A Randomised Controlled Trial of Postoperative Sensitivity after Class II Restoration with Bulk-Fill vs Conventional Composites.

INTRODUCTION: Bulk-fill composites may simplify posterior restorations, saving time and reducing technical complexity. Post-operative sensitivity is a risk of posterior composites; bulk-fill composites could mitigate this. This single centre, double-blinded, parallel groups randomised controlled trial compared postoperative sensitivity following restoration of class II carious lesions with bulk-fill or conventional, layered composite. NULL HYPOTHESIS: there will be no difference in post-operative sensitivity between the two materials. METHODS: Participants requiring class II restoration of posterior teeth were randomised to bulk-fill (FU) (Coltene Fill-UpTM) or conventional, layered (BE) (Coltene Brilliant Everglow) composite. Allocation was concealed during cavity preparation. Only the operating dentist knew allocation. The outcome was 24 h post-operative sensitivity. RESULTS: 41 patients were randomised (20/group). Two patients from FU group were excluded from analysis (factors unrelated to intervention). There was no difference in postoperative sensitivity at 24 h nor any time point. Only participant age and baseline sensitivity scores significantly impacted post-operative sensitivity. One restoration debonded in FU group at 10 days, with no other adverse effects. No difference in time taken to place restorations was seen. CONCLUSIONS: Within the study's limitations, post-operative sensitivity after class II posterior restorations was no different in bulk-fill restorations compared with conventional, incrementally cured composite.

Malignant salivary gland tumours: treatment outcomes from a tertiary referral centre in the UK.

Salivary gland malignant tumours are a complex and highly variable pathological group. Their diagnosis can be challenging, and management is guided by multidisciplinary teams. This project aimed to establish clinicopathological and sociodemographic features that significantly impacted overall disease-free or progression-free survival in patients diagnosed with malignant salivary gland disease between 2010 and 2019 in a tertiary referral centre. In total, 86 patients were included for analysis, with a female:male gender ratio of 1.3:1. Mean age at diagnosis was 57.7 years. Mucoepidermoid carcinomas constituted almost 25% (n = 20) of all cases, with adenoid cystic carcinomas (20%, n = 17) and acinic cell carcinomas (17.5%, n = 15) being the next most frequently diagnosed. The parotid gland was the most frequently affected site (80.2%, n = 69). Perineural and lymphovascular invasion, and a maximum tumour dimension of ≥4 cm were highly associated with the decision to provide a neck dissection as part of treatment. Involved margins, extracapsular spread, and lymphovascular and perineural invasion were associated with the need for adjuvant treatment. However, no factors remained statistically significant on multivariate analysis. This retrospective service evaluation demonstrates the difficulty of predicting treatment outcomes for patients diagnosed with malignant salivary gland disease.

Follow-up arrangements in head and neck cancer clinics during the COVID-19 pandemic: results from two tertiary UK head and neck cancer centres.

INTRODUCTION: The aim of this paper is to report the pattern of follow-up that occurred for a cohort of head and neck cancer (HNC) patients across two large centres in the UK (Aintree and Leeds), as a consequence of the COVID-19 pandemic. METHODS: Patients had been treated for HNC with curative intent between April 2017 and October 2019 by 14 oral and maxillofacial (OMFS) and ear nose and throat (ENT) oncology surgeons in the Patient Concerns Inventory intervention trial. In October 2020, hospital records were reviewed, and information collected on the timing and mode (face-to-face/telephone/video) of follow-up consultations. In addition, recurrence, second primary tumours and deaths were recorded. RESULTS: At the start of 'lockdown', 212 members of the cohort were known to be alive. During the post-lockdown period (follow-up appointment data comprised 5 months in Aintree and 7 months in Leeds) 7 died and 13 were identified as palliative/recurrence/new primary/metastases ('new event'). In Aintree, the first ENT/OMFS consultations after lockdown were 51 (67%) telephone and 25 (33%) face-to-face appointments. In Leeds, 46 (78%) consultations were by telephone and 13 (22%) were face-to-face. The second ENT/OMFS consultations post lockdown included 11 (44%) telephone and 14 (56%) face-to-face in Aintree, and 21 (75%) telephone and 7 (25%) face-to-face in Leeds. CONCLUSIONS: These data suggest that clinicians favoured remote consultations. Variations in practice were observed but reached a point of a 'hybrid follow-up approach' that included both face-to-face and remote consultations. With the emergence of telemedicine, clinicians may consider a follow-up model tailored to risk stratification. The development of the mode of such a consultation model needs further evaluation.

Outcomes of anastomotic venous flow couplers in head and neck free flap reconstruction - five-year experience in a single centre.

Flow couplers for venous anastomosis, which enable the invasive monitoring of free flaps during the postoperative period with a continuous venous signal audible immediately after completion of the anastomosis, have been reported to be reliable, sensitive, and specific as anastomotic flap monitoring adjuncts. The purpose of this study was to evaluate the reliability, sensitivity, specificity, and outcomes of surgical exploration, and the impact on free-flap survival of the venous anastomotic flow coupler for microvascular head and neck reconstruction in a consecutive series of patients. This is a retrospective review of consecutive patients treated in the department of oral and maxillofacial surgery who underwent reconstruction of a head and neck defect using venous anastomosis with a flow coupler-vascularised free flap between October 2015 and December 2020. A total of 189 patients had free-flap reconstruction of head and neck defects. We compared the venous flow coupler group (n = 72) with patients who had free flaps with hand-sewn anastomoses over the same period (n = 117). There were no false positive/negatives associated with the flow coupler as an implantable flap monitor. The flow coupler cohort had a significantly higher flap salvage rate compared with free flaps that were monitored clinically (p = 0.04). The venous flow coupler has been shown to be a reliable microvascular anastomotic and invasive flap monitor that enables accurate and timely detection of flap compromise and prompt, successful free-flap salvage.

