Cleft lip and palate surgery simulator: Open source simulation model.

Objective: Cleft lip and palate is the most common craniofacial birth anomaly and requires surgery in the first year of life. However, craniofacial surgery training opportunities are limited. The aim of this study was to present and evaluate an open-source cleft lip and palate hybrid (casting and three-dimensional (3D) printing) simulation model which can be replicated at low cost to facilitate the teaching and training of cleft surgery anatomy and techniques. Design: The soft tissue component of the cleft surgery training model was casted using a 3D printed 5-component mold and silicone. The bony structure was designed to simulate the facial anatomy and to hold the silicone soft tissue. Setting: Two groups, one group of trainees and one group of expert surgeons, at University Hospital Basel in Switzerland and Pontifical Catholic University of Chile in Santiago, Chile, tested the cleft lip and palate simulation model. Participants completed a Likert-based face and content validity questionnaire to assess the realism of the model and its usefulness in surgical training. Results: More than 70 % of the participants agreed that the model accurately simulated human tissues found in patients with unilateral cleft lip and palate. Over 60 % of the participants also agreed that the model realistically replicated surgical procedures. In addition, 80-90 % of the participants found the model to be a useful and appropriate tool for teaching the anatomy and surgical techniques involved in performing unilateral cleft lip and palate repair. Conclusion: This open-source protocol provides a cost-effective solution for surgeons to introduce the cleft morphology and surgical techniques to trainees on a regular basis. It addresses the current financial barrier that limits access to commercially available models during the early stages of surgeon training prior to specialization in the field.

Is the collateral circulation pattern in the hard palate affected by cleft deformity?

OBJECTIVES: To evaluate the influence of collateral vascularization on surgical cleft palate closure and deformities. MATERIALS AND METHODS: Corrosion casting was performed using red-colored acrylic resin in twelve fresh adult cadavers with a normal hard palate. Additionally, white-colored barium sulfate was injected into a fetus with a unilateral complete cleft palate, and layer-by-layer tissue dissection was performed. Both substances were injected into the external carotid arteries. Corrosion casting involved dissolving the soft and hard tissues of the orofacial area utilizing an enzymatic solution. RESULTS: In normal palates, bilateral intraosseous infraorbital arteries formed a network in the premaxilla with the intraosseous nasopalatine- and greater palatine arteries (GPAs). The perforating GPAs anastomosed with the sphenopalatine artery sub-branches. Bilateral extraosseous GPA anastomoses penetrated the median palatine suture. Complex vascularization in the retrotuberal area was detected. In the cleft zone, anastomoses were omitted, whereas in the non-cleft zone, enlarged GPAs were distributed along the cleft edges and followed the anatomical course anteriorly to initiate the network with facial artery sub-branches. CONCLUSIONS: The anatomical subunits of the palate exhibited distinct anastomosis patterns. Despite omitted anastomoses with collateral circulation in the cleft zone, arteries maintained their anatomical pattern as seen in the normal specimen in the non-cleft zone. CLINICAL RELEVANCE: Based on the findings in normal- and cleft palates, surgeons may expect developed anastomosis patterns in the non-cleft zone. Due to the lack of microcirculation in the cleft zone, the existent anastomoses should be maintained as much as possible by the surgical technique. This applies anteriorly in the incisive canal territory, alveolar ridges, and posteriorly in the retrotuberal area.

Comparative study on cleft palate morphology after passive presurgical plate therapy in unilateral cleft lip and palate.

BACKGROUND: Presurgical plate therapy has been widely accepted as a treatment prior to palatal cleft closure. The effects of passive presurgical plate therapy on cleft morphology prior to single-stage unilateral cleft lip and palate (UCLP) repair were quantified. PATIENTS AND METHODS: We compared the dimensions of cleft width and cleft area (true cleft and palatal cleft) measured preoperatively at 2 European cleft centers. Center A performed single-stage UCLP repair in 8-month-old infants without any presurgical orthopedic treatment. Center B initiated passive presurgical plate therapy immediately after the birth of the neonates, followed by single-stage UCLP repair at 8 months of age. RESULTS: We included 28 patients with complete UCLP from Center A and 12 patients from Center B. The average anterior width of the true cleft before surgery was significantly smaller in infants at Center B than that in Center A (p = 0.001) with 95% confidence interval of (1.8, 5.7) mm, but the average posterior width was similar in the 2 groups. The mean presurgical true cleft area amounted to 106.8 mm2 (SD = 42.4 mm2) at Center A and 71.9 mm2 (SD = 32.2 mm2) at Center B, with a confidence interval for the difference being (9.8, 60.1) mm2. This corresponded to a 32.7% reduction of the true cleft area when passive presurgical plate therapy was used for the first 8 months of the infants' life. CONCLUSION: Passive presurgical plate therapy in UCLP significantly reduced the cleft area. Implications for the subsequent surgical outcome might depend on the surgical technique used.

