Comparison of trueness and repeatability of facial prosthesis design using a 3D morphable model approach, traditional computer-aided design methods, and conventional manual sculpting techniques.

STATEMENT OF PROBLEM: Manually sculpting a wax pattern of a facial prosthesis is a time-, skill-, and resource-intensive process. Computer-aided design (CAD) methods have been proposed as a substitute for manual sculpting, but these techniques can still require high technical or artistic abilities. Three-dimensional morphable models (3DMMs) could semi-automate facial prosthesis CAD. Systematic comparisons of different design approaches are needed. PURPOSE: The purpose of this study was to compare the trueness and repeatability of replacing facial features with 3 methods of facial prosthesis design involving 3DMM, traditional CAD, and conventional manual sculpting techniques. MATERIAL AND METHODS: Fifteen participants without facial defects were scanned with a structured light scanner. The facial meshes were manipulated to generate artificial orbital, nasal, or combined defects. Three methods of facial prosthesis design were compared for the 15 participants and repeated to produce 5 of each design for 2 participants. For the 3DMM approach, the Leeds face model informed the designs in a statistically meaningful way. For the traditional CAD methods, designs were created by using mirroring techniques or from a nose model database. For the conventional manual sculpting techniques, wax patterns were manually created on 3D printed full face baseplates. For analysis, the unedited facial feature was the standard. The unsigned distance was calculated from each of the several thousand vertices on the unedited facial feature to the closest point on the external surface of the prosthesis prototype. The mean absolute error was calculated, and a Friedman test was performed (α=.05). RESULTS: The median mean absolute error was 1.13 mm for the 3DMM group, 1.54 mm for the traditional CAD group, and 1.49 mm for the manual sculpting group, with no statistically significant differences among groups (P=.549). Boxplots showed substantial differences in the distribution of mean absolute error among groups, with the 3DMM group showing the greatest consistency. The 3DMM approach produced repeat designs with the lowest coefficient of variation. CONCLUSIONS: The 3DMM approach shows potential as a semi-automated method of CAD. Further clinical research is planned to explore the 3DMM approach in a feasibility trial.

IMproving facial PRosthesis construction with contactlESs Scanning and Digital workflow (IMPRESSeD): study protocol for a feasibility crossover randomised controlled trial of digital versus conventional manufacture of facial prostheses in patients with orbital or nasal facial defects.

BACKGROUND: Facial prostheses can have a profound impact on patients' appearance, function and quality of life. There has been increasing interest in the digital manufacturing of facial prostheses which may offer many benefits to patients and healthcare services compared with conventional manufacturing processes. Most facial prosthesis research has adopted observational study designs with very few randomised controlled trials (RCTs) documented. There is a clear need for a well-designed RCT to compare the clinical and cost-effectiveness of digitally manufactured facial prostheses versus conventionally manufactured facial prostheses. This study protocol describes the planned conduct of a feasibility RCT which aims to address this knowledge gap and determine whether it is feasible to conduct a future definitive RCT. METHODS: The IMPRESSeD study is a multi-centre, 2-arm, crossover, feasibility RCT with early health technology assessment and qualitative research. Up to 30 participants with acquired orbital or nasal defects will be recruited from the Maxillofacial Prosthetic Departments of participating NHS hospitals. All trial participants will receive 2 new facial prostheses manufactured using digital and conventional manufacturing methods. The order of receiving the facial prostheses will be allocated centrally using minimisation. The 2 prostheses will be made in tandem and marked with a colour label to mask the manufacturing method to the participants. Participants will be reviewed 4 weeks following the delivery of the first prosthesis and 4 weeks following the delivery of the second prosthesis. Primary feasibility outcomes include eligibility, recruitment, conversion, and attrition rates. Data will also be collected on patient preference, quality of life and resource use from the healthcare perspective. A qualitative sub-study will evaluate patients' perception, lived experience and preference of the different manufacturing methods. DISCUSSION: There is uncertainty regarding the best method of manufacturing facial prostheses in terms of clinical effectiveness, cost-effectiveness and patient acceptability. There is a need for a well-designed RCT to compare digital and conventional manufacturing of facial prostheses to better inform clinical practice. The feasibility study will evaluate key parameters needed to design a definitive trial and will incorporate early health technology assessment and a qualitative sub-study to identify the potential benefits of further research. TRIAL REGISTRATION: ISRCTN ISRCTN10516986). Prospectively registered on 08 June 2021,  https://www.isrctn.com/ISRCTN10516986 .

