Periapical Microsurgery: Assessment of Different Types of Light-emitting Diode Transilluminators in Detection of Dentinal Defects

This study evaluated 4 different light-emitting diode (LED) transilluminators and the impact of operator experience in the detection of dentinal defects through an ex vivo TRUEJAW surgical model (Dental Engineering Laboratories, Santa Barbara, CA).Forty-four extracted and endodontically treated mandibular premolar teeth were evaluated. Teeth were mounted in the models followed by surgical flaps and osteotomies to expose the apical third of the roots. After apical resection, the root-end surfaces were randomly inspected for the presence or absence of dentinal defects using a dental operating microscope (DOM) at ×19.4 magnification by experienced and novice LED evaluators. The assessment was made with the DOM light and 4 masked LED transilluminators of different diameters and luminous flux. The teeth were examined outside the models to establish the ground truth. The sensitivity, specificity, and kappa and McNemar test values of each light source by examiner were calculated.
The use of LED transilluminators improved the diagnostic sensitivity of dentinal defects when compared with the DOM light alone for both examiners. For the LED-experienced evaluator, the medium-low transilluminator had statistically significant higher sensitivity than the DOM light and the small-low and small-high transilluminators (P < .05). For the novice LED evaluator, the medium-high transilluminator had the highest sensitivity. There was a statistically significant difference between the sensitivities of the medium-low transilluminator between the examiners (P < .05).Within the limitations of this ex vivo surgical study, dentinal defects were more often detected with the LED transilluminators with a larger diameter and increased lumens. The operator’s LED transilluminator experience was found to have a positive effect on the detection of dentinal defects using transillumination.

Optical characterization of cutaneous transilluminators for eye safety

Cutaneous transilluminators are light-emitting devices used to localize blood vessels for various medical procedures. They are often used in populations that may be at increased risk for skin burns, such as neonates and the elderly. While there is a known potential for skin burns, little is known about the ophthalmic risk from the use of these devices.
This paper will report on the laboratory evaluation of the potential ocular hazards from transilluminators (TIs). Our results indicate that transilluminators which incorporate white-light LEDs have emissions that have the potential for producing injury to the retina, especially in patients who may have a reduced aversion response.

Effective date of requirement for premarket approval for transilluminator for breast evaluation and sorbent hemoperfusion system (SHS) devices for the treatment of hepatic coma and metabolic disturbances; reclassification of SHS and devices for the treatment of poisoning and drug overdose. Final order.

The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) for the transilluminator for breast evaluation and sorbent hemoperfusion system (SHS) devices for the treatment of hepatic coma and metabolic disturbances and to reclassify SHS devices for the treatment of poisoning and drug overdose, a preamendments class III device, into class II (special controls).

New ways to deal with known preanalytical issues: use of transilluminator instead of tourniquet for easing vein access and eliminating stasis on clinical biochemistry

Tourniquet due venous stasis can alter both concentration and/or activity of several blood analytes, but is rarely regarded as an issue of laboratory variability. To overcome the problem transillumination devices (TD) have been proposed for a stasis-free phlebotomy. In this paper the use of a TD in place of tourniquet during blood collection has been evaluated.
Blood was collected from 250 volunteers divided in five homogenous groups of tourniquet times (G1: 30 sec, G2: 60 sec, G3: 90 sec, G4:120 sec, G5: 180 sec) and compared to blood obtained using TD. All samples were analyzed for glucose (GLU), total protein (TP), albumin (ALB), triglycerides (TRIG), potassium (K), sodium (NA), phosphate (PHOS), calcium (CA), alkaline phosphatase (ALKP) and magnesium (MG).
In respect of TD, G1 did not show statistically significant increases in all clinical chemistry tests; G2 showed increases for GLU, TP, ALB, TRIG, K, CA, MG and ALKP. G3 and G4, showed no significant increase only for PHOS. G5 showed significant increases in all the tests evaluated. Moreover, clinically significant variations were observed for TP, ALB, K and CA in G2 to G5; for NA in G3 to G5; for MG in G4 and G5; for GLU, TRIG, ALKP only in G5.
These results support the application of TD in blood collection for routine clinical chemistry laboratory tests, suggesting its use should be more diffused.

Optical-thermal characterization of cutaneous transilluminators

In recent years, there has been an increase in the popularity of light-emitting diode (LED)-based, battery-powered transilluminators (BPTs) for facilitating transdermal vascular access in adults and neonates. BPTs are believed to have lower potential for inducing skin burns than prior devices based on high-power broadband lamps; however, the optical and thermal outputs of BPTs are not well documented and safety limits for these devices are not well established. In this study, we characterize and assess the optical and thermal outputs of six BPTs that incorporate red, orange and white LEDs. Optical measurements included spectral irradiance and peak local irradiance.
Thermal measurements included transient temperature readings for an exposure time of 4 min in ambient air and ex vivo tissue pre-heated to physiological temperatures. The greatest mean temperature rise produced in tissue by a non-white-light diode BPT was 2.5 degrees C, whereas a mean temperature rise of 9.1 degrees C was measured in a BPT that incorporated white-light diodes with relatively high irradiance levels. The dominant cause of temperature rise was most likely heat generation within the devices. Thermal damage analyses based on temperature limits and the Arrhenius equation indicate that although some of the devices studied approach the threshold for damage, none appear to exceed it under normal operating conditions. The results demonstrated that ambient air measurements may be suitable for identifying worst-case BPT temperatures. This study highlights the potential risk of LED-based medical devices as well as the need for additional research on related issues such as neonatal thermal injury thresholds.


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