Effects of virtual reality on psychophysical measures of pain: superiority to imagination and nonimmersive conditions.

ABSTRACT: Virtual reality (VR) has been shown to be effective in pain management. However, to date, little is known about the mechanisms by which immersive experiences influence pain processing. The aim of this study was to investigate the direct effects of an immersive VR environment on the perception of experimental pain in individuals with chronic pain and pain-free controls. The immersion in a VR landscape was compared with mental imagery and a nonimmersive control condition. Using a randomized within-crossover design, pressure pain detection and tolerance thresholds, spatial and temporal summation (SSP, TSP), and conditioned pain modulation (CPM) were measured in 28 individuals with chronic pain and 31 pain-free controls using phasic cuff pressure on the legs. Direct comparison between the groups showed that although individuals with pain had significantly lower pain thresholds, reduced CPM effects, and increased TSP, the VR condition had the same pain-inhibitory effect on pain thresholds as in pain-free controls. Conditioned pain modulation effects were reduced by all conditions compared with baseline. There were no significant differences between conditions and baseline for TSP and SSP. Overall, pain modulatory effects were largest for VR and smallest for imagery. These results demonstrate that immersion in a VR environment has an increasing effect on pain thresholds, reduces pain inhibition in a CPM paradigm, and has no effects on TSP. This applies for participants with chronic pain and pain-free controls. These VR effects exceeded the effects of mental imagery on the nonimmersive control condition. This indicates that VR effectively modulates pain perception in both patients and controls irrespective of differences in pain perception.

Effect of firing time and wall thickness on the biaxial flexural strength of 3D-printed zirconia.

OBJECTIVES: To evaluate the effect of accelerated firing on 3D-printed zirconia. METHODS: To check if formulae provided by ISO 6872 can be extended to thin samples, finite element analyses were carried out in advance of fabricating 3-mol% yttria-stabilized tetragonal zirconia polycrystal discs by milling and by 3D-printing. Four groups (n = 38 each) of 3D-printed specimens were produced with two nominal thicknesses (0.6 mm and 1.2 mm) and two firing strategies (long: 51 h, accelerated: 14.5 h). In the milled group (thickness 1.2 mm, n = 30), a standard firing program (9.8 h) was selected. Biaxial flexural strength tests were applied and mean strength, characteristic strength, and Weibull modulus were calculated for each group. Differences were analyzed using Welch ANOVA and Dunnett-T3 post-hoc tests. RESULTS: Maximum tensile stresses occurring during biaxial strength testing can be calculated according to ISO 6872 for thin samples with b > 0.3 mm. Variability of measured strengths values was smaller for milled zirconia compared with 3D-printed zirconia. The 1.2-mm-thick 3D-printed samples had significantly decreased strength after accelerated firing than after long firing. However, for the 0.6-mm-thick samples, comparable mean biaxial strength values of about 1000 MPa were measured for both firing protocols. SIGNIFICANCE: At the moment, long fabrication time for zirconia restorations is a major drawback of 3D-printing when compared with milling technology. This investigation showed that the strength of 0.6-mm-thick zirconia discs fabricated by 3D-printing was not impaired by accelerated firing. Thus, overnight firing of thin-walled 3D-printed zirconia restorations could be possible.

Oral Sequelae after Head and Neck Radiotherapy: RCT Comparing 3D-Printed Tissue Retraction Devices with Conventional Dental Splints.

OBJECTIVES: To evaluate oral sequelae after head and neck radiotherapy (RT) when using two different types of intraoral appliances. Thermoplastic dental splints (active control) protect against backscattered radiation from dental structures. Semi-individualized, 3D-printed tissue retraction devices (TRDs, study group) additionally spare healthy tissue from irradiation. MATERIALS AND METHODS: A total of 29 patients with head and neck cancer were enrolled in a randomized controlled pilot trial and allocated to receive TRDs (n = 15) or conventional splints (n = 14). Saliva quality and quantity (Saliva-Check, GC), taste perception (Taste strips, Burghart-Messtechnik), and oral disability (JFLS-8, OHIP-14, maximum mouth opening) were recorded before and 3 months after RT start. Radiotherapy target volume, modality, total dose, fractionation, and imaging guidance were case-dependent. To evaluate intra-group developments between baseline and follow-up, nonparametric Wilcoxon tests were performed. Mann-Whitney-U tests were applied for inter-group comparisons. RESULTS: At follow-up, taste perception was unimpaired (median difference in the total score; TRDs: 0, control: 0). No significant changes were found regarding oral disability. Saliva quantity (stimulated flow) was significantly reduced with conventional splints (median -4 mL, p = 0.016), while it decreased insignificantly with TRDs (median -2 mL, p = 0.07). Follow-up was attended by 9/15 study group participants (control 13/14). Inter-group comparisons showed no significant differences but a tendency towards a better outcome for disability and saliva quality in the intervention group. CONCLUSION: Due to the small cohort size and the heterogeneity of the sample, the results must be interpreted with reservation. Further research must confirm the positive trends of TRD application. Negative side-effects of TRD application seem improbable.

