patients undergoing orthognathic surgery between 2013 and 2019 had a systemic condition (prevalence of 10.7%). The most prevalent categories of systemic conditions were inflammatory joint disorders, endocrinological disorders, and syndromes. Patients with syndromes were significantly younger at the time of surgery than patients with endocrinological (P < 0.001), inflammatory joint (P = 0.003), or gastrointestinal disorders (P = 0.033). Endocrinological disorders, syndromes, and malignancies were more frequently associated with a skeletal class III malocclusion (P = 0.009, P < 0.001, and P = 0.048 respectively). Further research is needed to clarify the role of systemic conditions in the aetiology of malocclusion and postoperative outcomes.

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The aim of this study was to perform a three-dimensional evaluation of the skeletal relapse of the proximal and distal mandibular segments following isolated bilateral sagittal split osteotomy advancement surgery. One hundred consecutive patients (mean age 25.8±11.7 years), comprising 65 female patients (mean age 26.4±12.1 years) and 35 male patients (mean age 24.6±11.0 years) requiring mandibular advancement without genioplasty, were enrolled prospectively in the study. Cone beam computed tomography scans were acquired for each patient at three time-points: preoperatively, immediately (1-6 weeks) after surgery, and 1 year after surgery. A validated tool was utilized to assess the surgical movement and relapse. Based on percentage, the majority of the distal and proximal translational and rotational movements relapsed within the range of ≤2mm and ≤2°. The distal segment revealed a significant relapse in a posterior, inferior, and clockwise pitch direction. Both left and right proximal segments showed a significant translational relapse in the medial, posterior, and superior direction. Amongst the rotational parameters, proximal segments relapsed significantly in clockwise pitch, clockwise roll, and counterclockwise yaw direction. Overall, both distal and proximal bone segments showed a clinically acceptable translational and rotational stability. The proximal segments torqued towards their original position with a reduction of flaring.

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Aim: The purpose of the study was to understand the impact of a pain management consult for acute pancreatitis patients on their inpatient length of stay, morphine milligram equivalences (MMEs) and pancreatitis severity. Materials & methods: Adult patient data were extracted from the electronic health records from 1 October 2016 to 31 December 2018. Results & conclusion: Of 277 patients with a single acute pancreatitis hospitalization, 23 had a pain consultation (treatment group), whereas 254 did not (control group). There were statistically significant differences in median length of stay, median MME total and median MME per day between the treatment and control groups with comparable severity and pain scores (6.8 vs 3.1 days, 196.5 vs 33.8 MMEs, 30.9 vs 12.1 MMEs, respectively, p < 0.0001). This study emphasizes the complexity of pain management and the importance of further research in the field.

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The aim of this study was to assess relapse following Le Fort I (LFI) maxillary advancement with superior or inferior repositioning at 2 years of follow-up. A total of 50 patients (26 female, 24 male; age range 15-56 years) with skeletal class II or III, who underwent bimaxillary surgery with LFI maxillary advancement in combination with either superior or inferior repositioning and also mandibular advancement/setback, were recruited. Preoperative (T0), immediate postoperative (T1), and 2-year postoperative (T2) cone beam computed tomography scans were acquired. Data were imported into a validated module to assess the skeletal movement (T0-T1) and relapse (T1-T2). Overall, the majority of the translational and rotational movements showed a relapse of <1 mm and <1°. Patients undergoing maxillary advancement with inferior repositioning in combination with mandibular advancement showed the highest amount of translational relapse in a superior (0.86 ± 0.85 mm, P < 0.0001) and posterior direction (-0.65 ± 1.11 mm, P < 0.0001). In relation to patients who received a bone graft, inferior repositioning with mandibular setback showed the highest maxillary relapse in a superior direction (1.20 ± 1.56 mm, P = 0.0719) with counterclockwise pitch rotation (2.15 ± 0.64°, P = 0.3759). Amongst the non-grafted procedures, superior repositioning with mandibular setback exhibited the highest relapse in a medial direction (1.38 ± 2.78 mm, P = 0.3981). Maxillary advancement was found to be a highly stable procedure with a lack of superoinferior stability in patients undergoing inferior repositioning.