Three-Dimensional Printable Open-Source Cleft Lip and Palate Impression Trays: A Single-Impression Workflow.

SUMMARY: Documenting complex three-dimensional (3D) cleft lip and palate malformation with plaster casts based on maxillary impressions is standard care. Presurgical orthopedic treatment also requires an impression. Digital impression-taking in patients with cleft lip and palate is feasible, but procurement costs hinder clinical implementation. Individualized impression trays allow for a precise impression, limiting airway risk. The authors present an open-source impression tray library with scalable impression trays not requiring 3D modeling knowledge. The cleft lip and palate impression tray library is accessible on Open Science Framework. Different shapes are available, and the tray size is selected based on the tuber distance. This allows 3D printing with biocompatible material at the point of care complying with local regulations. The open-source cleft tray library presented offers a hybrid solution for cleft centers, pending the implementation of digital impression.

Automated and data-driven plate computation for presurgical cleft lip and palate treatment.

PURPOSE: Presurgical orthopedic plates are widely used for the treatment of cleft lip and palate, which is the most common craniofacial birth defect. For the traditional plate fabrication, an impression is taken under airway-endangering conditions, which recent digital alternatives overcome via intraoral scanners. However, these alternatives demand proficiency in 3D modeling software in addition to the generally required clinical knowledge of plate design. METHODS: We address these limitations with a data-driven and fully automated digital pipeline, endowed with a graphical user interface. The pipeline adopts a deep learning model to landmark raw intraoral scans of arbitrary mesh topology and orientation, which guides the nonrigid surface registration subsequently employed to segment the scans. The plates that are individually fit to these segmented scans are 3D-printable and offer optional customization. RESULTS: With the distance to the alveolar ridges closely centered around the targeted 0.1 mm, our pipeline computes tightly fitting plates in less than 3 min. The plates were approved in 12 out of 12 cases by two cleft care professionals in a printed-model-based evaluation. Moreover, since the pipeline was implemented in clinical routine in two hospitals, 19 patients have been undergoing treatment utilizing our automated designs. CONCLUSION: The results demonstrate that our automated pipeline meets the high precision requirements of the medical setting employed in cleft lip and palate care while substantially reducing the design time and required clinical expertise, which could facilitate access to this presurgical treatment, especially in low-income countries.

Digital impressions from newborns to preschoolers with cleft lip and palate: A two-centers experience.

BACKGROUND: Documenting cleft lip and palate morphology prior to surgery is standard care. Presurgical orthopedic treatment also requires a 3D cleft model. Endangering the airway, conventional impressions require additional safety measures and resources. We investigate the implementation and risks of digital impressions for the youngest patients with orofacial clefts. METHODS: We report a retrospective cohort study of patients with cleft lip and palate, aged up to 6 years, treated at two cleft centers in Europe (Basel (A), Warsaw (B)). We scanned with the Medit i500 (Medit Corp, Seoul, South Korea). Center A for presurgical orthopedics and prior surgery from June 2020 to March 2022. Center B prior surgery from December 2020 to May 2021. Scanning data were analyzed for adverse events and adverse device effects, scanning duration, and number of images according to cleft type and age. RESULTS: We analyzed 342 digital impressions in 190 patients (center A: 71, B: 119). The median age was 8.7 months with a range from the first day of birth (presurgical orthopedics) to six years of life (early alveolar bone grafting). No adverse events or adverse device effects were observed. The median scan duration was 85.5 s for cleft palate and 50 s for cleft lip and nose (IQR 56 s and 39 s, respectively). CONCLUSION: Digital impressions with intraoral scanners are safe in patients with cleft lip and palate from newborn to preschool age. Given the funding to purchase an intraoral scanner, interfaces to electronic patient records, and point-of-care 3D printing, cleft centers can successfully implement this technology.