Strategies for the Covalent Anchoring of a BMP-2-Mimetic Peptide to PEEK Surface for Bone Tissue Engineering.

Researchers in the field of tissue engineering are always searching for new scaffolds for bone repair. Polyetheretherketone (PEEK) is a chemically inert polymer that is insoluble in conventional solvents. PEEK's great potential in tissue engineering applications arises from its ability to not induce adverse reactions when in contact with biological tissues and its mechanical properties, which are similar to those of human bone. These exceptional features are limited by the bio-inertness of PEEK, which causes poor osteogenesis on the implant surface. Here, we demonstrated that the covalent grafting of the sequence (48-69) mapped on the BMP-2 growth factor (GBMP1α) significantly enhances the mineralization and gene expression of human osteoblasts. Different chemical methods were employed for covalently grafting the peptide onto 3D-printed PEEK disks: (a) the reaction between PEEK carbonyls and amino-oxy groups inserted in the peptides' N-terminal sites (oxime chemistry) and (b) the photoactivation of azido groups present in the peptides' N-terminal sites, which produces nitrene radicals able to react with PEEK surface. The peptide-induced PEEK surface modification was assessed using X-ray photoelectron measurements, while the superficial properties of the functionalized material were analyzed by means of atomic force microscopy and force spectroscopy. Live and dead assays and SEM measurements showed greater cell cover on functionalized samples than the control, without any cytotoxicity induction. Moreover, functionalization improved the rate of cell proliferation and the amount of calcium deposits, as demonstrated by the AlamarBlue™ and alizarin red results, respectively. The effects of GBMP1α on h-osteoblast gene expression were assayed using quantitative real-time polymerase chain reaction.

Digital database for nasal prosthesis design with a 3D morphable face model approach.

Designing nasal prostheses can be challenging because of the unpaired nature of the facial feature, especially in patients lacking preoperative information. Various nose model databases have been developed as a helpful starting point for the computer-aided design of nasal prostheses, but these do not appear to be readily accessible. Therefore, an open-access digital database of nose models has been generated based on a 3-dimensional (3D) morphable face model approach. This article describes the generation of the database, highlights steps for designing a nasal prosthesis, and points readers to the database for future clinical application and research.

Bioactive PEEK: Surface Enrichment of Vitronectin-Derived Adhesive Peptides.

Polyetheretherketone (PEEK) is a thermoplastic polymer that has been recently employed for bone tissue engineering as a result of its biocompatibility and mechanical properties being comparable to human bone. PEEK, however, is a bio-inert material and, when implanted, does not interact with the host tissues, resulting in poor integration. In this work, the surfaces of 3D-printed PEEK disks were functionalized with: (i) an adhesive peptide reproducing [351-359] h-Vitronectin sequence (HVP) and (ii) HVP retro-inverted dimer (D2HVP), that combines the bioactivity of the native sequence (HVP) with the stability toward proteolytic degradation. Both sequences were designed to be anchored to the polymer surface through specific covalent bonds via oxime chemistry. All functionalized PEEK samples were characterized by Water Contact Angle (WCA) measurements, Atomic Force Microscopy (AFM), and X-ray Photoelectron Spectroscopy (XPS) to confirm the peptide enrichment. The biological results showed that both peptides were able to increase cell proliferation at 3 and 21 days. D2HVP functionalized PEEK resulted in an enhanced proliferation across all time points investigated with higher calcium deposition and more elongated cell morphology.

Continuously perfusable, customisable, and matrix-free vasculature on a chip platform.