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The aim of the present study was to identify the risk factors for removal of osteosynthesis material after multi-piece Le Fort I osteotomy compared to standard one-piece Le Fort I osteotomy (LF1). Medical files of patients treated with multi-piece or one-piece LF1 were retrospectively reviewed, including the indication for removal and time between insertion and removal. A total of 339 patients were included: 290 patients with LF1 and 49 patients with multi-piece LF1. Patients undergoing multi-piece LF1 had 2.7-times significantly higher (p < 0.001) relative risk of osteosynthesis removal in the upper jaw (42.9%) than patients undergoing LF1 (15.9%). Significant independent predictors of removal of osteosynthesis material after multi-piece LF1 were older age (odds ratio [OR] 1.1, 95% confidence interval [CI] 1.0-1.2; p = 0.028), simultaneous bilateral sagittal split osteotomy (OR 7.8, 95% CI 1.2-50.3; p = 0.031), and no previous surgically assisted rapid palatal expansion (OR 0.14, 95% CI 0.03-0.69; p = 0.15). Significantly higher removal rates of osteosynthesis material were found after multi-piece LF1. Therefore, all patients must be informed of the higher risk for removal of osteosynthesis material when undergoing a multi-piece LF1.

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Automatic craniomaxillofacial (CMF) three dimensional (3D) dense phenotyping promises quantification of the complete CMF shape compared to the limiting use of sparse landmarks in classical phenotyping. This study assesses the accuracy and reliability of this new approach on the human mandible. Classic and automatic phenotyping techniques were applied on 30 unaltered and 20 operated human mandibles. Seven observers indicated 26 anatomical landmarks on each mandible three times. All mandibles were subjected to three rounds of automatic phenotyping using Meshmonk. The toolbox performed non-rigid surface registration of a template mandibular mesh consisting of 17,415 quasi landmarks on each target mandible and the quasi landmarks corresponding to the 26 anatomical locations of interest were identified. Repeated-measures reliability was assessed using root mean square (RMS) distances of repeated landmark indications to their centroid. Automatic phenotyping showed very low RMS distances confirming excellent repeated-measures reliability. The average Euclidean distance between manual and corresponding automatic landmarks was 1.40 mm for the unaltered and 1.76 mm for the operated sample. Centroid sizes from the automatic and manual shape configurations were highly similar with intraclass correlation coefficients (ICC) of > 0.99. Reproducibility coefficients for centroid size were < 2 mm, accounting for < 1% of the total variability of the centroid size of the mandibles in this sample. ICC's for the multivariate set of 325 interlandmark distances were all > 0.90 indicating again high similarity between shapes quantified by classic or automatic phenotyping. Combined, these findings established high accuracy and repeated-measures reliability of the automatic approach. 3D dense CMF phenotyping of the human mandible using the Meshmonk toolbox introduces a novel improvement in quantifying CMF shape.

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The purpose of this study was to validate the applicability of using maxillary voxel-based dentoalveolar registration (VDAR) at long-term follow up in orthognathic surgical patients. A retrospective sample of 25 patients (skeletal class II or III) who underwent bimaxillary orthognathic surgery was recruited and divided into two groups. Group A included 15 patients (seven females, eight males, mean (SD) age 25.8 (14.4) years) with unrestored dentition and group B involved 10 patients (five females, five males, mean (SD) age: 26.2 (11.9) years) with dental restorative treatment. Postoperative cone-beam computed tomography (CBCT) scans were acquired at four time-points, one to six weeks (T1), six months (T2), one year (T3) and two years (T4). Voxel- based registration was applied using the cranial base and then complete dental segment with part of the alveolar bone at T1-T2, T1-T3 and T1-T4 time-intervals. The translational and rotational accuracy and reproducibility of the registered maxillary segment was evaluated at these three intervals by analysing the transformation matrix using singular value decomposition. All translational and rotational measurements showed excellent reliability in both groups without any significant difference. The combined translational and rotational difference was found to be within the clinically acceptable range of 2mm and 4°. The VDAR was found to be accurate and reliable to be utilised for a long-term skeletal follow-up in orthognathic surgical patients.

