Covered stent assisted coil embolization of large Buhler aneurysm in setting of chronic celiac trunk occlusion.

BACKGROUND: The arc of Bühler (AOB) is a residual embryonal anastomosis between the celiac artery (CA) and the superior mesenteric artery (SMA). Although usually asymptomatic, it has clinical relevance when compensatory reverse flow between the SMA and the CA in response to celiac artery obstruction leads to aneurysm formation and bleeding. Endovascular coiling is the mainstay therapy because of the deep AOB retropancreatic location, which hinders open surgery. CASE PRESENTATION: We herein report a case of a 2.8-cm AOB saccular aneurysm and LAM compression of celiac trunk in a 47-year-old man during rehabilitation following motorcycle trauma and vertebral surgery. The patient was considered unsuitable for surgery. Neither conventional coiling nor bare-metal stent and balloon-assisted techniques for coiling were suitable because of the wide necked saccular shape of AOB aneurysm interposed between the SMA and the floor of celiac trunk. To exclude the aneurysm from direct SMA inflow and permit safe and efficient coiling to rule out retrograde sac perfusion, a 9-mm polytetrafluoroethylene stent graft (Viabahn; Gore, Phoenix, AZ, USA) was positioned in the mesenteric artery, followed by antegrade periprosthetic high-density packed coiling of the aneurysm. The AOB remained excluded from mesenteric perfusion. The patient's clinical condition and abdominal contrast-enhanced multislice computed tomographic findings were unremarkable at the 9-year follow-up. CONCLUSION: The 9 year long-term efficacy in our case raises the possibility that perigraft coiling following stent-graft deployment in the SMA may represent a valuable technical option for large Bühler aneurysms that are not amenable to stand-alone coiling.

Clinical outcomes and periodontal conditions of dental implants placed in free fibula flaps (FFF): a retrospective study with a mean follow-up of 6 years.

OBJECTIVES: Up-to-date literature regarding long-term success of implant rehabilitations after microvascular reconstructions with free fibula flap (FFF) is still very scarce. This study aimed to evaluate clinical outcomes, especially related to oral hygiene conditions, of patients rehabilitated with this technique. MATERIALS AND METHODS: A total of 25 patients who underwent maxillofacial reconstructive surgery with FFF were retrospectively evaluated for soft tissues conditions, oral hygiene habits, and implant survival and success, assessed with a mean follow-up of 6 (range 2-15) years after loading. RESULTS: Fourteen patients received full-arch fixed prostheses and 11 removable bar-supported overdentures. At the follow-up evaluation, 52% of prostheses did not allow proper accessibility for oral hygiene. Overall prosthetic survival was 100%, and implant survival and success were respectively 93.6% and 72%. Prevalence of peri-implantitis was 29% at implant level and that at patient level 96%. CONCLUSIONS: Six-year clinical outcomes of this study reveal that poor oral hygiene practices and compliance by patients who underwent maxillofacial reconstruction with FFF are significantly associated with peri-implant disease. CLINICAL RELEVANCE: Findings of the present study underline the need by clinicians for a careful assessment, in reference to a specific implant therapy, of patient's prosthetic accessibility for oral hygiene procedures.

Sequencing in Orthognathic Bimaxillary Surgery: Which Jaw Should Be Operated First? A Scoping Review.

Bimaxillary orthognathic surgery is widely used for the correction of dentoskeletal deformities. Surgery sequencing (maxilla or mandible first) remains debated, and guidelines and consensus are lacking. This scoping review summarizes the state of the art and compares the advantages and disadvantages of both approaches. The review was conducted following PRISMA-ScR guidelines. Three electronic databases (PubMed, Scopus, Web of Science) were searched using the PICO protocol and key words in orthognathic surgical sequencing. Four reviewers screened the records independently, and disagreement was resolved by consensus. A total of 23 records met the inclusion criteria. The advantages and disadvantages of the two approaches were compared and assessed for accuracy of reporting. Within the limitations of the present study, available evidence for the intrinsic advantages and the accuracy of the mandible-first sequence supports the choice of this approach in most cases. Nevertheless, each clinical case needs to be evaluated individually, as no dogmatic recommendations can be given for sequencing in bimaxillary orthognathic surgery.