Creating vascularised cellular environments in vitro is a current challenge in tissue engineering and a bottleneck towards developing functional stem cell-derived microtissues for regenerative medicine and basic investigations. Here we have developed a new workflow to manufacture vasculature on chip (VoC) systems efficiently, quickly, and inexpensively. We have employed 3D printing for fast-prototyping of bespoke VoC and coupled them with a refined organotypic culture system (OVAA) to grow patent capillaries in vitro using tissue-specific endothelial and stromal cells. Furthermore, we have designed and implemented a pocket-size flow driver to establish physiologic perfusive flow throughout our VoC-OVAA with minimal medium use and waste. Using our platform, we have created vascularised microtissues and perfused them at physiologic flow rates for extended time (>2 weeks) observing flow-dependent vascular remodelling. Overall, we present for the first time a scalable and customisable system to grow vascularised and perfusable microtissues, a key initial step to grow mature and functional tissues in vitro. We envision that this technology will empower fast prototyping and validation of increasingly biomimetic in vitro systems, including interconnected multi-tissue systems.

A custom nasal obturator for velopharyngeal dysfunction: A dental technique.

Removable nasal obturators provide a treatment option for a range of patients presenting with velopharyngeal dysfunction without eliminating the possibility for future surgery, speech therapy, or the provision of other devices. The presented technique describes the fabrication of a 1-piece silicone nasal obturator to reduce hypernasality and nasal airflow errors without causing significant hyponasality. The obturator has minimal visibility and minimal risk of inhalation.

An automated design pipeline for transparent facial orthoses: A clinical study.

STATEMENT OF PROBLEM: Transparent facial orthoses (TFOs) are commonly used for the treatment of craniomaxillofacial trauma and burns to prevent hypertrophic and keloid scarring. A TFO is typically customized to the patient's facial contours and relies on a precise fit to ensure good rehabilitative performance. A smart method of TFO design and manufacture is needed which does not require an experienced prosthetist, allowing for rapidly produced, well-fitting TFOs. Whether the rapid application reduces the final level of patient scarring is unclear. PURPOSE: The purpose of this clinical study was to determine whether a scalable, automated design-through-manufacture pipeline for patient specific TFO fabrication would be successful. MATERIAL AND METHODS: The automated pipeline received a 3-dimensional (3D) facial scan captured from a depth sensitive mobile phone camera. The scan was cleaned, aligned, and fit to a template mesh, with a known connectivity. The resultant fitted scan was passed into an automated design pipeline, outputting a 3D printable model of a custom TFO. The TFOs were fabricated with 3D printing and were both physically and digitally evaluated to test the fidelity of a digital fit testing system. RESULTS: A total of 10 individuals were scanned with 5 different scanning technologies (STs). All scans were passed through an automated fitting pipeline and categorized into 2 groups. Each ST was digitally fitted to a ground truth scan. In this manner, a Euclidean distance map was built to the actual facial geometry for each scan. Heatmaps of 3D Euclidean distances were made for all participant faces. CONCLUSIONS: The ability to automatically design and manufacture a custom fitted TFO using commercially available 3D scanning and 3D printing technology was successfully demonstrated. After considering equipment size and operational personnel requirements, vat polymerization (VP) technology was found to be the most promising route to TFO manufacture.

DAR 16-II Primes Endothelial Cells for Angiogenesis Improving Bone Ingrowth in 3D-Printed BCP Scaffolds and Regeneration of Critically Sized Bone Defects.

Bone is a highly vascularized tissue and relies on the angiogenesis and response of cells in the immediate environmental niche at the defect site for regeneration. Hence, the ability to control angiogenesis and cellular responses during osteogenesis has important implications in tissue-engineered strategies. Self-assembling ionic-complementary peptides have received much interest as they mimic the natural extracellular matrix. Three-dimensional (3D)-printed biphasic calcium phosphate (BCP) scaffolds coated with self-assembling DAR 16-II peptide provide a support template with the ability to recruit and enhance the adhesion of cells. In vitro studies demonstrated prompt the adhesion of both human umbilical vein endothelial cells (HUVEC) and human mesenchymal stem cells (hMSC), favoring endothelial cell activation toward an angiogenic phenotype. The SEM-EDS and protein micro bicinchoninic acid (BCA) assays demonstrated the efficacy of the coating. Whole proteomic analysis of DAR 16-II-treated HUVECs demonstrated the upregulation of proteins involved in cell adhesion (HABP2), migration (AMOTL1), cytoskeletal re-arrangement (SHC1, TMOD2), immuno-modulation (AMBP, MIF), and morphogenesis (COL4A1). In vivo studies using DAR-16-II-coated scaffolds provided an architectural template, promoting cell colonization, osteogenesis, and angiogenesis. In conclusion, DAR 16-II acts as a proactive angiogenic factor when adsorbed onto BCP scaffolds and provides a simple and effective functionalization step to facilitate the translation of tailored 3D-printed BCP scaffolds for clinical applications.