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Background: Post-stroke aphasia is a chronic condition that impacts people's daily functioning and communication for many years after a stroke. Even though these individuals require sustained rehabilitation, they face extra burdens to access care due to shortages in qualified clinicians, insurance limitations and geographic access. There is a need to research alternative means to access intervention remotely, such as in the case of this study using a digital therapeutic. Objective: To assess the feasibility and clinical efficacy of a virtual speech, language, and cognitive digital therapeutic for individuals with post-stroke aphasia relative to standard of care. Methods: Thirty two participants completed the study (experimental: average age 59.8 years, 7 female, 10 male, average education: 15.8 years, time post-stroke: 53 months, 15 right handed, 2 left handed; control: average age 64.2 years, 7 female, 8 male, average education: 15.3 years, time post-stroke: 36.1 months, 14 right handed, 1 left handed). Patients in the experimental group received 10 weeks of treatment using a digital therapeutic, Constant Therapy-Research (CT-R), for speech, language, and cognitive therapy, which provides evidence-based, targeted therapy with immediate feedback for users that adjusts therapy difficulty based on their performance. Patients in the control group completed standard of care (SOC) speech-language pathology workbook pages. Results: This study provides Class II evidence that with the starting baseline WAB-AQ score, adjusted by -0.69 for every year of age, and by 0.122 for every month since stroke, participants in the CT-R group had WAB-AQ scores 6.43 higher than the workbook group at the end of treatment. Additionally, secondary outcome measures included the WAB-Language Quotient, WAB-Cognitive Quotient, Brief Test of Adult Cognition by Telephone (BTACT), and Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39), with significant changes in BTACT verbal fluency subtest and the SAQOL-39 communication and energy scores for both groups. Conclusions: Overall, this study demonstrates the feasibility of a fully virtual trial for patients with post-stroke aphasia, especially given the ongoing COVID19 pandemic, as well as a safe, tolerable, and efficacious digital therapeutic for language/cognitive rehabilitation. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT04488029.

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The aim of this review was to investigate the skeletal and soft tissue stability of isolated advancement genioplasty after more than 1 year, and to observe the influence of associated risk factors. A literature search was performed on PubMed, Web of Science, Embase, ScienceDirect, and Cochrane. Only studies with at least 10 patients who underwent an isolated advancement genioplasty, and with a follow-up period of at least 1 year, were included. Of the 2224 records initially identified, eight articles met the eligibility criteria. The mean age of the total study population was 23 years and ranged from 19.1 to 26.5 years in the individual studies. The average surgical advancement at pogonion was 8.2 mm and ranged from 6.2 to 11.7 mm in the individual studies. After 1 year, the horizontal hard tissue relapse at the level of pogonion varied from 0.1 to 2.1 mm. In two studies, this was reported as statistically significant. Regarding the soft tissue, the horizontal relapse varied from 0.3 to 2.9 mm, which was also considered statistically significant in two studies. Isolated advancement genioplasty was found to be a predictable and stable orthognathic procedure in the sagittal plane at both soft and hard tissue levels. The amount of relapse was not associated with the fixation method or with the amount of surgical advancement.

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Post-processing analysis can provide valuable information for diagnosis and planning of orbital disorders. This cross-sectional study aims to evaluate the reliability of semi-automatic, orbital fat volumetry using magnetic resonance imaging (MRI). Two observers assessed the orbital fat volume using a standard MRI protocol (3T, T1w sequence) in 12 orbits diagnosed with Graves' orbitopathy (GO) and 10 healthy control orbits. MRI and computed tomography (CT) based analysis were compared. Intra-observer variability was good (intraclass correlation coefficient (ICC) 0.88; 95% confidence interval (CI) [0.70, 0.95]) and interobserver agreement was moderate (ICC 0.55; 95% CI [-0.09, 0.81]), which corresponds to a mean percentage difference of 1.3% and 17.9% of the total orbital fat volume. Mean differences between MRI and CT measurements were, respectively, 1.1 cm3 (P= 0.064, 95% CI [-0.20, 2.43]) and 1.4 cm3 (P=0.016, 95% CI [0.21, 2.56]) for the control and the GO group. MRI volumetry was strongly correlated with CT (Pearson's r= 0.7, P<0.001). We conclude that orbital fat volumetry is feasible with a semi-automatic segmentation procedure and standard MRI protocol. Correlation with CT volumetry is good, but considerable bias may derive from observer variability and these errors should be taken into account for the purpose of volumetric analysis. Better definition of error sources may increase measurement accuracy.

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