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Dipyridamole Augments Three-Dimensionally Printed Bioactive Ceramic Scaffolds to Regenerate Craniofacial Bone

Lopez, Christopher D; Diaz-Siso, J Rodrigo; Witek, Lukasz; Bekisz, Jonathan M; Gil, Luiz F; Cronstein, Bruce N; Flores, Roberto L; Torroni, Andrea; Rodriguez, Eduardo D; Coelho, Paulo G
BACKGROUND:Autologous bone grafts remain a standard of care for the reconstruction of large bony defects, but limitations persist. The authors explored the bone regenerative capacity of customized, three-dimensionally printed bioactive ceramic scaffolds with dipyridamole, an adenosine A2A receptor indirect agonist known to enhance bone formation. METHODS:Critical-size bony defects (10-mm height, 10-mm length, full-thickness) were created at the mandibular rami of rabbits (n = 15). Defects were replaced by a custom-to-defect, three-dimensionally printed bioactive ceramic scaffold composed of β-tricalcium phosphate. Scaffolds were uncoated (control), collagen-coated, or immersed in 100 μM dipyridamole. At 8 weeks, animals were euthanized and the rami retrieved. Bone growth was assessed exclusively within scaffold pores, and evaluated by micro-computed tomography/advanced reconstruction software. Micro-computed tomographic quantification was calculated. Nondecalcified histology was performed. A general linear mixed model was performed to compare group means and 95 percent confidence intervals. RESULTS:Qualitative analysis did not show an inflammatory response. The control and collagen groups (12.3 ± 8.3 percent and 6.9 ± 8.3 percent bone occupancy of free space, respectively) had less bone growth, whereas the most bone growth was in the dipyridamole group (26.9 ± 10.7 percent); the difference was statistically significant (dipyridamole versus control, p < 0.03; dipyridamole versus collagen, p < 0.01 ). There was significantly more residual scaffold material for the collagen group relative to the dipyridamole group (p < 0.015), whereas the control group presented intermediate values (nonsignificant relative to both collagen and dipyridamole). Highly cellular and vascularized intramembranous-like bone healing was observed in all groups. CONCLUSION:Dipyridamole significantly increased the three-dimensionally printed bioactive ceramic scaffold's ability to regenerate bone in a thin bone defect environment.
PMID: 31033822
ISSN: 1529-4242
CID: 3854182

Midface Growth in Patients With Unilateral Cleft Lip and Palate Treated With a Nasoalveolar Molding Protocol

Rubin, Marcie S; Clouston, Sean A P; Esenlik, Elçin; Shetye, Pradip R; Flores, Roberto L; Grayson, Barry H
This retrospective cohort study aimed to determine the impact of a nasoalveolar molding (NAM) protocol on midface growth in school-aged children with non-syndromic unilateral cleft lip and palate (UCLP). Data from 56 consecutively treated, NAM-prepared, Caucasian patients with non-syndromic UCLP from a single US cleft palate center were compared to pooled center data based on 56 patients with non-syndromic UCLP treated at 2 Eurocleft centers that did not use presurgical infant orthopedics (non-PSIO). Lateral cephalograms were obtained and 28 landmarks were identified. Published cephalometric measurements from Eurocleft centers were used for comparison. Seven cephalometric measurements (SNA, SNB, ANB, A'N'B', G'-Sn'-Pg', Sn-CT-LS, ANS-Me/N-Me%), available or derivable for both centers, were analyzed. Means and standard deviations for the 7 measurements were calculated for the NAM center. Student's t-tests were used to compare group means for 6 of the measures and a test of proportion was used for ANS-Me/N-Me%. No significant differences were found between the NAM protocol-prepared group and the Eurocleft non-PSIO centers on any of the 7 analyzed cephalometric relationships after accounting for false discovery rate. The NAM treatment protocol does not appear to impact skeletal or soft tissue facial growth in school-aged children with non-syndromic UCLP.
PMID: 30950956
ISSN: 1536-3732
CID: 3826272

Three-Dimensional Affordable Stone Models for Cleft Lip Markings: A Prospective Study of Learner Satisfaction