Assessing biocompatibility & mechanical testing of 3D-printed PEEK versus milled PEEK.

Objectives: To compare mechanical properties of 3D-printed and milled poly-ether-ether-ketone (PEEK) materials. To define post-production treatments to enhance biocompatibility of 3D-printed PEEK. Methods: Standardised PEEK samples were produced via milling and fused-deposition-modelling 3D-printing. To evaluate mechanical properties, tensile strength, maximum flexural strength, fracture toughness, and micro-hardness were measured.3D printed samples were sandblasted with 50 or 125 µm aluminium oxide beads to increase biocompatibility.Scanning electron microscopy (SEM) evaluated microstructure of 3D-printed and sandblasted samples, estimating surface roughness at scales from 1mm-1µm.Cell adhesion on 3D printed and sandblasted materials was evaluated by culturing primary human endothelial cells and osteoblasts (HUVEC, HOBS) and evaluating cell growth over 48 h. Results: 3D printed materials had lower tensile strength, flexural strength, and fracture toughness, but higher micro-hardness.SEM analysis of 3D-printed surfaces showed sandblasting with 125 and 50 µm silica particles removed printing defects and created roughened surfaces for increased HUVEC and HOBs uniform cell adhesion and distribution. No cytotoxicity was observed over a 48h period, and all cells demonstrated >95% viability. Clinical significance: 3D-printing of PEEK is an emerging technology with clear advantages over milling in maxillofacial implant production. Nonetheless, this manufacturing modality may produce 3D printed PEEK devices with lower mechanical resistance parameters compared to milled PEEK but with values compatible with natural bone. PEEK has poor osteoconductivity and ability to osseointegrate. Sandblasting is an inexpensive modality to remove irregular surface defects and create uniform micro-rough surfaces supporting cell attachment and potentially enhancing integration of PEEK implants with host tissue.

A feasible route for the design and manufacture of customised respiratory protection through digital facial capture.

The World Health Organisation has called for a 40% increase in personal protective equipment manufacturing worldwide, recognising that frontline workers need effective protection during the COVID-19 pandemic. Current devices suffer from high fit-failure rates leaving significant proportions of users exposed to risk of viral infection. Driven by non-contact, portable, and widely available 3D scanning technologies, a workflow is presented whereby a user's face is rapidly categorised using relevant facial parameters. Device design is then directed down either a semi-customised or fully-customised route. Semi-customised designs use the extracted eye-to-chin distance to categorise users in to pre-determined size brackets established via a cohort of 200 participants encompassing 87.5% of the cohort. The user's nasal profile is approximated to a Gaussian curve to further refine the selection in to one of three subsets. Flexible silicone provides the facial interface accommodating minor mismatches between true nasal profile and the approximation, maintaining a good seal in this challenging region. Critically, users with outlying facial parameters are flagged for the fully-customised route whereby the silicone interface is mapped to 3D scan data. These two approaches allow for large scale manufacture of a limited number of design variations, currently nine through the semi-customised approach, whilst ensuring effective device fit. Furthermore, labour-intensive fully-customised designs are targeted as those users who will most greatly benefit. By encompassing both approaches, the presented workflow balances manufacturing scale-up feasibility with the diverse range of users to provide well-fitting devices as widely as possible. Novel flow visualisation on a model face is presented alongside qualitative fit-testing of prototype devices to support the workflow methodology.

Outcome measures in facial prosthesis research: A systematic review.