Thermo-flexible resin for the 3D printing of occlusal splints: A randomized pilot trial.

OBJECTIVES: To compare the clinical performance of occlusal splints printed from thermo-flexible resin with milled splints. METHODS: A parallel two-arm pilot trial was initiated. Forty-seven patients (n women=38) were recruited from a tertiary care center and randomized using an online tool (sealed envelope). Inclusion criterion was an indication for treatment with a centric relation occlusal splint due to bruxism or any form of painful temporomandibular disorder. Patients were excluded if they were younger than 18 years, unable to attend follow-up appointments, or required another type of splint therapy. Patients received either, a 3D-printed (intervention group, V-print splint comfort, VOCO) or a milled splint (control group, ProArt CAD splint, Ivoclar). Construction software Ceramill M-splint (AmannGirrbach), 3D-printer MAX UV 385 (Asiga) and milling unit PrograMill PM7 (Ivoclar) were used. Follow-up assessments were conducted after 2 weeks and 3 months. Outcome measures were survival, adherence, technical complications, patient satisfaction on a 10-point Likert scale, and maximum wear using superimposition of optical scans. RESULTS: After 3 months, 20/23 intervention group and 18/24 control group participants were assessed. All splints survived. Minor complications were small crack formations on 6 printed and 4 milled splints. Mean patient satisfaction was 8 (SD 1.7) for printed, and 8.1 (SD 2.3) for milled splints (r = 0.1, p = .52). Median maximum wear was highly dispersed with 153 (IQR 140) in posterior and 195 (IQR 537) in frontal segments of printed, and 96 (IQR 78) respectively, 123 (IQR 155) of milled splints, (both: r = 0.31, p = .084). CONCLUSIONS: Within the limitations of a pilot trial, 3D-printed and milled splints performed similarly in terms of patient satisfaction, complication rates and wear behavior. CLINICAL SIGNIFICANCE: Thermo-flexible material was proposed for 3D printing of occlusal splints to overcome mechanical weaknesses of previously available resins. This randomized pilot study provides evidence that this material is a viable alternative to milled splints for at least three months of clinical use. Further evidence on long-term use should be obtained.

Dual-energy CT-based stopping power prediction for dental materials in particle therapy.

Radiotherapy with protons or light ions can offer accurate and precise treatment delivery. Accurate knowledge of the stopping power ratio (SPR) distribution of the tissues in the patient is crucial for improving dose prediction in patients during planning. However, materials of uncertain stoichiometric composition such as dental implant and restoration materials can substantially impair particle therapy treatment planning due to related SPR prediction uncertainties. This study investigated the impact of using dual-energy computed tomography (DECT) imaging for characterizing and compensating for commonly used dental implant and restoration materials during particle therapy treatment planning. Radiological material parameters of ten common dental materials were determined using two different DECT techniques: sequential acquisition CT (SACT) and dual-layer spectral CT (DLCT). DECT-based direct SPR predictions of dental materials via spectral image data were compared to conventional single-energy CT (SECT)-based SPR predictions obtained via indirect CT-number-to-SPR conversion. DECT techniques were found overall to reduce uncertainty in SPR predictions in dental implant and restoration materials compared to SECT, although DECT methods showed limitations for materials containing elements of a high atomic number. To assess the influence on treatment planning, an anthropomorphic head phantom with a removable tooth containing lithium disilicate as a dental material was used. The results indicated that both DECT techniques predicted similar ranges for beams unobstructed by dental material in the head phantom. When ion beams passed through the lithium disilicate restoration, DLCT-based SPR predictions using a projection-based method showed better agreement with measured reference SPR values (range deviation: 0.2 mm) compared to SECT-based predictions. DECT-based SPR prediction may improve the management of certain non-tissue dental implant and restoration materials and subsequently increase dose prediction accuracy.