Reply to Mattei et al. Jacob Disease, Osteochondroma of the Coronoid Process, Coronoid Process Hyperplasia or Langenbeck Disease: The Big Jumble. Comment on "Raccampo et al. Jacob's Disease: Case Series, Extensive Literature Review and Classification Proposal. J. Clin. Med. 2023, 12, 938".

As authors of the text, we can only thank Mattei et al. [...].

Accuracy of virtual surgical planning in bimaxillary orthognathic surgery with mandible first sequence: A retrospective study.

The aim of this study was to verify treatment accuracy using virtual surgical planning (VSP) with a mandible-first sequence and strict surgical protocol to determine what surgical and methodological factors might influence outcomes. VSP transfer accuracy was evaluated retrospectively through a modified method involving voxel-based superimposition in patients who had undergone bimaxillary surgery with a mandible-first sequence to correct dentoskeletal deformities. Data analysis showed that the movements planned and those executed were substantially equivalent (p < 0.01), with the exception of mandibular and maxillary sagittal movements that were 0.72 ± 0.90 mm and 1.41 ± 1.04 mm smaller, respectively, than planned. This study showed that a mandible-first sequence is accurate for transferring virtual surgical planning intraoperatively. There are several factors involved in the proper transfer of virtual planning beyond the software, such as surgical technique and sequencing. Inaccurate sagittal movements and maxillary repositioning seem to depend mainly on surgical factors.

Jacob's Disease: Case Series, Extensive Literature Review and Classification Proposal.

Jacob's disease is a rare entity consisting of the formation of a pseudojoint between an abnormal coronoid process of the mandible and the inner surface of the zygomatic bone. First described by Jacob in 1899, its diagnosis and definition have never been entirely univocal. In this paper, we present three emblematic cases and an extensive review of the literature on Jacob's disease. Given the variability observed in the presentation of the disease, we have developed a proposal for the classification, here reported.

Stem Cell Fate and Immunomodulation Promote Bone Regeneration via Composite Bio-Oss®/AviteneTM Biomaterial.

Bone defects in maxillofacial regions lead to noticeable deformity and dysfunctions. Therefore, the use of biomaterials/scaffolds for maxillofacial bone regrowth has been attracting great interest from many surgical specialties and experts. Many approaches have been devised in order to create an optimal bone scaffold capable of achieving desirable degrees of bone integration and osteogenesis. Osteogenesis represents a complex physiological process involving multiple cooperating systems. A tight relationship between the immune and skeletal systems has lately been established using the concept of "osteoimmunology," since various molecules, particularly those regulating immunological and inflammatory processes, are shared. Inflammatory mediators are now being implicated in bone remodeling, according to new scientific data. In this study, a profiler PCR array was employed to evaluate the expression of cytokines and chemokines in human adipose derived-mesenchymal stem cells (hASCs) cultured on porous hydroxylapatite (HA)/Collagen derived Bio-Oss®/Avitene scaffolds, up to day 21. In hASCs grown on the Bio-Oss®/Avitene biomaterial, 12 differentially expressed genes (DEGs) were found to be up-regulated, together with 12 DEG down-regulated. Chemokine CCL2, which affects bone metabolism, tested down-regulated. Interestingly, the Bio-Oss®/Avitene induced the down-regulation of pro-inflammatory inter-leukin IL-6. In conclusion, our investigation carried out on the Bio-Oss®/Avitene scaffold indicates that it could be successfully employed in maxillofacial surgery. Indeed, this composite material has the advantage of being customized on the basis of the individual patients favoring a novel personalized medicine approach.

Recommendations for a safe restart of elective aerosol-generating oral surgery procedures following the COVID-19 pandemic outbreak: An Italian multicenter study.

Among healthcare workers, oral and maxillofacial surgeons are some of the most exposed to coronavirus disease (COVID-19). The aim of this retrospective study was to develop suggestions for continuing the work of oral and maxillofacial surgeons using a safe protocol for elective and urgent aerosol-generating procedures that could prevent the onset of new clusters. Based on the results obtained and a guidelines review of those Asian countries that had promptly managed the current pandemic, the following safety protocol was developed.

Mandibular recontouring with polyetheretherketone (PEEK) patient-specific implants.

