The inter-laboratory validation study of EpiSensA for predicting skin sensitization potential.

The Epidermal Sensitization Assay (EpiSensA) is a reconstructed human epidermis (RhE)-based gene expression assay for predicting the skin sensitization potential of chemicals. Since the RhE model is covered by a stratified stratum corneum, various kinds of test chemicals, including lipophilic ones and pre-/pro-haptens, can be tested with a route of exposure akin to an in vivo assay and human exposure. This article presents the results of a formally managed validation study of the EpiSensA that was carried out by three participating laboratories. The purpose of this validation study was to assess transferability of the EpiSensA to new laboratories along with its within- (WLR) and between-laboratory reproducibility (BLR). The validation study was organized into two independent stages. As demonstrated during the first stage, where three sensitizers and one non-sensitizer were correctly predicted by all participating laboratories, the EpiSensA was successfully transferred to all three participating laboratories. For Phase I of the second stage, each participating laboratory performed three experiments with an identical set of 15 coded test chemicals resulting in WLR of 93.3%, 93.3%, and 86.7%, respectively. Furthermore, when the results from the 15 test chemicals were combined with those of the additional 12 chemicals tested in Phase II of the second stage, the BLR for 27 test chemicals was 88.9%. Moreover, the predictive capacity among the three laboratories showed 92.6% sensitivity, 63.0% specificity, 82.7% accuracy, and 77.8% balanced accuracy based on murine local lymph node assay (LLNA) results. Overall, this validation study concluded that EpiSensA is easily transferable and sufficiently robust for assessing the skin sensitization potential of chemicals.

Midpalatal miniscrews and high-pull headgear for anteroposterior and vertical anchorage control: cephalometric comparisons of treatment changes.

INTRODUCTION: Our aim was to evaluate which anchorage system is better suited for both anteroposterior and vertical anchorage control of maxillary posterior teeth. METHODS: Fifty-one subjects requiring maximum anchorage were divided into 2 groups according to maxillary posterior anchorage reinforcement: high-pull headgear, conventional transpalatal arch, and interarch elastics (n = 28); or modified transpalatal arch supported by 2 midpalatal miniscrews (n = 23). Bilateral maxillary first premolars were extracted in all patients. Pretreatment and posttreatment lateral cephalometric radiographs were superimposed to compare skeletal and dental changes between the groups. RESULTS: (1) The miniscrew group had less mesial movement of the maxillary first molars (0.85 vs 3.63 mm) and greater maxillary incisor retraction (6.87 vs 4.50 mm) than did the headgear group with the same treatment duration. (2) The maxillary molars were significantly intruded in the miniscrew group (1.30 mm), whereas they were extruded in the headgear group (0.71 mm). In the miniscrew group, intrusion of the maxillary molars resulted in a statistically significant decrease in the mandibular plane angle (0.80°). Patients using high-pull headgear showed no significant decrease in these measurements. CONCLUSIONS: In both the anteroposterior and vertical directions, a modified transpalatal arch supported by 2 midpalatal miniscrews provided more stable anchorage.

Effective approach for improving a gummy smile : Upward movement of the maxillary occlusal plane using midpalatal miniscrews and a modified transpalatal arch.

PURPOSE: Correction of a gummy smile by orthodontic treatment alone has recently become feasible with the use of miniscrews. However, the optimal treatment mechanics remain unclear. Here we cephalometrically evaluated jaw and tooth displacement in cases where a gummy smile was improved using a level anchorage system (LAS). METHODS: Sixteen patients underwent orthodontic treatment using an LAS consisting of a modified transpalatal arch and midpalatal miniscrews. Cephalometric pretreatment and posttreatment measurements were compared using the paired t­test to determine significant skeletal and dental changes. The Mann-Whitney U test was used for nonparametric data. Spearman's rank correlation coefficient was used to evaluate correlations between different variables and the vertical change in prosthion position which was used to indicate the amount of gingival exposure. RESULTS: The changes noted after treatment were intrusion of the maxillary first molars (P < 0.001) combined with only minor extrusion of the mandibular first molars. Suppressed extrusion of the mandibular first molars was significantly correlated with greater upward movement of the prosthion (r = 0.676, P < 0.01). Upward movement of the prosthion was also significantly correlated with intrusion of the maxillary and mandibular incisors, anterior upward movement of the maxillary occlusal plane, and an increase of the SNP angle. CONCLUSIONS: Treatment involving the combined use of miniscrews and a modified transpalatal arch resulted in intrusion of the maxillary first molars and maxillary incisors and consequently elevated the maxillary occlusal plane. The results of this study suggest that intruding the maxillary occlusal plane and minimizing mandibular molar extrusion were effective to induce autorotation of the mandible and to improve a gummy smile.

Optimal sites for orthodontic anchor screw placement using panoramic images: risk of maxillary sinus perforation and contact with adjacent tooth roots during screw placement.

