A temperature-sensitive, high-adhesion medical tape: a comparative, single-blind clinical trial.

OBJECTIVE: Medical adhesives are used to secure wound care dressings and other critical devices to the skin. While high peel-strength adhesives provide more secure skin attachment, they are difficult to remove from the skin and are correlated with medical adhesive-related skin injuries (MARSI), including skin tears, and an increased risk of infection. Lower-adhesion medical tapes may be applied to avoid MARSI, leading to dressing or device dislodgement and further medical complications. METHOD: This paper reports on the clinical testing of a new, high-adhesion medical tape, ThermoTape (University of Washington, US), designed for low skin trauma upon release. ThermoTape was benchmarked with Tegaderm (3M, US) and Kind Removal Tape (KRT) (3M, US). All three tapes were applied to both the left and right forearm of healthy volunteers and were removed 24 hours later-the right arm without applying heat and the left arm by applying a heat pack for 30 seconds before removal. Tape wear, self-reported pain (0-10 scale) and skin redness 15 minutes after removal were recorded. RESULTS: This was a 53-subject comparative, single-blind clinical trial. There were clinically and statistically significant results supporting reduced pain during removal of ThermoTape with warming, with an average 58% decrease in pain, paired with a statistically significant 45% reduction in skin redness (p<0.01 for both values). In contrast, there were statistically insignificant differences in pain and redness for removal of Tegaderm and KRT with warming. ThermoTape after warming, in comparison with Tegaderm without warming, produced a reduced pain score of >1 on the 0-10 Wong-Baker/Face pain scale, which was statistically significant (p<0.01). CONCLUSION: These results provide compelling evidence that warming ThermoTape prior to removal can reduce pain and injury when compared with standard medical tapes. This could allow for stronger attachment of wound care dressings and critical medical devices while reducing cases of MARSI.

Prototype Development of a Temperature-Sensitive High-Adhesion Medical Tape to Reduce Medical-Adhesive-Related Skin Injury and Improve Quality of Care.

Medical adhesives are used to secure wound care dressings and other critical devices to the skin. Without means of safe removal, these stronger adhesives are difficult to painlessly remove from the skin and may cause medical-adhesive-related skin injuries (MARSI), including skin tears and an increased risk of infection. Lower-adhesion medical tapes may be applied to avoid MARSI, leading to device dislodgement and further medical complications. This paper outlines the development of a high-adhesion medical tape designed for low skin trauma upon release. By warming the skin-attached tape for 10-30 s, a significant loss in adhesion was achieved. A C14/C18 copolymer was developed and combined with a selected pressure-sensitive adhesive (PSA) material. The addition of 1% C14/C18 copolymer yielded the largest temperature-responsive drop in surface adhesion. The adhesive film was characterized using AFM, and distinct nanodomains were identified on the exterior surface of the PSA. Our optimized formulation yielded 67% drop in adhesion when warmed to 45 °C, perhaps due to melting nanodomains weakening the adhesive-substrate boundary layer. Pilot clinical testing resulted in a significant decrease in pain when a heat pack was used for removal, giving an average pain reduction of 66%.

O-pH: Optical pH Monitor to Measure Dental Biofilm Acidity and Assist in Enamel Health Monitoring.