STATEMENT OF PROBLEM: Facial prosthesis research uses a wide variety of outcome measures, which results in challenges when comparing the effectiveness of interventions among studies. Consensus is lacking regarding the most appropriate and meaningful outcome measures to use in facial prosthesis research to capture important perspectives. PURPOSE: The purpose of the systematic review was to identify and synthesize outcome measures used in facial prosthesis research. MATERIAL AND METHODS: Electronic searches were performed in 11 databases (including nonpeer-reviewed literature). The citations were searched, and expert societies were contacted to identify additional studies. Inclusion criteria comprised studies of participants with facial defects who required or had received prosthetic rehabilitation with an external facial prosthesis. Exclusion criteria comprised participants with ocular prostheses, case reports, case series with fewer than 5 participants, laboratory-based studies, and studies published before 1980. Study selection was performed independently by 2 reviewers. Discrepancies were resolved through discussion or by a third reviewer. Outcome measures were synthesized with a categorization approach based on the perspective, theme, and subtheme of the outcome measures. Quality assessment was performed with an appraisal tool that enabled evaluation of studies with diverse designs. RESULTS: Database searching identified 13 058 records, and 7406 remained after duplications were removed. After initial screening, 189 potentially relevant records remained, and 186 full texts were located (98% retrieval rate). After full-text screening, 124 records were excluded. Citation searches and contact with expert societies identified 4 further records. In total, 69 articles (grouped into 65 studies) were included. Studies were categorized as per the perspective of their outcome measures, with the following findings: patient-reported (74% of studies), clinical indicators (34%), clinician-reported (8%), multiple viewpoints (6%), and independent observer-reported (3%). Patient-reported outcome measures included tools to assess satisfaction, quality of life, and psychologic health. Variability in the choice of outcome measures was evident among the studies, with many self-designed, unvalidated, condition-specific questionnaires reported. A greater number of outcome measure themes emerged over time; themes such as service delivery and health state utility have recently been evaluated. CONCLUSIONS: Over the past 40 years, facial prosthesis research has focused on patient-reported outcome measures. Outcome measures relating to other perspectives have been used less frequently, although new themes appear to be emerging in the literature. Future research should use outcome measures with appropriate measurement properties for use with facial prosthetics.

Volume Assessment of the Effect of Obturators on Facial Form Following Surgery for Head and Neck Cancer Using Stereophotogrammetry.

PURPOSE: To determine if stereophotogrammetry could be used to determine the effects of obturators on facial contour in relation to the measurement of facial volumes. MATERIALS AND METHODS: Stereophotogrammetry images were recorded from 20 subjects with and without their obturators in place. These were converted into a stereolithographic format and overlaid. Registrations were made using the tissues on the normal areas of the face. Difference images were created, enabling surface areas and volumes to be calculated. To assess repeatability of measurement, 2 readings were recorded on each of 2 separate registrations. Data analysis between the sets of readings used correlation coefficients and paired t-tests. Coefficients of repeatability were also calculated. RESULTS: A comparison of readings for the surface areas showed the method of measurement was repeatable with no significant differences between the 2 repeated readings for registration 1 (p = 0.977, coefficient of repeatability = 101 mm2 ), registration 2 (p = 0.085, coefficient of repeatability = 106 mm2 ), and the mean of the two readings for registration 1 compared with registration 2 (p = 0.355, coefficient of repeatability = 103 mm2 ). Similar results were found for the volume measurements with no significant differences between the repeated readings for registration 1 (p = 0.862, coefficient of repeatability = 229 mm3 ), registration 2 (p = 0.200, coefficient of repeatability = 209 mm3 ), and the mean of the 2 readings for registration 1 compared with those for registration 2 (p = 0.131, coefficient of repeatability 339 mm3 ). There was a statistically significant range of volumes that appeared to have been restored by the obturators (p < 0.0005). CONCLUSIONS: Stereophotogrammetry is reliable in assessing the effects of obturators on facial form. In the sample of subjects, obturators generally appeared to be effective in supporting facial tissues following surgical resections of the maxilla and therefore contribute in some degree to the restoration of facial appearance.