Kantar, Rami S; Gonchar, Marina; Maliha, Samantha G; Ramly, Elie P; Alfonso, Allyson R; Cohen, Oriana; Eisemann, Bradley S; Diaz-Siso, J Rodrigo; Saadeh, Pierre B; Flores, Roberto L
INTRODUCTION/BACKGROUND:Knowledge of surgical markings for unilateral cleft lip (UCL) repair is critical for surgical competency. However, few appropriate models are accessible to residents and affordable and accurately reproduce this 3-dimensional (3D) deformity. We propose that cleft care units have the capability of creating affordable 3D stone models to teach UCL markings. METHODS:Polyvinyl siloxane and SnapStone were used to create UCL stone models. Thirteen plastic surgery residents were prospectively recruited, provided with a textbook chapter and online module for studying surgical markings for UCL repair, and then asked to perform the markings on a UCL stone model and standardized patient photograph. Learner satisfaction was evaluated using a modified survey based on the Student Evaluation of Educational Quality survey. RESULTS:The production time of each model was 10 minutes, whereas the cost was $1.84. Participants reported that the stone model was more stimulating (4.77 ± 0.44 vs 3.92 ± 0.86; U = 38.0; P = 0.008), increased their interest more (4.70 ± 0.48 vs 3.53 ± 1.20; U = 33.5; P = 0.005), allowed better learning (4.61 ± 0.51 vs 3.08 ± 0.86; U = 10.0; P < 0.001), was clearer (4.62 ± 0.51 vs 3.15 ± 0.90; U = 12.5; P < 0.001), and was more effective for learning cleft lip markings (4.77 ± 0.44 vs 3.08 ± 1.04; U = 9.0; P < 0.001). They were also more likely to recommend it (4.85 ± 0.38 vs 3.15 ± 1.07; U = 7.0; P < 0.001). CONCLUSIONS:Plastic surgery residents report that 3D cleft lip stone models are superior training tools to learn cleft lip markings compared with patient photographs. These educational tools have the potential to overcome significant financial, logistic, and time constraints in teaching cleft lip surgery markings.
PMID: 31008789
ISSN: 1536-3708
CID: 3821312

Foundation-Based Cleft Care in Developing Countries

Kantar, Rami S; Cammarata, Michael J; Rifkin, William J; Diaz-Siso, J Rodrigo; Hamdan, Usama S; Flores, Roberto L
BACKGROUND:Cleft deformities of the lip and palate affect nearly one in 500 to 700 births, and lead to increased morbidity and mortality if untreated. Nevertheless, significant global disparities in access to timely and appropriate care still exist. The relatively basic infrastructure required to surgically correct these deformities and large unmet disease burden have resulted in a significant number of foundation-based cleft care initiatives focused on developing countries. In this study, the authors evaluate the peer-reviewed literature generated by these foundations in an attempt to assess their clinical, scientific, educational, and economic impact. METHODS:A comprehensive review of the literature was performed using key search terms, and the level of evidence of identified articles was determined. Data were then analyzed to determine the different models of foundation-based cleft care in developing countries, and their clinical, scientific, educational, and economic impact. RESULTS:A total of 244 articles were identified through the authors' search and reviewed. Foundation-based cleft care initiatives in developing countries have significantly contributed to a better understanding of disease epidemiology, barriers to care, safety considerations, complications and outcomes, and international and local cleft surgery education. The cleft care center model is more cost-effective than the surgical mission model and provides more sustainable care. CONCLUSIONS:Foundation-based cleft care prevents significant morbidity in developing countries and has provided valuable resources for capacity building. The surgical mission model should be considered as a transitory conduit for establishing the more effective and sustainable cleft care center model of care.
PMID: 30921141
ISSN: 1529-4242
CID: 3778902

The Nasoalveolar Molding (NAM) Treatment Protocol

Flores, Roberto L; Shetye, Pradip R
PMID: 30884969
ISSN: 1545-1569
CID: 3734912

Effect on Facial Growth of the Management of Cleft Lip and Palate

Farber, Scott J; Maliha, Samantha G; Gonchar, Marina N; Kantar, Rami S; Shetye, Pradip R; Flores, Roberto L
Treatment of cleft lip and palate ordinarily requires multiple interventions spanning the time of birth to adulthood. Restriction of facial growth, a common occurrence in affected children, is due to multiple factors. There are multiple surgical and therapeutic options, which may have influence on facial growth in these patients. As restriction to facial development can have significant implications to form, function, and psychological well-being, practitioners should have an appreciation for the effects of the different cleft therapies to facial growth. We have outlined and thoroughly reviewed in chronological order all of the interventions from birth to adulthood necessary in the comprehensive care of the patient with cleft lip and palate, along with the effects they may or may not have on facial growth.
PMID: 30882417
ISSN: 1536-3708
CID: 3734822

Reply: Outpatient versus Inpatient Primary Cleft Lip and Palate Surgery: Analysis of Early Complications

Kantar, Rami S; Flores, Roberto L
PMID: 30817672
ISSN: 1529-4242
CID: 3698582

Fronto-Orbital Advancement: Description of Surgical Technique to Complement the Procedural Cognition Simulation in the Craniofacial Interactive Virtual Assistant-Professional Edition