The definition of the mandibular angle profile is a common challenge for oral and maxillofacial surgeons. Accurate diagnosis and treatment planning are mandatory in order to properly manage soft and hard tissues. The use of several biomaterials is described in the literature. The present paper reports the treatment of a defect in the right mandibular angle in otomandibular syndrome sequelae by positioning polyetheretherketone (PEEK) patient-specific implants (PSI) in a 25-year-old patient who previously underwent orthognathic surgery. Satisfactory aesthetic results were achieved with no complications 12 months after surgery. Considering its advantageous physical properties and the low rate of postoperative complications reported in the literature, PEEK can increase the treatment options for recontouring not only the upper third and the middle third of the face, but also of the lower third, in particular in cases of large three-dimensional defects.

Posterior airways and orthognathic surgery: What really matters for successful long-term results?

INTRODUCTION: Although it is well known that orthognathic surgery modifies the upper airways, it is still unclear which are the determining factors to achieve adequate and predictable results in all the patients regardless of the initial malocclusion type and satisfying all the traditional orthognathic treatment objectives. This study aimed to correlate airway changes with surgical movements and other variables and the planning modalities to better understand how to control airway dimensions with treatment. METHODS: This study involved 61 patients requiring bimaxillary surgery to correct various dentoskeletal deformities without a history of obstructive sleep apnea syndrome. In all the subjects, the orthosurgical treatment was planned according to the same treatment principles and regardless of the initial airway dimension. The 3-dimensional volume and minimal axial area values generated by cone-beam computed tomography at the preoperative, 3-week, and 1-year postoperative controls were evaluated and correlated with surgical movements and other variables. RESULTS: Although the planning did not consider the initial size of the airways, a significant increase was found for volume and minimal axial area in both the short term (volume, 29.0%; area, 51.2%) and long term (volume, 18.2%; area, 39.8%) with no regard to the type of malocclusion. Only 3 of the variables examined were found to significantly affect the airway: the preoperative dimensions, gender, and the extent of mandibular advancement. These 3 explanatory variables combined can predict the 1-year postoperative volume and minimal area with an accuracy of 71% and 44%, respectively. CONCLUSIONS: According to this study, orthosurgical treatment can protect airways from unexpected unfavorable changes and satisfy the other treatment goals regardless of the initial malocclusion as long as the facial deformities are properly addressed for each patient. Furthermore, these results identified 3 main variables that influence postoperative airways dimensions the most. Keeping in mind that the relationship between airway dimensions and obstructive sleep apnea syndrome is not clearly explained, these considerations may prove to be a useful tool to help in preventing and managing this disease. Studies involving larger samples of patients and evaluating more variables are mandatory to better understand the correlation between airways and sleep function.

Combined orthodontic and surgical open bite correction.

OBJECTIVES: To examine the stability of combined surgical and orthodontic bite correction with emphasis on open-bite closure. All study patients were treated with strict and consistent orthodontic and surgical protocols. MATERIALS AND METHODS: Study inclusion required all patients to have anterior open bites, maxillary accentuated curve of Spee, 36-month minimum follow-up, and no temporomandibular joint pathology. Thirty patients met the inclusion/exclusion criteria. Importantly, segmental upper arch orthodontic preparation (performed by EG) was used. Surgery consisted of a multisegment Le Fort I (MSLFI) combined with a bilateral sagittal osteotomies (BSSO). Surgery was performed (by ADA and LT) at the Department of Dentistry and Maxillofacial Surgery of the University of Verona, Italy. RESULTS: The long-term open bite and overjet relapse were not statistically significant. The mean transverse relapse of the upper and lower molars was statistically significant. Of great importance, the upper and lower arch widths narrowed together, maintaining intercuspation of the posterior dentition which prevented anterior open bites from developing. CONCLUSIONS: This study revealed stability of three-dimensional occlusal correction including anterior open bite. Stable open bite closure was achieved by using rigid protocols for orthodontic preparation, surgical techniques, surgical follow-up, and orthodontic finishing.

Transconjunctival and Subciliary Approach in the Treatment of Orbital Fractures: A Study on Oculoplastic Complication.