Head and Neck Pain Drawing Area Correlates With Higher Psychosocial Burden But Not With Joint Dysfunction in Temporomandibular Disorders: A Cross-Sectional Study.

Head and neck pain drawings have been introduced as part of the diagnostic gold standard for temporomandibular disorders (TMD). We aimed to quantify the spatial extent of pain in TMD patients and to analyze its association with further clinical findings. In a cross-sectional study, 90 patients (median age = 38 years; n women = 68) were diagnosed according to the DC/TMD. Intra-articular disorders were either confirmed or rejected by magnetic resonance imaging. The patients shaded all painful areas in a sketch of the left and right side of a face. A grid template was placed over the drawings and each region that contained markings was scored as painful. The correlation between the calculated area and the psychosocial variables (DC/TMD axis II) as well as the influence of pain lateralization were investigated using Spearman correlation, Mann-Whitney-U and chi-square tests. Pain affected all facial areas but concentrated on the regions of the temporomandibular joint and masseter origin. Thirty-nine percent reported purely unilateral pain, which was associated with structural TMJ findings in 77% of cases. Individuals with bilateral pain and those with greater spatial spread of pain had significantly higher scores on all axis II variables, except for functional limitation of the jaw. PERSPECTIVE: Head and neck pain drawings can contribute to a stratification of TMD patients. A greater extent of pain as well as pain bilateralization is associated with higher levels of emotional distress, pain chronicity and somatization, but not with functional impairment. Unilateral reporting of pain is associated with more intra-articular disorders.

Fit of anterior restorations made of 3D-printed and milled zirconia: An in-vitro study.

OBJECTIVES: To evaluate the fit of zirconia veneers made by either 3D printing or milling. METHODS: A typodont maxillary central incisor was prepared for a 0.5-mm-thick veneer and was reproduced 36 times from resin. Restorations were designed with a 20-µm-wide marginal and a 60-µm-wide internal cement gap, and were made from 3D-printed zirconia (LithaCon 3Y 210, Lithoz, n = 24) and milled zirconia (Cercon ht, DentsplySirona, n = 12). For milled zirconia, a drill compensation was needed to give the milling bur access to the intaglio surface. The restorations were cemented, cross-sectioned, and the cement gap size was analyzed by two raters. Inter-rater reliability was studied at 12 3D-printed veneers (intraclass correlation coefficient, ICC, mixed model, absolute agreement). Twelve remaining 3D-printed restorations were compared with 12 milled restorations regarding fit at three locations: marginally, labially, and at the incisal edge (Mann-Whitney U-tests, α<0.05). RESULTS: Inter-rater reliability was excellent, with an ICC single-measure coefficient of 0.944 (95%-confidence interval: [0.907; 0.966]). Gap sizes (mean ± SD / maximum) were 55 ± 9 / 143 µm at the margins, 68 ± 14 / 130 µm labially, and 78 ± 19 / 176 µm at the incisor edge for 3D-printed veneers. For milled veneers, gap sizes were 44 ± 11 / 141 µm at the margins, 85 ± 19 / 171 µm labially, and 391 ± 26 / 477 µm at the incisor edge. At the margins, the milled veneers outperformed the 3D-printed restorations (p = 0.011). The cement gap at the incisor edge was significantly smaller after 3D printing (p < 0.001). CONCLUSIONS: 3D-printed zirconia restorations showed clinically acceptable mean marginal gaps below 100 µm. Because drill compensation could be omitted with 3D printing, the fit at the sharp incisal edge was significantly tighter than with milling. CLINICAL SIGNIFICANCE: The fit of 3D-printed ceramic anterior restorations meets clinical standards. In addition, 3D printing is associated with a greater geometrical freedom than milling. With regard to fit this feature allows tighter adaptation even after minimally invasive preparation.

Nonsurgical treatment of class III malocclusion with temporomandibular disorder comorbidity: A clinical report.

