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.

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.

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.

Development of a morphing technique for predicting the position and size of an artificial ear in hemifacial microsomia patients.

PURPOSE: People with hemifacial microsomia may be missing an ear on the affected side of the face. The principal aim of the study was to develop a morphing technique and to determine whether it could be used to appropriately position an artificial ear, as well as to give an indication of prosthesis size in comparison with the natural ear. Comparisons also were made between the artificial ears being worn by the patients with their natural ears. MATERIALS AND METHODS: Data from stereophotogrammetry images of the faces of 10 people were converted into stereolithographic format. Anthropometric points on the face and ear of the unaffected side were plotted. By a process of scaling, the distance between facial landmarks on the unaffected side was estimated for the affected side so as to identify where the morphed ear would be positioned once generated. RESULTS: Generally, the morphed ears appeared to be in acceptable positions. There was a statistically significant difference between the position of the morphed and natural ears (P = .011), as well as the artificial and natural ears (P = .001), but this was unlikely to have any clinical implications. There were no significant differences among the sizes of the natural, morphed, and artificial ears (P = .072). CONCLUSIONS: Morphing appears to offer a more precise way of planning the positioning and construction of an artificial ear on patients with hemifacial microsomia than traditional methods. Differences in facial shape on either side of the face may impact on the process. This requires further study.

A comparison of three methods to evaluate the position of an artificial ear on the deficient side of the face from a three-dimensional surface scan of patients with hemifacial microsomia.

PURPOSE: Patients with hemifacial microsomia may have a missing ear on the deficient side of the face. The fabrication of an ear for such individuals usually has been accomplished by directly measuring the ear on the normal side to construct a prosthesis based on these dimensions, and the positioning has been, to a large extent, primarily operator-dependent. The aim of the present study was to compare three methods, developed from the identification of landmarks plotted on three-dimensional surface scans, to evaluate the position of an artificial ear on the deficient side of the face compared with the position of the natural ear on the normally developed side. MATERIALS AND METHODS: Laser scans were undertaken of the faces of 14 subjects with hemifacial microsomia. Landmarks on the ear and face on the normal side were identified. Three methods of mirroring the normal ear on the deficient side of the face were investigated, which used either facial landmarks from the orbital area or a zero reference point generated from the intersection of three orthogonal planes on a frame of reference. To assess the methods, landmarks were identified on the ear situated on the normal side as well as on the face. These landmarks yielded paired dimensional measurements that could be compared between the normal and deficient sides. Mean differences and 95% confidence intervals were calculated. RESULTS: It was possible to mirror the normal ear image on to the deficient side of the face using all three methods. Generally only small differences between the dimensional measurements on the normal and deficient sides were observed. However, two-way analysis of variance revealed statistically significant differences between the three methods (P = .005). CONCLUSIONS: The method of mirroring using the outer canthi was found to result in the smallest dimensional differences between the anthropometric points on the ear and face between the normally developed and deficient sides. However, the effects of the deformity can result in limitations in relation to achieving a precise alignment of the ear to the facial tissues. This requires further study.

Development of a stereophotogrammetry technique to assess facial change following surgery for head and neck cancer.

A stereophotogrammetry technique is described that can be used to map the face following surgery for head and neck cancer. It enables the effects of obturators on facial form to be assessed and may have a wide variety of applications. Int J Prosthodont 2011;24:342-344.

Coloration of silicone prostheses: technology versus clinical perception. Is there a difference? Part 2, clinical evaluation of a pilot study.

PURPOSE: The aim of this investigation was to explore the relationship between an objective computer measurement of color difference (ΔE) and subjective clinical opinion of a "good" color match between silicone samples and skin. MATERIALS AND METHODS: In Part 1 of this study, silicone samples were colored to match the skin of 19 African-Canadian subjects based on spectrophotometric measurements and pigment formulae determined by computerized color formulation software. Four iterative samples were prepared for each subject; a ΔE value was recorded for each sample to represent the color difference between the silicone sample and skin. In this article, Part 2, five judges independently assessed the color match of the silicone samples to the skin of each of the subjects. Skin and silicone samples were rated on a five-point scale as a measure of "color match." A multivariate analysis was used to determine relationships between judges' assessments and the following variables: color difference between silicone and skin (ΔE), pigment loading, and skin characteristics (L*, a*, b*). RESULTS: There was a positive correlation between judges' scores and low ΔE values for the first two samples. All judges rated the first sample a poorer color match than the fourth sample (p < 0.015). The third sample performed better overall according to judges. Increased pigment loading in the fourth sample resulted in poorer scores. A trend was observed in pigment selection based on skin values, though no significant relationships were determined. CONCLUSION: Spectrophotometry and computerized color formulation technology offer an enhanced understanding of color for its artistic application in facial prosthetic treatment. While some correlation between the objective and subjective assessments of color match exist, it is not a simple relationship. Further study is required to better understand the relationship between technology and clinical perception, specifically in objective and subjective assessments of a "good" color match of silicone to skin.

A comparison of prosthetic ear models created from data captured by computerized tomography, magnetic resonance imaging, and laser scanning.