Craniofacial Growth at Age 6-11 Years after One-Stage Cleft Lip and Palate Repair: A Retrospective Comparative Study with Historical Controls.

BACKGROUND: Primary alveolar bone grafting inhibits craniofacial growth. However, its effect on craniofacial growth in one-stage cleft lip and palate protocols is unknown. This study investigated whether primary alveolar bone grafting performed during one-stage unilateral cleft lip and palate repair negatively affects growth up to 6-11 years old. METHODS: The craniofacial growth, dental arch relationship and palatal morphology at 6-11 years old in children with unilateral cleft lip and palate were compared retrospectively. Two cohorts after a one-stage protocol without (Group A) and with (Group B) primary bone grafting at the same center were compared. Further, cephalometric measurements for growth were compared with an external cohort of a one-stage protocol and a heathy control. RESULTS: Group A comprised 16 patients assessed at 6.8 years (SD 0.83), and Group B comprised 15 patients assessed at 9 years (SD 2.0). Cephalometric measurements indicated similar sagittal maxillary growth deficits and a significant deviation in maxillary inclination in both groups compared to the healthy group. Moderate to severe changes in palatal morphology were observed in 70% of the members in both groups. CONCLUSION: Omitting primary alveolar bone grafting under the one-stage protocol with two-flap palatoplasty studied did not improve growth at 6-11 years. The results implicate two-flap palatoplasty with secondary healing as having greater adverse effects on growth than primary alveolar bone grafting. Dental and palatal morphology was considerably compromised regardless of primary alveolar bone grafting.

A Point-of-Care Digital Workflow for 3D Printed Passive Presurgical Orthopedic Plates in Cleft Care.

Cleft lip and palate are one of the most common congenital craniofacial malformations. As an initial treatment, presurgical orthopedics is considered standard treatment at many cleft centers. Digital impressions are becoming feasible in cleft care. Computer-aided design (CAD) and three-dimensional (3D) printing are manufacturing standards in dentistry. The assimilation of these technologies has the potential to alter the traditional workflow for the fabrication of customized presurgical orthopedic plates. We present a digital workflow comprising three steps: 3D digital image acquisition with an intraoral scanner, open-source CAD modeling, and point-of-care 3D printing for the fabrication of personalized passive presurgical plates for newborns with cleft lip and palate. The digital workflow resulted in patient-related benefits, such as no risk of airway obstruction with quicker data acquisition (range 1-2.5 min). Throughput time was higher in the digital workflow 260-350 min compared to 135 min in the conventional workflow. The manual and personal intervention time was reduced from 135 min to 60 min. We show a clinically useful digital workflow for presurgical plates in cleft treatment. Once care providers overcome procurement costs, digital impressions, and point-of-care 3D printing will simplify these workflows and have the potential to become standard for cleft care.

Continuous circular closure in unilateral cleft lip and plate repair in one surgery.

The study aims at assessing wound healing and safety of single-stage two-layers continuous closure in patients with unilateral cleft lip and palate (UCLP). In this retrospective, descriptive cohort study, we assessed wound healing without fistula formation at 1, 3, and 6 months after a single-stage two-layer UCLP repair, in which the midline suture is continuously circular all along the oral and nasal sides. We examined lengths of hospital stay and the incidence of intra- and postoperative adverse events. Furthermore, we compared the cleft width at birth and on the day of surgery, after presurgical orthopaedics. Eleven UCLP patients underwent one cleft surgery between July 2016 and June 2018 at the age of 8-9 months. Full primary healing occurred in all patients without fistulas. Median length of post-operative hospital stay was 5 days (range = 4-9 days). No intra- or postoperative adverse events above Grade I (according to ClassIntra and Clavien-Dindo, respectively) occurred. Median and interquartile range (IQR) of the palatal cleft width decreased significantly from birth to surgery, i.e., from 12.0 mm (10.8-13.6 mm) to 5.0 mm (4.0-7.5 mm) anteriorly and from 14.0 mm (11.5-15.0 mm) to 7.3 mm (6.0-8.5 mm) posteriorly (p = 0.0033 in both cases). Given these preliminary results, the concept of single-stage continuous circular closure in UCLP has potential for further investigation. However, it remains to be proven that there are no relevant adverse effects such as inhibition of maxillary growth. Registered in clinicaltrials.gov:NCT04108416.