Suitability of a Mobile Phone Colorimeter Application for Use as an Objective Aid when Matching Skin Color during the Fabrication of a Maxillofacial Prosthesis.

PURPOSE: Color matching a facial prosthesis to human skin is very challenging. Colorimeters aid this process by adding objectivity to what is an otherwise subjective procedure. Mobile phone colorimeter applications offer a less expensive and widely available alternative to dedicated colorimeter devices for color measurement. There is a lack of evidence in the literature regarding the suitability of mobile phone colorimeter applications for the development of silicone shades for facial prosthetics. The purpose of this study is to determine the suitability of a mobile phone colorimeter application for matching natural skin colors during the fabrication of maxillofacial prostheses. MATERIALS AND METHODS: Ten pigmented maxillofacial silicone elastomer swatches were fabricated to mimic a range of human skin tones. Color measurements of these swatches were recorded using a test instrument-the mobile phone colorimeter application (RGB Colorimeter) and a reference instrument-the commercially available skin color measurement device e-skin spectrocolorimeter. Comparisons in trueness and precision of the color measurements were made using previously described methods. Data analysis was performed on the recorded results for each of the parameters at three distances (25, 30, and 35 mm) of the test instrument from the target against both a black and a white background. RESULTS: The trueness of the mobile phone colorimeter application relative to the colorimeter device varied depending on the distance from the target and the background color. The relative trueness of the color difference measurements fell just within the documented upper threshold of acceptable limits of color difference (∆E 3.0 - 4.4). The calculated precision of the CIE L*a*b* and ∆E measurements of the mobile phone colorimeter application was good, with the latter being well within the documented acceptable limits. CONCLUSIONS: A mobile phone colorimeter application would be a suitable aid in objectifying the process of color matching a silicone maxillofacial prosthesis. Further investigation into image calibration to improve trueness and the control of variables such as background noise, uniformity of illumination, and measuring distance is required.

Color stability of nonpigmented and pigmented maxillofacial silicone elastomer exposed to 3 different environments.

STATEMENT OF PROBLEM: The color degradation of maxillofacial prostheses in clinical service requires their frequent renewal. How different materials compare is unclear. PURPOSE: The purpose of this in vitro study was to investigate the color stability of a nonpigmented and pigmented maxillofacial silicone when stored in darkness and exposed to accelerated aging in a weathering chamber and natural outdoor weathering. MATERIAL AND METHODS: M511 elastomer was colored with Spectromatch Pro colorants, stored in darkness, and exposed to accelerated aging and natural outdoor weathering for 1500 hours. Test groups included nonpigmented specimens (n=18), individually pigmented specimens (n=90), and Caucasian skin tone-colored specimens (n=18). The CIELab values of the test specimens were measured using the CM-2600d spectrophotometer (Konica Minolta Sensing) at base line (0 hours) and then every 100 hours up to 1500 hours of aging. Color changes (ΔE) were calculated based on the recorded CIELab values. All data were analyzed by using linear mixed models and the Sídák multiple comparison of means test (α=.05). RESULTS: A significant effect of time was found on the ΔE of all test specimens in all environments (P=.001). All pigmented M511 specimens demonstrated good color stability with maximum ΔE below the acceptability threshold of 2 ΔE when stored in darkness and exposed to outdoor weathering. However, nonpigmented specimens crossed this acceptability threshold when exposed to outdoor weathering with maximum ΔE values of 3.65. The greatest color changes were observed for all specimens when exposed to accelerated aging and most exceeded the acceptability threshold. Nonpigmented (ΔE, 4.86) and Indian yellow (ΔE, 5.20) demonstrated the highest color changes after 1500 hours. CONCLUSIONS: All environments resulted in visible color changes of nonpigmented and pigmented M511 elastomer. The lowest ΔE values were observed for specimens stored in darkness and the greatest for specimens exposed to accelerated aging. The organic pigment Logwood maroon demonstrated the best color stability with maximum ΔE values below the perceptibility threshold (PT) of 1 ΔE.

Development of a 3D printable maxillofacial silicone: Part II. Optimization of moderator and thixotropic agent.