Staffenberg, David A; Diaz-Siso, J Rodrigo; Flores, Roberto L
The surgical treatment of nonsyndromic craniosynostosis is one of the most common procedures performed by craniofacial surgeons. However, for residents and fellows, the high degree of difficulty and complex anatomy may result in slow progress along a steep learning curve. This is particularly important in the context of contemporary academic practice, where work-hour limits and other factors restrict operative exposure and opportunities for trainees to learn. These issues have prompted the development of surgical simulation modalities that, while prevalent in other surgical specialties, have not been fully adopted in reconstructive surgery.Among these resources is the Craniofacial Interactive Virtual Assistant - Professional Edition (CIVA-Pro), a procedural cognition simulator that is free of charge. By integrating 3-dimensional virtual animation, voice over, and high-definition intraoperative video, CIVA-Pro describes cardinal craniofacial surgery procedures in an engaging platform. In this study, a detailed, step-by-step description of the fronto-orbital advancement surgical technique to complement the corresponding CIVA-Pro module was presented. This synergistic combination of multimedia educational resources provides a unique didactic option for current trainees to prepare for surgery.
PMID: 30676451
ISSN: 1536-3732
CID: 3610652

A Prospective Randomized Blinded Trial Comparing Digital Simulation to Textbook for Cleft Surgery Education

Plana, Natalie M; Rifkin, William J; Kantar, Rami S; David, Joshua A; Maliha, Samantha G; Farber, Scott J; Staffenberg, David A; Grayson, Barry H; Diaz-Siso, J Rodrigo; Flores, Roberto L
BACKGROUND:Simulation is progressively being integrated into surgical training, yet its utility in plastic surgery has not been well described. We present a prospective, randomized, blinded trial comparing digital simulation to a surgical textbook for conceptualization of cleft-lip repair. METHODS:Thirty-five medical students were randomized to learning cleft repair using a simulator or textbook. Participants outlined markings for a standard cleft-lip repair before (pre-intervention) and after (post-intervention) 20 minutes of studying their respective resource. Two expert reviewers blindly graded markings according to a 10-point scale, on two separate occasions. Intra-rater and inter-rater reliability were calculated using intra-class correlation coefficients. Paired and independent t-tests were performed to compare scoring between study groups. A validated student satisfaction survey was administered to assess the two resources separately. RESULTS:Intra-rater grading reliability was excellent among both raters for pre-intervention and post-intervention grading (rater 1 ICC=0.94 and 0.95, respectively; rater 2 ICC=0.60 and 0.92, respectively; p<0.001). Mean pre-intervention performances for both groups were comparable (0.82±1.17 vs. 0.64±0.95; p=0.31). Significant improvement from pre-intervention to post-intervention performance was observed in the textbook (0.82±1.17 v. 3.50±1.62; p<0.001) and simulator (0.64±0.95 vs. 6.44±2.03; p<0.001) groups. However, the simulator group demonstrated a significantly greater improvement (5.81±2.01 vs. 2.68±1.49; p<0.001). Participants reported the simulator to be more effective (p<0.001) and a clearer tool (p<0.001), that allowed better learning (p<0.001) than textbooks. All participants would recommend the simulator to others. CONCLUSIONS:We present level I evidence supporting online digital simulation as a superior educational resource for novice learners, compared to traditional textbooks.
PMID: 30325894
ISSN: 1529-4242
CID: 3368362

The In-House Manufacture of Sterilizable, Scaled, Patient-Specific 3D-Printed Models for Rhinoplasty

Bekisz, Jonathan M; Liss, Hannah A; Maliha, Samantha G; Witek, Lukasz; Coelho, Paulo G; Flores, Roberto L
Background/UNASSIGNED:Rhinoplasty relies on clear patient communication and precise execution of a three-dimensional (3D) plan to achieve optimal results. As 3D imaging and printing continue to grow in popularity within the medical field, rhinoplasty surgeons have begun to leverage these resources as an aid to preoperative planning, patient communication, and the technical performance of this challenging operation. Objective/UNASSIGNED:Utilizing departmentally-available resources and open access 3D imaging platforms, we have developed an affordable, reproducible protocol for rapid in-house virtual surgical planning (VSP) and subsequent manufacture of 3D-printed rhinoplasty models. Methods/UNASSIGNED:Preoperative 3D photographic images underwent virtual rhinoplasty using a freely-available 3D imaging and sculpting program (BlenderTM [Version 2.78, Amsterdam, The Netherlands]). Once the ideal postoperative result was digitally achieved, scaled, sterilizable and patient-specific 3D models of the preoperative and ideal postoperative result were manufactured in-house using a departmentally-owned 3D printer. Results/UNASSIGNED:3D-printed models have successfully been manufactured and employed for 12 patients undergoing rhinoplasty. The average time to prepare a set of pre- and postoperative models was 3 hours, while the printing process required 18-24 hours per model. Each set of surgical models can be manufactured at a total materials cost of approximately $5.00. Conclusions/UNASSIGNED:We describe an affordable means to construct sterilizable, scaled, patient-specific 3D-printed models for rhinoplasty. This technique may become of increasing interest to academic and cosmetic centers as hardware costs of 3D printers continues to fall.
PMID: 29982464
ISSN: 1527-330x
CID: 3192322