Cold Ablation Robot-Guided Laser Osteotome (CARLO®): From Bench to Bedside.

BACKGROUND: In order to overcome the geometrical and physical limitations of conventional rotating and piezosurgery instruments used to perform bone osteotomies, as well as the difficulties in translating digital planning to the operating room, a stand-alone robot-guided laser system has been developed by Advanced Osteotomy Tools, a Swiss start-up company. We present our experiences of the first-in-man use of the Cold Ablation Robot-guided Laser Osteotome (CARLO®). METHODS: The CARLO® device employs a stand-alone 2.94-µm erbium-doped yttrium aluminum garnet (Er:YAG) laser mounted on a robotic arm. A 19-year-old patient provided informed consent to undergo bimaxillary orthognathic surgery. A linear Le Fort I midface osteotomy was digitally planned and transferred to the CARLO® device. The linear part of the Le Fort I osteotomy was performed autonomously by the CARLO® device under direct visual control. All pre-, intra-, and postoperative technical difficulties and safety issues were documented. Accuracy was analyzed by superimposing pre- and postoperative computed tomography images. RESULTS: The CARLO® device performed the linear osteotomy without any technical or safety issues. There was a maximum difference of 0.8 mm between the planned and performed osteotomies, with a root-mean-square error of 1.0 mm. The patient showed normal postoperative healing with no complications. CONCLUSION: The newly developed stand-alone CARLO® device could be a useful alternative to conventional burs, drills, and piezosurgery instruments for performing osteotomies. However, the technical workflow concerning the positioning and fixation of the target marker and the implementation of active depth control still need to be improved. Further research to assess safety and accuracy is also necessary, especially at osteotomy sites where direct visual control is not possible. Finally, cost-effectiveness analysis comparing the use of the CARLO® device with gold-standard surgery protocols will help to define the role of the CARLO® device in the surgical landscape.

Three-Dimensional Morphological Changes of the True Cleft under Passive Presurgical Orthopaedics in Unilateral Cleft Lip and Palate: A Retrospective Cohort Study.

The aim of this cohort study was to quantify the morphological changes in the palatal cleft and true cleft areas with passive plate therapy using a new analysis method based on three-dimensional standardized reproducible landmarks. Forty-five casts of 15 consecutive patients with complete unilateral cleft lip and palate were laser scanned and investigated retrospectively. The landmarks and the coordinate system were defined, and the interrater and intrarater measurement errors were within 1.0 mm. The morphological changes of the cleft palate area after a period of 8 months of passive plate therapy without prior lip surgery are presented graphically. The median decrease in cleft width was 38.0% for the palatal cleft, whereas it was 44.5% for the true cleft. The width of the true and palatal cleft decreased significantly over a period of 8 months. The true cleft area decreased by 34.7% from a median of 185.4 mm2 (interquartile range, IQR = 151.5-220.1) to 121.1 mm2 (IQR = 100.2-144.6). The palatal cleft area decreased by 31.5% from a median of 334 mm2 (IQR = 294.9-349.8) to 228.8 mm2. The most important clinical considerations are the reproducibility and reliability of the anatomical points, as well as the associated morphological changes. We propose using the vomer edge to establish a validated measuring method for the width, area, and height of the true cleft.

Imaging in Patients with Bisphosphonate-Associated Osteonecrosis of the Jaws (MRONJ).

BACKGROUND: Bisphosphonate-associated osteonecrosis of the jaws (MRONJ/BP-ONJ/BRONJ) is a commonly seen disease. During recent decades, major advances in diagnostics have occurred. Once the clinical picture shows typical MRONJ features, imaging is necessary to determine the size of the lesion. Exposed bone is not always painful, therefore a thorough clinical examination and radiological imaging are essential when MRONJ is suspected. METHODS: In this paper we will present the latest clinical update on the imaging options in regard to MRONJ: X-ray/Panoramic Radiograph, Cone Beam Computed Tomography (CBCT) and Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Nuclear Imaging, Fluorescence-Guided Bone Resection. CONCLUSION: Which image modality is chosen depends not only on the surgeon's/practitioner's preference but also on the available imaging modalities. A three-dimensional imaging modality is desirable, and in severe cases necessary, for extended resections and planning of reconstruction.