STATEMENT OF PROBLEM: Conventionally, maxillofacial prostheses are fabricated by hand carving the missing anatomic defect in wax and creating a mold into which pigmented silicone elastomer is placed. Digital technologies such as computer numerical control milling and 3-dimensional (3D) printing have been used to prepare molds, directly or indirectly, into which a biocompatible pigmented silicone elastomer can be placed. PURPOSE: The purpose of this in vitro study was to develop a silicone elastomer that could be 3D printed directly without a mold to create facial or body prostheses by varying its composition. MATERIAL AND METHODS: The room temperature vulcanizing silicone composition was divided into 2 components which were mixed 1:1 to initiate polymerization in the printer before printing began. Different types of moderators and thixotropic agents were used, and the base composition was varied to obtain 11 formulations. The specimens were printed and polymerized from these formulations and tested for tear and tensile strength and hardness. Ten readings of the specimens were recorded for tear and tensile strength and 6 for hardness. Results were analyzed using ANOVA (α=.05). Visual assessment of uncured printed specimens was undertaken for 5 formulations to assess any differences in their ability to hold their shape after printing. RESULTS: The tear and tensile strength of the 11 formulations with varying moderators, thixotropic agents, and base compositions were statistically similar to each other (P>.05). Five of 11 formulations were chosen for the visual assessment as they had sufficient thixotropic agent to avoid slumping while printing. The specimens showed varied slumping behavior until they polymerized. The filler content was increased in the selected formulation, and the tear and tensile strength of the formulation was increased to 6.138 kNm-1 and 3.836 MPa; these increases were comparable to those of commercial silicones currently used for the fabrication of facial prostheses. CONCLUSIONS: The optimum combination of mechanical properties implies the use of one of the formulations as a suitable material for the 3D printing of facial prostheses.

Evaluation of the effect of ultraviolet stabilizers on the change in color of pigmented silicone elastomer: An in vitro study.

AIM AND OBJECTIVE: To compare and evaluate the effect of ultraviolet (UV) stabilizers (Chimassorb 81 and Uvinul 5050) on the color change of pigmented elastomer. MATERIALS AND METHODS: Two pigments - Red (P112 Brilliant Red) and Yellow (P106 Yellow) and two UV stabilizers Chimassorb 81 and Uvinul 5050 were studied. A total of six groups of 10 samples each were fabricated using a combination of the above colors and stabilizers: Group A1 - Red control, Group A2 - Red + Chimassorb 81, Group A3 - Red + Uvinul 5050. Group B1 - Yellow control, Group B2 - Yellow + Chimassorb 81, Group B3 - Yellow + Uvinul 5050. All samples were subjected to ageing in an accelerated weathering chamber (Weather-Ometer). Color values L, a, and b were measured at 500 and 1000 h for all samples before and after weathering and change in color (Delta E) was calculated. RESULTS: All groups showed a significant color change. At 500 h, Chimassorb 81 showed a statistically significant lesser change in both colors (red - 3.66 and yellow - 2.8) compared to their control groups (red - 5.19 and yellow - 4.9). At 1000 h, both UV stabilizers showed lesser color change (A2 - 5.49, B2 - 4.28, A3 - 7.47 and B3 - 4.09) as compared to their respective control groups (A1 - 9.57 and B1 - 5.91). Overall, the change in the color with Group A was more than Group B. CONCLUSION: Addition of UV stabilizers helped the reduction of color change. Chimassorb 81 showed a greater reduction in color change in both colors consistently at 500 and 1000 h.

Development of a 3D printable maxillofacial silicone: Part I. Optimization of polydimethylsiloxane chains and cross-linker concentration.