OBJECTIVES: This study investigated the safety of orthodontic anchor screw (OAS) placement by examining the morphology and degree of depression of the maxillary sinus adjacent to the alveolar bone between the maxillary molars. METHODS: We reviewed panoramic and CT imaging data of 25 patients. First, the morphology of the maxillary sinus adjacent to the alveolar bone between the maxillary molars on panoramic images was classified into three types: non-depressed sinus, funnel-like sinus depression, and sawtooth-like sinus depression. Then, the distance from the maxillary buccal bone to the maxillary sinus or to the maxillary lingual bone and the distance between the roots of the maxillary second premolar and first molar at heights of 5, 6.5, and 8 mm from the alveolar crest were measured on CT images and compared between the three sinus morphology groups. RESULTS: The sawtooth-like depression group had significantly smaller bone thickness than the other two groups, with mean thickness of < 4 mm at any height from the alveolar crest. The funnel-like depression and non-depression groups had mean bone thickness of > 8 mm at any height from the alveolar crest. CONCLUSIONS: Sawtooth-like sinus depression had increased risk of maxillary sinus perforation, suggesting that OAS placement in this region should be avoided. In contrast, OAS placement between 6.5 and 8 mm from the alveolar crest is advisable in patients with funnel-like sinus depression and at a site > 8 mm from the alveolar crest in those with a non-depressed sinus.

Reproducibility of maxillofacial landmark identification on three-dimensional cone-beam computed tomography images of patients with mandibular prognathism: Comparative study of a tentative method and traditional cephalometric analysis.

OBJECTIVE: To clarify the reproducibility of a tentative method for identifying maxillofacial landmarks on three-dimensional (3D) images obtained with cone-beam computed tomography (CBCT) for dental use in patients with mandibular prognathism. Also, the influence of level of experience of dentists applying the method was investigated by dividing them into two groups according to experience. MATERIALS AND METHODS: Dentists with less (group A) or more (group B) than 3 years of experience of cephalometry and 3D image manipulation analyzed CBCT data from 10 patients using two different landmark identification methods: method 1 used conventional cephalometric definitions and method 2 used detailed landmark identification definitions developed for each cross-sectional plane. The plotting of nine landmarks was performed twice, and 10 coordinate values were obtained for each landmark. To assess reproducibility, the 95% confidence ellipse method was used. RESULTS: Comparative analysis showed that method 2 was highly reproducible. Group B subjects attained smaller ellipsoid volumes than group A subjects, regardless of the landmark identification method used. With method 1, except for condyle and coronoid process, all landmarks showed a higher level of reproducibility in group A subjects than in group B subjects. With method 2, however, five landmarks showed no differences between the methods. CONCLUSION: The method proposed here may be highly reproducible regardless of the evaluators' experience.

Reproducibility of three-dimensional coordinate systems based on craniofacial landmarks: a tentative evaluation of four systems created on images obtained by cone-beam computed tomography with a large field of view.

OBJECTIVES: To propose a method for evaluating the reproducibility of anatomical coordinate systems based on craniofacial skeletal landmarks and to tentatively evaluate four systems created on preoperative cone-beam computed tomography (CBCT) data obtained from mandibular prognathism patients in order to confirm the utility for actual patients' data. MATERIALS AND METHODS: In three-dimensional images of 10 patients obtained by a CBCT with a large field of view, six dentists set four coordinate systems that were created in different ways, twice by plotting some landmarks situated in the superior portion of the maxillofacial skeletons. The 95% confidence ellipse of six objective landmarks related to the jaw and teeth (upper incisor, left upper first molar, lower incisor, left lower first molar, menton, and left gonion) were three-dimensionally drawn for each coordinate system. The ellipsoid volume was calculated to evaluate the reproducibility of the coordinate systems. RESULTS: The reproducibility could be evaluated for each coordinate system using the method proposed. The coordinate systems that were created by landmarks situated at greater distances from each other showed relatively small ellipsoid volume in comparison to those with shorter distances between landmarks. CONCLUSION: Anatomical coordinate systems with larger distances between the landmarks used were stable when landmarks related to the jaw and teeth were assigned as objective landmarks. The method proposed here was effective in terms of the reproducibility evaluation of a coordinate system.

Reproducibility of landmark identification in the jaw and teeth on 3-dimensional cone-beam computed tomography images.

OBJECTIVE: To compare the reproducibility of landmark identification on three-dimensional (3D) cone-beam computed tomography (CBCT) images between procedures based on traditional cephalometric definitions (procedure 1) and those tentatively proposed for 3D images (procedure 2). MATERIALS AND METHODS: A phantom with embedded dried human skull was scanned using CBCT. The acquired volume data were transferred to a personal computer, and 3D images were reconstructed. Eighteen dentists plotted nine landmarks related to the jaws and teeth four times: menton (Me), pogonion (Po), upper-1 (U1), lower-1 (L1), left upper-6 (U6), left lower-6 (L6), gonion (Go), condyle (Cd), and coronoid process (Cp). The plotting reliabilities of the two procedures were compared by calculating standard deviations (SDs) in three components (x, y, and z) of coordinates and volumes of 95% confidence ellipsoid. RESULTS: All 27 SDs for procedure 2 were less than 1 mm, and only five of them exceeded 0.5 mm. The variations were significantly different between the two procedures, and the SDs of procedure 2 were smaller than those of procedure 1 in 21 components of coordinates. The ellipsoid volumes were also smaller for procedure 2 than procedure 1, although a significant difference was not found. CONCLUSIONS: Definitions determined strictly on each three sectional images, such as for procedure 2, were required for sufficient reliability in identifying the landmark related to the jaws and teeth.