PURPOSE: To compare the dimensional measurements and surface topography of stereolithographic models generated from computerized tomography (CT), magnetic resonance imaging (MRI), and laser scanning (LS) data with the same subjects' natural ears and ear casts. MATERIALS AND METHODS: Stereolithographic models were manufactured from images of the subjects' ears and ear casts recorded by CT, MRI, and LS, and dimensional measurements were compared. In the second part of the study, all stereolithographic models were CT scanned and reconstructed in an STL file format. A comparison of the surface topography of the CT, MRI, and LS model ears was made. RESULTS: Intraclass correlation coefficients indicated that dimensions could be reliably measured on the CT, MRI, and LS stereolithographic models. A 2-way analysis of variance revealed no statistical differences between the various sources of data (P = .991). The smallest differences of surface topography were observed on the MRI/CT superimpositions. CONCLUSION: The dimensional measurements on the stereolithographic models were similar to those from the original source. Only small differences were apparent between the surface topography of the CT, MRI, and LS models. MRI may be particularly appropriate to fabricate a prosthesis because it involves no radiation for the patient and internal form can be reproduced. The use of this technique in clinical practice requires further study.

A comparison between computerized tomography, magnetic resonance imaging, and laser scanning for capturing 3-dimensional data from a natural ear to aid rehabilitation.

PURPOSE: To compare dimensional measurements on computer images generated from data captured digitally by 3 different methods to those obtained directly from natural ears and ear casts, so as to determine the optimal method of creating a computer-generated ear image. MATERIALS AND METHODS: Magnetic resonance imaging (MRI) was used to obtain 3-dimensional (3D) data images of the normal ears of 14 subjects. Computerized tomography (CT) and laser scanning (LS) were used to obtain 3D data images from stone casts of the same ears. Dimensional measurements were recorded on 2 occasions between anthropometric landmarks on the subjects' natural ears, casts of the ears, and reconstructed ear images obtained by CT, MRI, and LS. The intraclass correlation coefficients and coefficients of repeatability were calculated. The means of the 2 measurements for each of the dimensions were analyzed using 2-way analysis of variance to determine whether there were differences between the methods of data collection. RESULTS: The intraclass correlation coefficients indicated that dimensions could be reliably measured on the natural ears, casts, and CT, MRI, and LS images. The coefficients of repeatability were all of a small magnitude in relation to the overall dimensions studied. No statistical differences existed between the various sources of data (P = .866) (i.e., direct, cast, CT, MRI, and LS). CONCLUSION: The 3 methods of imaging have generally resulted in dimensional measurements on the reconstructed images that are similar to those of the original source. These are considered appropriate for manufacturing 3D models that can be used to fabricate a prosthesis. However, other factors may also be important, such as shape, contour, and internal form, and these require further investigation.

A comparison between computerized tomography, magnetic resonance imaging, and laser scanning for capturing 3-dimensional data from an object of standard form.

PURPOSE: The study's aim was to compare dimensional measurements on computer images generated from data captured digitally by 3 different methods of the surfaces of a plastic cube of known form to those obtained directly from the cube itself. MATERIALS AND METHODS: Three-dimensional images were reconstructed of a plastic cube obtained by computerized tomography (CT), magnetic resonance imaging (MRI), and laser scanning. Digital calipers were used to record dimensional measurements between the opposing faces of the plastic cube. Similar dimensional measurements were recorded between the cube faces on each of the reconstructed images. The data were analyzed using a 2-way ANOVA to determine whether there were differences between dimensional measurements on the computer images generated from the digitization of the cube surfaces by the different techniques, and the direct measurement of the cube itself. RESULTS: A significant effect of how the measurements were taken (ie, direct, CT, MRI, and laser scanning) on the overall variation of dimensional measurement (P < .0005) was observed. Post hoc tests (Bonferroni) revealed that these differences were due principally to differences between the laser-scanned images compared to other sources (ie, direct, CT, and MRI). The magnitude of these differences was very small, up to a maximum mean difference of 0.71 mm (Cl +/- 0.037 mm). CONCLUSION: All 3 methods of imaging would be of value in further studies, not only for the fabrication of complex shapes such as prosthetic ears, but also for other facial prostheses.

A preliminary study to investigate the potential of plasma screen technology in small group teaching for dental undergraduates.

AIM: This preliminary study was devised to ascertain whether students considered that they had an adequate view of demonstrated procedures, while observing these directly at the workbench, or indirectly on a remote plasma screen. In addition, this study sought to identify whether the students observing remotely believed that they had been disadvantaged by the inability to question the demonstrator during the demonstration. METHODS: Seventeen students divided into two groups observed a live demonstration of a laboratory technical procedure either at the workbench, or remotely at a plasma screen with the aid of video cameras. They subsequently observed a second demonstration with the roles reversed. Questionnaires were used to obtain the students' views of their ability to see and interact with the demonstrator. RESULTS: The responses of the students observing the demonstration at the plasma screen indicated that (they felt that) they were able to see the demonstration more clearly than those observing at the workbench. Those observing at the plasma screen first, in particular indicated this. The majority of students acknowledged their inability to ask questions while observing at the plasma screen. There was overwhelming support for the idea that the plasma screen should be used to complement the demonstration at the workbench. CONCLUSION: Plasma screen technology has considerable potential as a teaching tool for small groups of students, where it can afford significantly superior views of practical procedures. The students considered that the plasma screen would be best employed to provide close-up views to supplement a live demonstration. When used remotely, the apparatus may be used more satisfactorily if videoconferencing technology is also employed to facilitate interaction with the demonstrator.