OBJECTIVE: Bacteria in the dental biofilm produceacid after consumption of carbohydrates which if left unmonitored leads to caries formation. We present O-pH, a device that can measure dental biofilm acidity and provide quantitative feedback to assist in oral health monitoring. METHOD: O-pH utilizes a ratiometric pH sensing method by capturing fluorescence of Sodium Fluorescein, an FDA approved chemical dye. The device was calibrated to a lab pH meter using buffered fluorescein solution with a correlation coefficient of 0.97. The calibration was further verified in vitro on additional buffered solution, artificial, and extracted teeth. An in vivo study on 30 pediatric subjects was performed to measure pH before (rest pH) and after (drop pH) a sugar rinse, and the resultant difference in pH (diff pH) was calculated. The study enrolled subjects with low (Post-Cleaning) and heavy (Pre-Cleaning) biofilm load, having both unhealthy/healthy surfaces. Further, we modified point-based O-pH to an image-based device using a multimode-scanning fiber endoscope (mm-SFE) and tested in vivo on one subject. RESULTS AND CONCLUSION: We found significant difference between Post-Cleaning and Pre-Cleaning group using drop pH and diff pH. Additionally, in Pre-Cleaning group, the rest and drop pH is lower at the caries surfaces compared to healthy surfaces. Similar trend was not noticed in the Post-Cleaning group. mm-SFE pH scope recorded image-based pH heatmap of a subject with an average diff pH of 1.5. SIGNIFICANCE: This work builds an optical pH prototype and presents a pioneering study for non-invasively measuring pH of dental biofilm clinically.

Optical pH measurement system using a single fluorescent dye for assessing susceptibility to dental caries (Erratum).

The erratum corrects a grant number listed in Acknowledgments section of the original article.

Effect of fluorescent and nonfluorescent glaze pastes on lithium disilicate pressed ceramic color at different thicknesses.

STATEMENT OF PROBLEM: Materials possessing fluorescent properties are assumed to emit sufficient visible light to change tooth color under daylight illumination. Fluorescent and nonfluorescent glaze pastes are available to finish the surface of a pressed lithium disilicate restoration. However, the effect of a fluorescent-glaze layer on the final color of the restoration remains unclear. PURPOSE: The purpose of this in vitro study was to measure the color dimensions of lithium disilicate glass-ceramic with different thicknesses and different surface treatments under daylight (D65) illumination conditions. MATERIAL AND METHODS: A total of 120 pressed lithium disilicate glass-ceramic disks were fabricated with 4 different thicknesses: 0.7, 1.2, 1.7, and 2.2 mm. In each thickness, 3 different subgroups were created based on the surface treatment performed (n=10): polished (NG), clear glaze (CG), and fluorescent glaze (FG). For the NG group, disks were polished with 180-, 320-, 600-, 800-, and 1400-grit SiC papers and a polishing machine. For the glazed groups, the CG and FG groups, the specimens were polished with 180-grit SiC papers and the same polishing machine. After the polishing sequence, the final thickness was verified in all groups by using digital calipers (0.5, 1.0, 1.5, and 2.0 mm). Additionally, 20 µL of clear glaze or fluorescent glaze was applied on the CG and FL groups by using an electronic positive displacement repeating pipette. The glaze layer was crystallized in a furnace according to the manufacturer recommendations. Color measurements in the CIELab coordinates were made with a spectrometer coupled to an integrating sphere and a standardized photography gray card as a background. Color difference (ΔE) values were calculated by using the CIE76 and CIEDE2000 formulas. The Shapiro-Wilk test revealed that the data were normally distributed. Two-way ANOVA and the Bonferroni test for multiple comparisons were used to analyze the data (α=.05). RESULTS: Statistically significant differences were found among the groups for the L∗, a∗, and b∗ values for the different ceramic thicknesses and surface finishing treatments evaluated (P<.001), except for the b∗ value between the FG and CG groups (P=.988). The L∗ value on the polished group was significantly higher than that on the glazed specimens, followed by the fluorescent-glazed and then by the clear-glazed specimens (P<.001). The ΔE values using the CIE76 formula varied from 0.87 to 2.76 among specimen groups and from 0.32 to 2.34 using the CIEDE2000 among the tested groups. CONCLUSIONS: Ceramic thickness and surface finishing treatment affected all color dimensions (L∗, a∗, and b∗ values) of lithium disilicate ceramic under daylight conditions. These differences resulted in a perceptible but acceptable color mismatch. The value (L∗ color dimension) of the lithium disilicate ceramic was higher on fluorescent-glazed than on not-fluorescent-glazed specimens.