(1) Background: The aim of the present study was to compare lower eyelid post-operative complications, such as ectropion, entropion, and scleral show of orbital floor fractures, associated to the subciliary vs transconjunctival approaches. (2) Materials and Methods: A retrospective comparative study of patients who underwent surgery for orbital fractures by means of a transconjunctival or a subciliary approach at the Clinic of Dentistry and Maxillofacial Surgery of the University of Verona from January 2013 through September 2018 was designed. Data related to the trauma and to surgical procedures were retrieved, as well as a series of anthropometric parameters extrapolated from standardized photographs. Statistical analysis was performed on the outcomes. (3) Results: 33 patients underwent surgery by means of a transconjunctival approach and 36 patients by means of a subciliary approach. Ectropion was observed to a greater extent in the subciliary group, however the difference resulted to be not statistically significant. Patients in which osteosynthesis devices were used presented with a greater incidence of scleral show with respect to the remaining patients. No statistically significant difference was observed for any of the parameters taken into account. (4) Conclusions: Since the two approaches does not seem to be associated with remarkable differences in terms of outcomes, the choice of technique should be tailored to the patient's features and the surgeon's experience.

Complications related to zygomatic implants placement: A retrospective evaluation with 5 years follow-up.

This retrospective study assessed zygoma implants in patients treated for upper maxilla extreme atrophy, trauma, cleft palate, or failed reconstruction. The implants were placed using Quad (4 zygoma implants) or mixed (zygoma and conventional implants in premaxilla) surgical technique, with intra-sinus or extra-sinus approach, followed by immediate or deferred loading. Clinical and radiographic evaluations were carried out at 5-year follow-up from loading. Implant survival, symptoms and signs of sinusitis, radiological alterations in terms of mucosal thickening or obliteration of the maxillary sinuses, oroantral communications, and peri-implant soft tissues were examined. A total of 42 patients, with 116 zygoma implants, were included in the study. The cumulative survival rate was 97.41%. One zygomatic bone fracture was assessed. Eight patients reported sinusitis, and two showed oro-antral communications. A comparison between mean pre- and post-operative Lund-Mackay scores showed a statistically significant increase of sino-nasal disease in the post-operative scores (p = 0.0019). Mucositis and gingival recession was observed in 21 and 8 implants respectively. Average recession was 2.52 ± 2.35 mm. According to our results, placement of zygoma implants has proved to be a predictable procedure, with a lower rate of severe complications compared to other treatment options in extreme upper jaw atrophy.

Have There Been any Changes in the Epidemiology and Etiology of Maxillofacial Trauma During the COVID-19 Pandemic? An Italian Multicenter Study.

ABSTRACT: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has had a significant impact on people's behavior. The aim of this study has been to evaluate how the SARS-CoV-2 pandemic has impacted the incidence and the features of maxillofacial fractures presented at 6 Italian tertiary centers. Clinical records of all the patients diagnosed for facial fractures between February 23 and May 23, 2019 and 2020 were retrospectively reviewed. Any differences in patient number and characteristics and fracture etiology and site between the 2 groups were then statistically analyzed.There has been a 69.1% decrease in the number of incoming patients during the pandemic. The number of foreign patients has decreased significantly (23.3% versus 9.6%, P = 0.011) while the average age has increased (38.6 versus 45.6 years old, P = 0.01). Specific statistical significant differences for accidental falls (31.8% versus 50.1%, P = 0.005) and sports injuries (16.9% versus 1.4%, P < 0.001) were found. Concerning fracture sites, significant differences have been found in relation to nasal (22.5% versus 11.4%, P = 0.009) and frontal sinus (0.9% versus 4.4%, P = 0.037) fractures. In conclusion, SARS-CoV-2 pandemic has significantly changed the epidemiology and the etiology of facial traumas.

The effect of subspinal Le Fort I osteotomy and alar cinch suture on nasal widening.

The aim of this retrospective study was to evaluate the relationships between upper jaw movements and nasal soft-tissue changes in patients who have undergone subspinal Le Fort I osteotomy combined with alar cinch suture. Single and multivariate linear regression analyses were used to examine the relationships between greatest inter-alar width (GAW) and maxillary advancement, maxillary impaction, and rotational movements. The database of our referral hospital was searched for patients who had undergone upper jaw surgery with a subspinal LFI osteotomy to correct dentoskeletal deformities between April 2012 and June 2016. Thirty-eight of the patients (15 men and 23 women) who were identified were eligible for inclusion. The average change in inter-alar width (ΔGAW) was +1.7 ± 1.2 mm. GAW increased by 0.3 mm (p < 0.0001) for each millimetre of maxillary advancement, and increased by 0.5 mm (p < 0.0001) for each millimetre of maxillary impaction. GAW increased by 0.2 mm for each degree of counterclockwise rotation of the occlusal plane (p < 0.0001). An analysis of our data compared with the current literature confirmed that subspinal Le Fort I combined with alar cinch suture reduced alar base widening.