The treatment of a 57-year-old woman with combined skeletal and pseudo-class III malocclusion who was also suffering from chronic myofascial orofacial pain is described. The challenge was to treat the patient's malocclusion while simultaneously managing the temporomandibular disorder. After a successful 3-month occlusal device therapy, which substantially reduced the patient's discomfort, a nonsurgical therapy by using complete-mouth fixed restorations was planned. The treatment was first tested by using printed interim restorations before monolithic zirconia restorations were provided. Stable occlusion and a pain-free outcome were observed at the 3-month follow-up.

Effect of grinding on the optical properties of monolithic zirconia.

OBJECTIVES: The purpose of this study was to analyze the color infiltration in monolithic zirconia after grinding, which plays an essential role in the color stability of restorations after occlusal adjustment. METHODS: One hundred and eight white zirconia plates (36 Dentsply Sirona-Cercon high translucency [C], 36 Zirkonzahn-Prettau [P], 36 Zirkonzahn-Prettau anterior [Pa]) were stained by infiltration with target colors Vita A2, A3.5, and A4. In a standardized experimental setup, all plates were grinded in nine successive steps (from baseline to 500 µm), and color was measured with a spectroradiometer at each grinding step. Color differences ΔE00 between initial color and after each grinding step were calculated. The data was analyzed using regression, Kruskal-Wallis test, inverse prediction, and simultaneous 95%-confidence intervals. RESULTS: Grinding had a significant effect on color stability across all zirconia types and target colors (p < 0.001). At each cut level and target color, ΔE00 means for groups C, P, and Pa were statistically different (p < 0.05). Among the three zirconia types, Pa had the lowest ΔE00 mean score for cut levels 20-100 µm for A2 and between 50 and 300 µm for A3.5 and A4. For all other cut levels, differences between Pa and P were not significant (α = 0.05). C had the largest mean ΔE00 except for A4 until 100 µm, where it was second best. CONCLUSION: Zirconia type had a significant effect on the color infiltration depth across all target colors. Pa showed the best color stability until 150 µm material reduction, whereas C presented significantly less color stability than the other two zirconia materials. CLINICAL SIGNIFICANCE: Color stability is important for minimizing the risk of restoration failure due to unacceptable color changes after grinding. Pa is less susceptible to color change and has an additional buffer of 60 µm until exceeding the color acceptability threshold. When higher flexural strength is needed, P is to be preferred.

Effect of grinding adjustments on the color of monolithic zirconia.

STATEMENT OF PROBLEM: Monolithic zirconia restorations have become popular because of their excellent mechanical properties and acceptable esthetics. While the biomechanical properties of zirconia have been investigated, research into their esthetic properties is sparse. Zirconia can be colored by infiltration before sintering, although how occlusal adjustment can affect restoration color is unclear. PURPOSE: The purpose of this in vitro study was to analyze the color of differently characterized monolithic white and precolored zirconia specimens after standardized grinding. MATERIAL AND METHODS: White and precolored monolithic zirconia plates (Cercon ht) (n=36) were stained by infiltration with target colors Vita A2, A3.5, and A4. In a standardized experimental arrangement, all plates were ground in 9 steps, and the color was measured with a spectroradiometer at each step. Color differences (ΔE00) were analyzed by using regression analysis, the Kruskal-Wallis test, and the inverse prediction with confidence intervals (α=.05). RESULTS: Mechanical material removal had a significant effect on the color stability (P<.05) of both white and precolored monolithic zirconia. For each grinding step and each target color, the precolored groups had a significantly lower ΔE00 mean than the white groups (P<.05), except at the 20-µm step for groups W-A4 and P-A4 (P>.05). For target color A2, the difference was significant with P<.001 at all 9 grinding steps. For target color A3.5, the difference was significant with P=.003 at grinding level 20 µm, and P<.001 for all other grinding steps. For target color A4, the difference was not significant with P=.603 at grinding level 20 µm, whereas the difference was significant with P=.007 at grinding level 50 µm, and with P<.001 for all other grinding steps. CONCLUSIONS: Precolored zirconia had less color change after grinding than white zirconia. This study established grinding depths for white and precolored zirconia corresponding to color perceptibility and acceptability thresholds.

Geometric Reproducibility of Three-Dimensional Oral Implant Planning Based on Magnetic Resonance Imaging and Cone-Beam Computed Tomography.