Treatment of condylar fractures with an intraoral approach using an angulated screwdriver: results of a multicentre study.

BACKGROUND: This multicentre study aimed to investigate long-term radiographic and functional results following the treatment of condylar fractures using an angulated screwdriver system and open rigid internal fixation with an intraoral surgical approach. METHODS: Twenty-nine patients with a total of 32 condylar fractures were evaluated. The patients were investigated prospectively based on the following variables: age, sex, aetiology, side, location and classification of the fracture, degree of displacement, associated fractures, surgical approach, oral health status, type of osteosynthesis plate, duration of surgery, mouth-opening, complications, and duration of follow-up. RESULTS: The fractures were classified as subcondylar (n = 25) or condylar neck (n = 7). Mean patient age was 36.38 ± 16.60 years. The median duration of postoperative follow-up was 24.39 ± 13.94 months. No joint noise, weakness of the facial nerve, joint pain, or muscle pain was observed. An additional retromandibular approach was necessary to enable the treatment of one subcondylar fracture with medial displacement. CONCLUSION: Subcondylar or condylar neck fractures with medial or lateral displacement can be treated using an intraoral approach with satisfactory results with the advantages of the absence of visible scarring, the avoidance of facial nerve injury, and the ability to obtain rapid access to the fracture.

Cortisol levels and sleep patterns in infants with orofacial clefts undergoing surgery.

BACKGROUND: Traumatic events during early infancy might damage infants' psychobiological functioning, such as sleep and cortisol secretion. Infants born with orofacial clefts (OFCs) undergo functional, anatomical, and aesthetic surgery. The aim of the present study was to determine whether infants with OFC and undergoing OFC surgery show deteriorated sleep and cortisol secretion compared with healthy controls and with their presurgery status. METHODS: A total of 27 infants with OFC (mean age: 22 weeks) and 30 healthy controls (mean age: 23 weeks) took part in the study. For infants with OFC, sleep actigraphy was performed and saliva cortisol was analyzed 5 days before, during, and 5 days after surgery. For controls, sleep and saliva cortisol were assessed similarly, except for the period taken up with surgery. RESULTS: Compared with healthy controls, infants with OFC undergoing OFC surgery did not differ in sleep and cortisol secretion. Their sleep and cortisol secretion did deteriorate during the perisurgical period but recovered 5 days postsurgery. CONCLUSION: In infants with OFC undergoing corrective surgery, the pattern of results for sleep and cortisol suggests that OFC surgery does not seem to constitute a traumatic event with long-term consequences.

Osteoblastic differentiation of Wharton jelly biopsy specimens and their mesenchymal stromal cells after serum-free culture.

BACKGROUND: Cleft lip and cleft palate are increasingly being detected by prenatal ultrasound, which raises the opportunity of using the patient's own osteogenicity from umbilical cord mesenchymal cells for bony repair. The authors address the growth of the cells under a fully defined and regulated protocol. METHODS: Wharton jelly-derived mesenchymal stromal cells were isolated and expanded as a monolayer with defined serum-free medium. Osteoblastic differentiation was tested in the cells and in the entire Wharton jelly biopsy specimens. The serum-free-cultured cells were included in hydroxyapatite granule-fibrin constructs and, without predifferentiation, subcutaneously implanted into immunoincompetent mice. RESULTS: Isolation and expansion of Wharton jelly-derived mesenchymal stromal cells were consistently successful under serum-free conditions, and the cells expressed standard mesenchymal stromal cell markers. The serum-free-cultivated cells produced a mineralized extracellular matrix under osteogenic differentiation, with a significant increase of osteoblastic lineage gene expression (Hox-A10 and Runx2) and an up-regulation of downstream osteogenic genes (OSX, OCN, ALPL, and BSP2). In vivo, they formed a dense matrix adjacent to the granules after 8 weeks, but no lamellar bone. serum-free-cultivated entire Wharton jelly biopsy specimens produced a mineralized extracellular matrix within the collagen matrix of the Wharton jelly. CONCLUSIONS: The osteogenic differentiation potential of Wharton jelly-derived mesenchymal stromal cells was maintained under serum-free isolation and expansion techniques. The cells without predifferentiation form a dense collagen matrix but not bone in vivo. Moreover, entire Wharton jelly biopsy specimens showed periosteal-like mineralization under osteogenic differentiation, which offers new options for autologous bone tissue engineering, including cleft palate surgery.