Optical pH measurement system using a single fluorescent dye for assessing susceptibility to dental caries.

Sugar-rich diets and poor dental hygiene promote the formation of a biofilm (plaque) that strongly adheres to the dental enamel surface and fosters the evolution of aciduric bacteria. The acid contributes to demineralization of the exterior tooth enamel, which accelerates after the pH drops below a critical value (∼5.5) for extended time periods resulting in the need for restorative procedures. Preventative techniques to alert the dentist and caries-susceptible patients regarding vulnerability to dental decay require a clinical measure of plaque activity. Therefore, there is a need to evaluate the acid production capability of plaque deposits in the pits and fissures of occlusal and interproximal regions. A ratiometric fluorescence pH-sensing device has been developed using an FDA-approved dye and LED excitation. Fluorescein spectral profiles were collected using a spectrometer and analyzed with a spectral unmixing algorithm for calibration over the pH range of 4.5 to 7. An in vivo pilot study on human subjects was performed using a sucrose rinse to accelerate bacterial metabolism and to measure the time-dependent drop in pH. The optical system is relatively immune to confounding factors such as photobleaching, dye concentration, and variation in excitation intensity associated with earlier dye-based pH measurement techniques.

Dental pH Opti-Wand (DpOW): measuring oral acidity to guide enamel preservation.

Undetected caries can lead to painful cavities and surgical restorations. Lack of proper detection tools makes caries prevention dependent on dentist's expertise and presents obstacles in oral health monitoring. To overcome this problem, we have developed a new approach to predict early stages of enamel demineralization caused by oral bacteria. These bacteria metabolize sugars in our food and produce organic acids that lead to cavities. Measuring the acidity level can help predict early stages of tooth decay. pH paper or pH electrodes can be used to monitor acidity, but neither are able to track pH levels in all dental locations. Our device, DpOW, is a noncontact optics-based pH device that uses changes in the spectral fluorescence of FDA allowed fluorescein dye to measure acidity levels in difficult to access dental locations such as occlusal fissures. A prototype has been tested over a wide pH range (7.12 to 3.89) and shown to track the change in pH with 0.94 correlation coefficient.

Optical Characterization of Neurosurgical Operating Microscopes: Quantitative Fluorescence and Assessment of PpIX Photobleaching.

Protoporphyrin IX (PpIX) induced by 5-aminolevulinic acid (5-ALA) is increasingly used as a fluorescent marker for fluorescence-guided resection of malignant gliomas. Understanding how the properties of the excitation light source and PpIX fluorescence interact with the surgical microscope is critical for effective use of the fluorescence-guided tumor resection technique. In this study, we performed a detailed assessment of the intensity of the emitted blue light and white light and the light beam profile of clinical grade operating microscopes used for PpIX visualization. These measurements revealed both recognized fluorescence photobleaching limitations and unrecognized limitations that may alter quantitative observations of PpIX fluorescence obtained with the operating microscope with potential impact on research and clinical uses. We also evaluated the optical properties of a photostable fluorescent standard with an excitation-emission profile similar to PpIX. In addition, we measured the time-dependent dynamics of 5-ALA-induced PpIX fluorescence in an animal glioma model. Finally, we developed a ratiometric method for quantification of the PpIX fluorescence that uses the photostable fluorescent standard to normalize PpIX fluorescence intensity. This method increases accuracy and allows reproducible and direct comparability of the measurements from multiple samples.

Scanning Fiber Endoscope Improves Detection of 5-Aminolevulinic Acid-Induced Protoporphyrin IX Fluorescence at the Boundary of Infiltrative Glioma.