This study aimed to investigate the geometric reproducibility of three-dimensional (3D) implant planning based on magnetic resonance imaging (MRI) and cone-beam computed tomography (CBCT). Four raters used a backward-planning approach based on CBCT imaging and standard software to position 41 implants in 27 patients. Implant planning was repeated, and the first and second plans were analyzed for geometric differences regarding implant tip, entry-level, and axis. The procedure was then repeated for MRI data of the same patients. Thus, 656 implant plans were available for analysis of intra-rater reproducibility. For both imaging modalities, the second-round 3D implant plans were re-evaluated regarding inter-rater reproducibility. Differences between the modalities were analyzed using paired t-tests. Intra- and inter-rater reproducibility were higher for CBCT than for MRI. Regarding intra-rater deviations, mean values for MRI were 1.7 ± 1.1 mm/1.5 ± 1.1 mm/5.5 ± 4.2° at implant tip/entry-level/axis. For CBCT, corresponding values were 1.3 ± 0.8 mm/1 ± 0.6 mm/4.5 ± 3.1°. Inter-rater comparisons revealed mean values of 2.2 ± 1.3 mm/1.7 ± 1 mm/7.5 ± 4.9° for MRI, and 1.7 ± 1 mm/1.2 ± 0.7 mm/6 ± 3.7° for CBCT. CBCT-based implant planning was more reproducible than MRI. Nevertheless, more research is needed to increase planning reproducibility-for both modalities-thereby standardizing 3D implant planning.

Removable partial dentures retained by hybrid CAD/CAM cobalt-chrome double crowns: 1-year results from a prospective clinical study: CAD/CAM cobalt-chrome double crowns: 1-year results.

OBJECTIVES: Computer-aided design and manufacturing (CAD/CAM) has been successfully used to replace conventional steps in the fabrication of double crowns, creating hybrid-workflows that might facilitate the wider application of these restorations in the future. However, in-vivo data are still lacking. METHODS: A prospective clinical trial was designed in which 20 patients (median age = 69 years; n women = 10) with 73 abutment teeth who needed a double-crown-retained removable partial denture (RPD) were consecutively recruited. While most of the work steps were done conventionally, gypsum models were digitized with a laboratory scanner to allow CAD/CAM fabrication of primary crowns and secondary structures. DentalDesigner software (3Shape) was used in combination with milling unit PrograMillPM7 and Co-Cr- blanks (Ivoclar-vivadent). Connectors were milled from wax, transferred to Co-Cr using lost-wax technique and bonded to the secondary crowns. Clinical follow-ups were scheduled 6 and 12 months after prosthesis insertion. Outcome parameters were complication-free survival of RPDs and abutment teeth after one year. RESULTS: After 12 months, complication-free survival was 74% and 91% for the RPDs and abutment teeth, respectively. Complications comprised decementations (n = 5), abutment tooth fractures (n = 2), fracture of denture teeth (n = 1), and loss of abutment teeth (n = 1). These complications were easily manageable, resulting in 1-year survival of 100% for CAD/CAM RPDs. CONCLUSIONS: First data on short-term complication rates of CAD/CAM double-crown-retained RPDs appear promising. To gather further evidence, prospective clinical trials over a longer follow-up time and with larger patient groups are required. CLINICAL SIGNIFICANCE: Hybrid CAD/CAM double-crown retained RPDs showed a successful clinical application after one year of follow-up. Further research is needed to evaluate their performance in comparison to conventional manufacturing methods.

Non-invasive three-dimensional thickness analysis of oral epithelium based on optical coherence tomography-development and diagnostic performance.

OBJECTIVES: Evaluating structural changes in oral epithelium can assist with the diagnosis of cancerous lesions. Two-dimensional (2D) non-invasive optical coherence tomography (OCT) is an established technique for this purpose. The objective of this study was to develop and test the diagnostic accuracy of a three-dimensional (3D) evaluation method. METHODS: The oral lip mucosa of 10 healthy volunteers was scanned using an 870-nm spectral-domain OCT device (SD-OCT) with enhanced depth imaging (EDI). Four raters semi-automatically segmented the epithelial layer twice. Thus, eighty 3D datasets were created and analyzed for epithelial thickness. To provide a reference standard for comparison, the raters took cross-sectional 2D measurements at representative sites. The correlation between the 2D and 3D measurements, as well as intra- and inter-rater reliability, were analyzed using intraclass correlation coefficients (ICC). RESULTS: Mean epithelial thickness was 280 ± 64µm (range 178-500 µm) and 268 ± 49µm (range 163-425 µm) for the 2D and 3D analysis, respectively. The inter-modality correlation of the thickness values was good (ICC: 0.76 [0.626-0.846]), indicating that 3D analysis of epithelial thickness provides valid results. Intra-rater and inter-rater reliability were good (3D analysis) and excellent (2D analysis), suggesting high reproducibility. CONCLUSIONS: Diagnostic accuracy was high for the developed 3D analysis of oral epithelia using non-invasive, radiation-free OCT imaging. CLINICAL SIGNIFICANCE: This new 3D technique could potentially be used to improve time-efficiency and quality in the diagnosis of epithelial lesions compared with the 2D reference standard.