Enhanced Osteogenic Differentiation of Human Bone Marrow-Derived Mesenchymal Stem Cells by a Hybrid Hydroxylapatite/Collagen Scaffold.

Human bone marrow-derived mesenchymal stem cells (hBMSCs) and their derivative enhanced green fluorescent protein (eGFP)-hBMSCs were employed to evaluate an innovative hybrid scaffold composed of granular hydroxylapatite and collagen hemostat (Coll/HA). The cellular morphology/cytoskeleton organization and cell viability were investigated by immunohistochemistry (IHC) and AlamarBlue metabolic assay, respectively. The expression of osteopontin and osteocalcin proteins was analyzed by IHC and ELISA, whereas osteogenic genes were investigated by quantitative PCR (Q-PCR). Cell morphology of eGFP-hBMSCs was indistinguishable from that of parental hBMSCs. The cytoskeleton architecture of hBMSCs grown on the scaffold appeared to be well organized, whereas its integrity remained uninfluenced by the scaffold during the time course. Metabolic activity measured in hBMSCs grown on a biomaterial was increased during the experiments, up to day 21 (p < 0.05). The biomaterial induced the matrix mineralization in hBMSCs. The scaffold favored the expression of osteogenic proteins, such as osteocalcin and osteopontin. In hBMSC cultures, the scaffold induced up-regulation in specific genes that are involved in ossification process (BMP2/3, SPP1, SMAD3, and SP7), whereas they showed an up-regulation of MMP9 and MMP10, which play a central role during the skeletal development. hBMSCs were induced to chondrogenic differentiation through up-regulation of COL2A1 gene. Our experiments suggest that the innovative scaffold tested herein provides a good microenvironment for hBMSC adhesion, viability, and osteoinduction. hBMSCs are an excellent in vitro cellular model to assay scaffolds, which can be employed for bone repair and bone tissue engineering.

Hydroxylapatite-collagen hybrid scaffold induces human adipose-derived mesenchymal stem cells to osteogenic differentiation in vitro and bone regrowth in patients.

Tissue engineering-based bone graft is an emerging viable treatment modality to repair and regenerate tissues damaged as a result of diseases or injuries. The structure and composition of scaffolds should modulate the classical osteogenic pathways in human stem cells. The osteoinductivity properties of the hydroxylapatite-collagen hybrid scaffold named Coll/Pro Osteon 200 were investigated in an in vitro model of human adipose mesenchymal stem cells (hASCs), whereas the clinical evaluation was carried out in maxillofacial patients. Differentially expressed genes (DEGs) induced by the scaffold were analyzed using the Osteogenesis RT2 PCR Array. The osteoinductivity potential of the scaffold was also investigated by studying the alkaline phosphatase (ALP) activity, matrix mineralization, osteocalcin (OCN), and CLEC3B expression protein. Fifty patients who underwent zygomatic augmentation and bimaxillary osteotomy were evaluated clinically, radiologically, and histologically during a 3-year follow-up. Among DEGs, osteogenesis-related genes, including BMP1/2, ALP, BGLAP, SP7, RUNX2, SPP1, and EGFR, which play important roles in osteogenesis, were found to be upregulated. The genes to cartilage condensation SOX9, BMPR1B, and osteoclast cells TNFSF11 were detected upregulated at every time point of the investigation. This scaffold has a high osteoinductivity revealed by the matrix mineralization, ALP activity, OCN, and CLEC3B expression proteins. Clinical evaluation evidences that the biomaterial promotes bone regrowth. Histological results of biopsy specimens from patients showed prominent ossification. Experimental data using the Coll/Pro Osteon 200 indicate that clinical evaluation of bone regrowth in patients, after scaffold implantation, was supported by DEGs implicated in skeletal development as shown in "in vitro" experiments with hASCs.

Does Middle Meatal Antrostomy Prevent the Onset of Maxillary Sinusitis After Zygomatic Implant Placement?