STATEMENT OF PROBLEM: Conventionally, maxillofacial prostheses are fabricated by hand carving the missing anatomic defect in wax and creating a mold into which pigmented silicone elastomer is placed. Digital technologies such as computer numerical control (CNC) milling and 3-dimensional (3D) printing have been used to prepare molds directly or indirectly into which a biocompatible pigmented silicone elastomer is placed. PURPOSE: The purpose of this in vitro study was to develop a silicone elastomer by varying composition that could eventually be 3D printed directly without a mold to create facial/body prostheses. MATERIAL AND METHODS: The silicone was composed of polydimethylsiloxane (PDMS), filler, catalyst, and cross-linker. Four types of base silicone polymers were prepared with different PDMS molecular weight combinations with long, medium, and short chain length PDMS. The effect of the cross-linker (2.5% to 12.5%) content in these bases was assessed for the effect upon the mechanical properties of the elastomer. Ten readings were made for each formulation, and differences in the means were evaluated with a 2-way ANOVA (α=.05). RESULTS: Variations in silicone composition resulted in hardness from 6.8 to 28.5 durometer, tensile strength from 0.720 to 3.524 kNm-1 and tear strength from 0.954 to 8.484 MPa. Significant differences were observed among all formulations (P<.05). These formulations have mechanical properties comparable with the commercial silicones currently used for the fabrication of facial prostheses. The formulation with 5% cross-linker content and high content of long-chain PDMS chains with optimum mechanical properties was chosen for further development. CONCLUSIONS: The optimum combination of mechanical properties implies the use of one of these formulations for further evaluation in a 3D printer capable of actively mixing and extruding 2-component, room temperature vulcanization silicone.

The effect of model inclination during fabrication on mouthguard calliper-measured and CT scan-assessed thickness.

AIM: Excessive material thinning has been observed in the production of custom-made mouthguards in a number of studies, due to production anomalies that may lead to such thinning. This study investigated thinning material patterns of custom-made mouthguards when the anterior angulation of dental model was increased during the thermoforming process. MATERIALS AND METHODS: A total of 60 samples of mouthguard blanks were thermoformed on identical maxillary models under four anterior inclination conditions (n = 4 × 15): control 0, 15, 30 and 45°. Each mouthguard sample was measured, using an electronic calliper gauge at three anatomical points (anterior labial sulcus, posterior occlusion and posterior lingual). Mouthguards were then CT scanned to give a visual representation of the surface thickness. RESULTS: Data showed a significant difference (P < 0.005) in the anterior mouthguard thickness between the four levels of anterior inclination, with the 45° inclination producing the thickest mouthguards, increasing the mean anterior thickness by 75% (2.8 mm, SD: 0.16) from the model on a flat plane (1.6 mm, SD: 0.34). Anterior model inclination of 30 and 45° inclinations increased consistencies between the thickest and thinnest mouthguards in the anterior region of these sample groups. CONCLUSION: This study highlights the importance of standardizing the thermoforming process, as this has a significant effect on the quality and material distribution of the resultant product. In particular, greater model inclination is advised as this optimizes the thickness of the anterior sulcus of the mouthguard which may be more prominently at risk from sport-related impact.

An investigation into the relationship between thickness variations and manufacturing techniques of mouthguards.

BACKGROUND: The aim of this study was to measure the finished thickness of a single identical 4-mm EVA mouthguard model from a large fabricated sample group and to evaluate the degree of material thinning and variations during the fabrication process. MATERIALS AND METHODS: Twenty boxes were distributed to dental technician participants, each containing five duplicated dental models (n = 100), alongside 5 × 4 mm mouthguard blanks and a questionnaire. The mouthguards were measured using electronic callipers (resolution: ±0.01 mm) at three specific points. The five thickest and thinnest mouthguards were examined using a CT scanner to describe the surface typography unique to each mouthguard, highlighting dimensional thinning patterns during the fabrication process. RESULTS: Of the three measurement points, the anterior sulcus point of the mouthguard showed a significant degree of variation (up to 34% coefficient of variation), in finished mouthguard thickness between individuals. The mean thickness of the mouthguards in the anterior region was 1.62 ± 0.38 mm with a range of 0.77-2.80 mm. This variation was also evident in the occlusion and posterior lingual regions but to a lesser extent (up to 12.2% and 9.8% variations, respectively). CONCLUSION: This study highlights variability in the finished thickness of the mouthguards especially in the anterior sulcus region measurement point, both within and between individuals. At the anterior region measurement point of the mouthguard, the mean thickness was 1.62 mm, equating to an overall material thinning of 59.5% when using a single 4-mm EVA blank. This degree of thinning is comparative to previous single operator research studies.