Accuracy of 3D printing compared with milling - A multi-center analysis of try-in dentures.

OBJECTIVES: In recent years, computer-aided design/computer-aided manufacturing (CAD/CAM) has been used to produce removable complete dentures. Most workflows include fabrication of milled or 3D-printed try-in prostheses. 3D-printing accuracy is affected by laboratory-specific and operator-dependent factors. This international five-center study sought to compare the accuracy of 3D-printed and milled try-in dentures. METHODS: The construction file of a maxillary removable complete denture was selected as a reference. Eight try-in dentures were 3D printed at each of the five centers. Each center used their own printer (Objet260 Connex, Stratasys; MAX, Asiga; Anycubic Photon, Anycubic 3D; PRO2, Asiga and cara Print 4.0, Kulzer) along with their own material, printing settings, post-processing and light-curing parameters. At center 2, eight try-in dentures were milled to serve as a benchmark (PrograMill PM7, Ivoclar Vivadent). Dentures were scanned and aligned to the reference file using best-fit algorithms. Geometric accuracy was analyzed using the root mean square value (trueness) and standard deviation (precision) of the distributed absolute mesh deviations. Mean values of the five sets of printed dentures and the single set of milled dentures were compared. RESULTS: Milled dentures showed a mean trueness of 65 ±â€¯6 µm and a mean precision of 48 ±â€¯5 µm. Thus, they were significantly more accurate than the 3D-printed dentures in four out of five centers. In mean absolute numbers, 3D printing was less true than milling by 17-89 µm and less precise by 8-66 µm. CONCLUSIONS: Although milling remains the benchmark technique for accuracy, differences between milled and 3D-printed dentures were non-significant for one printing center. Furthermore, the overall performance of 3D printing at all centers was within a clinically acceptable range for try-in prostheses. CLINICAL SIGNIFICANCE: The accuracy of 3D printing varies widely between and within laboratories but nonetheless lies within the range of accuracy of conventional manufacturing methods.

Tissue Retraction for Head and Neck Radiotherapy in Edentulous Patients.

Tissue retraction devices (TRDs) are used for head and neck radiotherapy to displace soft tissues and fixate the mandible. They can increase the accuracy of irradiation and reduce its side effects, such as oral mucositis. However, no method has been described for fabrication of TRDs in edentulous patients. In this case report, an edentulous 67-year-old patient undergoing radiotherapy of the tongue was provided with a TRD. The tongue was immobilized, ensuring irradiation consistency and the retraction of healthy oral tissues. Using 3D printing, an efficient workflow for fabrication of TRDs based on the patient's existing complete prostheses can be realized.

Individualized 3D-Printed Tissue Retraction Devices for Head and Neck Radiotherapy.

BACKGROUND: Radiotherapy for head and neck cancer may cause various oral sequelae, such as radiation-induced mucositis. To protect healthy tissue from irradiation, intraoral devices can be used. Current tissue retraction devices (TRDs) have to be either individually manufactured at considerable cost and time expenditure or they are limited in their variability. In this context, a 3D-printed, tooth-borne TRD might further facilitate clinical use. METHODS: A novel approach for the manufacturing of TRDs is described and its clinical application is analysed retrospectively. The devices were virtually designed for fabrication by 3D-printing technology, enabling-in only a single printing design-caudal or bi-lateral tongue displacement, as well as stabilization of a tongue-out position. For a total of 10 patients undergoing radiotherapy of head and neck tumors, the devices were individually adapted after pre-fabrication. Technical and clinical feasibility was assessed along with patient adherence. Tissue spacing was calculated by volumetric analysis of tongue retraction. In one exemplary case, radiotherapy treatment plans before and after tissue displacement were generated and compared. The reproducibility of maxillomandibular relation at device re-positioning was quantified by repeated intraoral optical scanning in a voluntary participant. RESULTS: 3D-printing was useful for the simplification of TRD manufacture, resulting in a total patient treatment time of less than 30 min. The devices were tolerated well by all tested patients over the entire radiation treatment period. No technical complications occurred with the devices. The TRDs caused an effective spacing of the healthy adjacent tissue, e.g., the tongue. Position changes of maxillomandibular relation were limited to a mean value of 98.1 µm ± 29.4 µm root mean square deviation between initial reference and follow-up positions. CONCLUSIONS: The presented method allows a resource-efficient fabrication of individualized, tooth-bourne TRDs. A high reproducibility of maxillomandibular relation was found and the first clinical experiences underline the high potential of such devices for radiotherapy in the head and neck area.