OBJECTIVE: Fluorescence-guided surgery with protoporphyrin IX (PpIX) as a photodiagnostic marker is gaining acceptance for resection of malignant gliomas. Current wide-field imaging technologies do not have sufficient sensitivity to detect low PpIX concentrations. We evaluated a scanning fiber endoscope (SFE) for detection of PpIX fluorescence in gliomas and compared it to an operating microscope (OPMI) equipped with a fluorescence module and to a benchtop confocal laser scanning microscope (CLSM). METHODS: 5-Aminolevulinic acid-induced PpIX fluorescence was assessed in GL261-Luc2 cells in vitro and in vivo after implantation in mouse brains, at an invading glioma growth stage, simulating residual tumor. Intraoperative fluorescence of high and low PpIX concentrations in normal brain and tumor regions with SFE, OPMI, CLSM, and histopathology were compared. RESULTS: SFE imaging of PpIX correlated to CLSM at the cellular level. PpIX accumulated in normal brain cells but significantly less than in glioma cells. SFE was more sensitive to accumulated PpIX in fluorescent brain areas than OPMI (P < 0.01) and dramatically increased imaging time (>6×) before tumor-to-background contrast was diminished because of photobleaching. CONCLUSIONS: SFE provides new endoscopic capabilities to view PpIX-fluorescing tumor regions at cellular resolution. SFE may allow accurate imaging of 5-aminolevulinic acid labeling of gliomas and other tumor types when current detection techniques have failed to provide reliable visualization. SFE was significantly more sensitive than OPMI to low PpIX concentrations, which is relevant to identifying the leading edge or metastasizing cells of malignant glioma or to treating low-grade gliomas. This new application has the potential to benefit surgical outcomes.

Target-to-background enhancement in multispectral endoscopy with background autofluorescence mitigation for quantitative molecular imaging.

Fluorescence molecular imaging with exogenous probes improves specificity for the detection of diseased tissues by targeting unambiguous molecular signatures. Additionally, increased diagnostic sensitivity is expected with the application of multiple molecular probes. We developed a real-time multispectral fluorescence-reflectance scanning fiber endoscope (SFE) for wide-field molecular imaging of fluorescent dye-labeled molecular probes at nanomolar detection levels. Concurrent multichannel imaging with the wide-field SFE also allows for real-time mitigation of the background autofluorescence (AF) signal, especially when fluorescein, a U.S. Food and Drug Administration approved dye, is used as the target fluorophore. Quantitative tissue AF was measured for the ex vivo porcine esophagus and murine brain tissues across the visible and nearinfrared spectra. AF signals were then transferred to the unit of targeted fluorophore concentration to evaluate the SFE detection sensitivity for sodium fluorescein and cyanine. Next, we demonstrated a real-time AF mitigation algorithm on a tissue phantom, which featured molecular probe targeted cells of high-grade dysplasia on a substrate containing AF species. The target-to-background ratio was enhanced by more than one order of magnitude when applying the real-time AF mitigation algorithm. Furthermore, a quantitative estimate of the fluorescein photodegradation (photobleaching) rate was evaluated and shown to be insignificant under the illumination conditions of SFE. In summary, the multichannel laser-based flexible SFE has demonstrated the capability to provide sufficient detection sensitivity, image contrast, and quantitative target intensity information for detecting small precancerous lesions in vivo.

Trimodal detection of early childhood caries using laser light scanning and fluorescence spectroscopy: clinical prototype.

There is currently a need for a safe and effective way to detect and diagnose early stages of childhood caries. A multimodal optical clinical prototype for diagnosing caries demineralization in vivo has been developed. The device can be used to quickly image and screen for any signs of demineralized enamel by obtaining high-resolution and high-contrast surface images using a 405-nm laser as the illumination source, as well as obtaining autofluorescence and bacterial fluorescence images. When a suspicious region of demineralization is located, the device also performs dual laser fluorescence spectroscopy using 405- and 532-nm laser excitation. An autofluorescence ratio of the two excitation lasers is computed and used to quantitatively diagnose enamel health. The device was tested on five patients in vivo as well as on 28 extracted teeth with clinically diagnosed carious lesions. The device was able to provide detailed images that highlighted the lesions identified by the clinicians. The autofluorescence spectroscopic ratios obtained from the extracted teeth successfully quantitatively discriminated between sound and demineralized enamel.