PURPOSE: To evaluate the role of middle meatal antrostomy in preventing the onset of maxillary sinusitis after placement of zygomatic implants. We hypothesized that middle meatal antrostomy might reduce the incidence of this complication. MATERIALS AND METHODS: A prospective longitudinal study was performed of patients who had undergone placement of 4 zygomatic implants and concurrent middle meatal antrostomy with an endoscopic approach at the maxillofacial surgery unit of Verona University. The radiological results of the maxillary sinuses were evaluated on computed tomography scans performed 12 months after surgery using the Lund-Mackay staging system. Clinical symptoms were evaluated both preoperatively and 12 months after surgery using the Sino-Nasal Outcome Test-20 (SNOT-20). Intraoperative violation of the Schneiderian membrane was also assessed. The outcomes from the present study were compared with historical controls. RESULTS: The sample included 13 patients, 26 maxillary sinuses with negative radiologic findings of sinonasal pathologic features, and 52 zygomatic implants. A moderate increase was found in radiologic findings of sinonasal pathologic features postoperatively compared with preoperatively, with mucosal hypertrophy in 3 maxillary sinuses (11.5%). The incidence and severity of mucosal hypertrophy was significantly lower than the outcomes of the historical controls. The average preoperative SNOT-20 score was 13.45, and the postoperative SNOT-20 score was 1.18. The Schneiderian membrane was pierced in 13 sinuses in 9 patients. CONCLUSIONS: Shrinkage of the ostiomeatal complex seems to play a fundamental role in the onset of sinonasal pathologic features after zygomatic implant placement compared with implant-related causes. Although functional endoscopic sinus surgery is a supplementary surgical method in implant placement, it seems to provide statistically significant improvement in the health of the sinonasal system. Perforation of the Schneiderian membrane does not appear to correlate with the onset of sinus opacification and sinonasal symptoms.

Is post orthognathic maxillary sinusitis related to sino-nasal anatomical alterations?

Le Fort I osteotomies have been used for more than five decades, but their impact on nasal and paranasal cavities physiology, has not been studied deeply. In this paper we want to analyse the possible correlation between post-orthognathic findings and prevalence of sinusitis which require surgical treatment. A retrospective cohort study was designed in 2017; the study was designed and carried out in the Verona University maxillo-facial department, a referral centre for orthognathic surgery. The study population is made of 64 patients that underwent orthognathic surgery (To treat class II or III malocclusion) between 2010 and 2015. Inclusion criteria were the availability of a Cone Beam Computed Tomography (CBCT) before surgery and one between 12 and 24 months after orthognathic surgery. Exclusion criteria were smoking habit and previous orthognathic procedures. During follow-up time prevalence of sinusitis was 18.5% and some patients required a secondary surgery to treat sinusitis. Surgery induced anatomic alterations were frequent in patients with sinusitis, sings and symptoms of sinusitis show positive correlation with anatomic alterations.

Does Piezosurgery Influence the Severity of Neurosensory Disturbance Following Bilateral Sagittal Split Osteotomy?

The present paper aims to evaluate the long-term incidence and severity of the neurosensory disturbance (NSD) of the inferior alveolar nerve following bilateral sagittal split osteotomy (BSSO) of the mandibular ramus performed with piezosurgery. A retrospective study on patients referred to the Maxillofacial Surgery and Dentistry Clinic of the University of Verona for orthognathic surgery between March 2013 and October 2015 was performed. Inclusion criteria were having undergone BSSO with piezosurgery and follow-up lasting at least 24 months. Exclusion criteria were history of surgical infection, osteosynthesis failure or re-do surgery. The extent of mandibular repositioning movements was retrieved and patients underwent 4 clinical neurosensory tests. Descriptive statistical analysis was performed. 52 patients met the inclusion criteria. Average follow-up was 40 months (range 24-75). 83% of the nerves examined have no or slightly altered sensitivity. Seventy-one percent of patients perceive a moderate to none discomfort and none describes the discomfort as serious (Visual Analogue Scale [VAS] >7). The extent of mandibular repositioning did not have significant influence on the development and severity of the NSD. Resulting data led the Authors to infer that using piezosurgery in BSSO, the severity of the NSD of inferior alveolar nerve is reduced, but the incidence of permanent nerve lesions remains unchanged, compared to historical controls.