3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial.

BACKGROUND: Despite modern treatment techniques, radiotherapy (RT) in patients with head and neck cancer (HNC) may be associated with high rates of acute and late treatment-related toxicity. The most effective approach to reduce sequelae after RT is to avoid as best as possible healthy tissues and organs at risk from the radiation target volume. Even small geometric changes can lead to a significant dose reduction in normal tissue and better treatment tolerability. The major objective of the current study is to investigate 3D printed, tooth-borne tissue retraction devices (TRDs) compared to conventional dental splints for head and neck RT. METHODS: In the current two-arm randomized controlled phase II trial, a maximum of 34 patients with HNC will be enrolled. Patients will receive either TRDs or conventional dental splints (randomization ratio 1:1) for the RT. The definition of the target volume, modality, total dose, fractionation, and imaging guidance is not study-specific. The primary endpoint of the study is the rate of acute radiation-induced oral mucositis after RT. The quality of life, local control and overall survival 12 months after RT are the secondary endpoints. Also, patient-reported outcomes and dental status, as well as RT plan comparisons and robustness analyzes, will be assessed as exploratory endpoints. Finally, mesenchymal stem cells, derived from the patients' gingiva, will be tested in vitro for regenerative and radioprotective properties. DISCUSSION: The preliminary clinical application of TRD showed a high potential for reducing acute and late toxicity of RT in patients with HNC. The current randomized study is the first to prospectively investigate the clinical tolerability and efficacy of TRDs for radiation treatment of head and neck tumors. TRIAL REGISTRATION: ClinicalTrials.gov; NCT04454697; July 1st 2020; https://clinicaltrials.gov/ct2/show/record/NCT04454697 .

Color stability of individually stained monolithic zirconia following occlusal adjustment.

OBJECTIVE: To meet esthetic requirements, monolithic zirconia can be stained by color-infiltration. However, adjustments of occlusal surfaces are often necessary, leading to demasking effects if too much of the color-infiltrated layer is removed. The effect of subsequent material removal on color stability of individually stained zirconia is analyzed here. MATERIALS AND METHODS: Thirty-six white zirconia disks were divided into three groups. Standardized staining strategies for tooth colors VITA A2, A3.5, and A4 were developed and applied to the disks. Samples were grinded in nine successive steps from 20 to 500 µm. A spectroradiometer was used to measure the color differences after each step. Regression analyses were performed for color differences from baseline as a function of depth of material removal. Depth of material removal resulting in color changes surpassing the acceptability threshold of ΔE00 = 1.8 was estimated using inverse prediction. RESULTS: Up to 500 µm material removal, color difference ΔE00 changes linearly with the depth of material removal (P < 0.05). Regression analyses showed coefficients of determination (R2 ) of 0.97 (VITA A2), 0.87 (VITA A3.5), and 0.96 (VITA A4). Acceptability threshold was surpassed at 62, 87, and 92 µm, respectively. CONCLUSIONS: Discolorations occur within clinically relevant occlusal adjustments of <100 µm. The effect is more severe with lighter, less saturated tooth colors. CLINICAL SIGNIFICANCE: Staining that is resistant to occlusal adjustments and abrasion is only possible if the staining solution infiltrates sufficiently deep into the ceramic structure. This study provides for the first time in the literature numerical values that describe the thresholds of acceptability of color differences in zirconia ceramics. These values are essential because they determine the extent of possible occlusal adjustments, and thus the color stability. Further research is necessary to improve the infiltration depth of staining solutions.