Mitigating fluorescence spectral overlap in wide-field endoscopic imaging.

The number of molecular species suitable for multispectral fluorescence imaging is limited due to the overlap of the emission spectra of indicator fluorophores, e.g., dyes and nanoparticles. To remove fluorophore emission cross-talk in wide-field multispectral fluorescence molecular imaging, we evaluate three different solutions: (1) image stitching, (2) concurrent imaging with cross-talk ratio subtraction algorithm, and (3) frame-sequential imaging. A phantom with fluorophore emission cross-talk is fabricated, and a 1.2-mm ultrathin scanning fiber endoscope (SFE) is used to test and compare these approaches. Results show that fluorophore emission cross-talk could be successfully avoided or significantly reduced. Near term, the concurrent imaging method of wide-field multispectral fluorescence SFE is viable for early stage cancer detection and localization in vivo. Furthermore, a means to enhance exogenous fluorescence target-to-background ratio by the reduction of tissue autofluorescence background is demonstrated.

Color-matched and fluorescence-labeled esophagus phantom and its applications.

We developed a stable, reproducible three-dimensional optical phantom for the evaluation of a wide-field endoscopic molecular imaging system. This phantom mimicked a human esophagus structure with flexibility to demonstrate body movements. At the same time, realistic visual appearance and diffuse spectral reflectance properties of the tissue were simulated by a color matching methodology. A photostable dye-in-polymer technology was applied to represent biomarker probed "hot-spot" locations. Furthermore, fluorescent target quantification of the phantom was demonstrated using a 1.2 mm ultrathin scanning fiber endoscope with concurrent fluorescence-reflectance imaging.

Spectrally enhanced imaging of occlusal surfaces and artificial shallow enamel erosions with a scanning fiber endoscope.

An ultrathin scanning fiber endoscope, originally developed for cancer diagnosis, was used to image dental occlusal surfaces as well as shallow artificially induced enamel erosions from human extracted teeth (n=40). Enhanced image resolution of occlusal surfaces was obtained using a short-wavelength 405-nm illumination laser. In addition, artificial erosions of varying depths were also imaged with 405-, 404-, 532-, and 635-nm illumination lasers. Laser-induced autofluorescence images of the teeth using 405-nm illumination were also obtained. Contrast between sound and eroded enamel was quantitatively computed for each imaging modality. For shallow erosions, the image contrast with respect to sound enamel was greatest for the 405-nm reflected image. It was also determined that the increased contrast was in large part due to volume scattering with a smaller component from surface scattering. Furthermore, images obtained with a shallow penetration depth illumination laser (405 nm) provided the greatest detail of surface enamel topography since the reflected light does not contain contributions from light reflected from greater depths within the enamel tissue. Multilayered Monte Carlo simulations were also performed to confirm the experimental results.

Red-shifted fluorescence of sound dental hard tissue.

Autofluorescence spectra were recorded in vitro from dentin, enamel, and whole teeth. The spectra exhibited a broad peak shifted by about 50 to 75 nm from the excitation wavelength and the shape of the spectra remained similar regardless of the excitation wavelength. The maximum of the autofluorescence spectra also exhibited a red-shift that depended upon the laser excitation wavelength. The amplitude of the red-shifted fluorescence spectra produced by 444 and 532 nm excitation lasers were compared to that produced by a 405 nm excitation laser. It was determined that the autofluorescence amplitude was not proportional to the inverse fourth power of the excitation laser wavelength. Therefore, the red-shifted fluorescence is not compatible with the previously proposed mechanism of Raman scattering. Instead, the mechanism giving rise to the laser-induced dental autofluorescence is explained by the red-edge-excitation effect.