Intraoperative vascular anatomy, arterial blood flow velocity, and microcirculation in unilateral and bilateral cleft lip repair.

BACKGROUND: Cleft lip repair aims to normalize the disturbed anatomy and function. The authors determined whether normalization of blood circulation is achieved. METHODS: The authors measured the microcirculatory flow, oxygen saturation, and hemoglobin level in the lip and nose of controls (n = 22) and in patients with unilateral and bilateral cleft lip-cleft palate. The authors measured these parameters before lip repair (n = 29 and n = 11, respectively), at the end of lip repair (n = 27 and 10, respectively), and in the late postoperative period (n = 33 and n = 20, respectively). The arterial flow velocity was measured in unilateral groups at the same time points (n = 13, n = 11, and n = 12, respectively). Statistical differences were determined using analysis of variance. RESULTS: Before surgery, the arterial flow velocities and microcirculation values were similar on each side of the face and between groups. The microcirculatory flow was significantly higher in the prolabium of bilateral patients than in the philtrum of controls. All circulation values in unilateral and bilateral patients in the late postoperative period were within the range of controls and of those before surgery. Intraoperatively, the authors consistently found a perforating artery on the superficial side of the transverse nasalis muscle. CONCLUSIONS: There appears to be no intrinsic circulatory deficit in unilateral and bilateral cleft lip-cleft palate patients. The increased flow in the prolabium indicates a strong hemodynamic need in this territory, compelling its vascular preservation. Whether surgical preservation of the nasalis perforator artery is of long-term benefit should be addressed in future studies. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

One-stage cleft repair outcome at age 6- to 18-years -- a comparison to the Eurocleft study data.

The optimisation of the relation between quality of outcome and burden of care is difficult in the treatment of cleft lip and palate. We analysed long-term outcome after one-stage repair of clefts to assess the benefits and limitations of this form of treatment. Thirty-three patients aged 6-18 years who had had lip repair, two-flap palatoplasty, and corticocancellous alveolar bone grafts at 6 months of age were divided into three age groups (6-11, 12-14, and 15-18 years) and compared with mean outcome data from the Eurocleft centres and with cephalometric standards of healthy people. Fifteen of the 33 patients were assessed for nasalance. Maxillary protrusion (SNA) and intermaxillary relation (ANB) in the one-stage groups differed significantly from those of healthy people, but not from corresponding means in the Eurocleft study. In 61% the Bergland score for alveolar ossification was grade I or II, and in 15% it was grade III; 24% had secondary alveolar bone grafting. No palatal fistulas occurred and nasalance did not differ significantly from that of healthy controls. As each patient generally had a primary operation and one secondary procedure, they benefited from half the number of surgical steps of multistage procedures. However, one-stage procedures led to significant disturbance in growth, but the degree of this was similar to mean values of multistage procedures in the Eurocleft study. Primary alveolar bone grafting led to inconsistent alveolar ossification and was suspected to interfere with anterior maxillary growth so it has been abandoned.

Early dural reaction to polylactide in cranial defects in rabbits.

Restoring the bone integrity to injured calvariae remains a challenge to surgeons. In this study, the dural biocompatibility of biodegradable poly-L/DL-lactide 80/20 and 70/30 defect covers, designed for guided bone regeneration, was assessed. In each of the 16 test rabbits, bilateral (8.3 mm) cranial defects were created. The different covers were applied to one defect each in every rabbit and consisted of three parts: an epicranial cover, a spacer, and a dural cover. All defects had closed after 8 weeks due to new bone formation. A few giant cells were found at the cover-to-dura interface in equal numbers for both covers. Dural bone formation was present in 15 of 16 rabbits and progressed unhindered by the defect cover or its early degradation products.