Risk stratification for poor health-related quality of life following head and neck cancer through the aid of a one-page item prompt list.

The aim of this work was to evaluate the usability of a single-page, patient-completed, condition-specific prompt list, the Patient Concerns Inventory (PCI-HN), to risk-stratify for poor health-related quality of life (HRQOL). Data were collected between 2008 and 2017. The main dataset comprised 310 patients first completing the PCI-HN and University of Washington Quality of Life questionnaire (UW-QOLv4) between 2012 and 2017. Another 201 patients first completing the PCI-HN between 2008 and 2011 provided a second dataset for independent validation. Subsequent completions of the PCI-HN in both groups and the distress thermometer (DT) were also used as further validation datasets. Associations between PCI-HN items selected by patients and a range of UW-QOLv4 outcomes were explored using conventional logistic regression and Chi-squared automated interaction detection (CHAID) analyses. One quarter of patients reported less than good HRQOL, range 26-29% across the four datasets. Several individual items from within the PCI-HN were predictive of adverse outcomes. The total number of items selected was also predictive. The single-sheet prompt list enables clinicians to identify patients at high risk of poor HRQOL. This simple approach has the potential to be integrated into routine clinical practice.

Current practice in the management of peripheral ameloblastoma: a structured review.

Ameloblastoma is the most common benign, but locally destructive, epithelial odontogenic tumour. Peripheral ameloblastoma may involve soft tissues without invasion or involvement of bone. The aim of this structured review was to evaluate the literature and guide clinical management. Three online databases were searched for relevant studies: Medline, EMBASE, and Ovid Evidence-Based Medicine, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. A total of 520 papers were initially identified, and after exclusions were applied, 45 were included. Conservative surgical excision was the treatment of choice. There was no consensus in relation to the extent of the surgical margins required. The management of peripheral ameloblastoma appears to favour conservative excision with narrow margins of normal tissue. Follow up of at least 10 years is recommended to monitor for recurrence.

Development of a protocol for assessment of suicide risk in patients with head and neck cancer.

Head and neck cancer (HNC) is the 7th most prevalent cancer globally, with an increasing incidence in recent years which is expected to continue. For many patients, the experience of receiving a diagnosis of HNC and subsequent treatment is disturbing and traumatic. Evidence suggests that HNC patients have a significantly increased risk of suicide compared with other cancer patients and the general population. Multiple social and medical factors may increase suicide risk in an individual, and include smoking and alcohol misuse. Given the elevated rate of suicide among HNC patients it is prudent to routinely assess patients for suicidal ideation to prevent unnecessary deaths by suicide. However, to the authors' knowledge, such assessments are not undertaken in most centres. This article describes the development of a suicide risk assessment protocol proposed for use in HNC patients in a major University Teaching Hospital in Leeds. The basic structure of this protocol could easily be adopted to other centres.

Best practice in reducing the suicide risk in head and neck cancer patients: a structured review.

The treatment of head and neck cancer (HNC) is often radical and the patient's journey challenging, especially for individuals who are struggling with pre-existing mental health problems and who lack social support. Patients frequently suffer from high levels of emotional distress at some point before, during, or after treatment, and their risk of suicide is markedly elevated. This structured review aimed to identify the extent of the problem, appropriate interventions, and areas for future research. We found that the incidence of suicide among HNC patients was significantly elevated above that of the demographically matched general population. Furthermore, the risk was frequently higher in patients with HNC than in those with cancers in other sites. Despite the clear burden of suicide in patients with HNC, there is an absence of evidence on interventions used to reduce suicidal ideation and the risk of suicide. Recommendations for practice are made, drawing from the wider literature on the prevention of suicide.

Total laparoscopic radical hysterectomy: a change in practice for the management of early stage cervical cancer in a U.K. cancer center.

In order to evaluate the safety, surgical, and oncological outcomes of the introduction of a total laparoscopic radical hysterectomy (TLRH) service, the authors conducted a retrospective review of all TLRHs performed in the present centre from the beginning of the service in August 2010. TLRH appears in this series to be safe. Complication rates were comparable to National Institute for Health and Clinical Excellence (NICE) and literature standards. Oncological outcomes, despite the short follow up period, appear acceptable. TLRH is a valuable alternative to open surgery for the treatment of early cervical cancer.

High-speed tensile test instrument.

A novel high-speed tensile test instrument is described, capable of measuring the mechanical response of elastomers at strain rates ranging from 10 to 1600 s(-1) for strains through failure. The device employs a drop weight that engages levers to stretch a sample on a horizontal track. To improve dynamic equilibrium, a common problem in high speed testing, equal and opposite loading was applied to each end of the sample. Demonstrative results are reported for two elastomers at strain rates to 588 s(-1) with maximum strains of 4.3. At the higher strain rates, there is a substantial inertial contribution to the measured force, an effect unaccounted for in prior works using the drop weight technique. The strain rates were essentially constant over most of the strain range and fill a three-decade gap in the data from existing methods.

NGO initiatives in risk reduction: an overview.

NGOs appear to be well placed to play a significant role in natural disaster mitigation and preparedness (DMP), working, as they do, with poorer and marginalised groups in society. However, there is little information on the scale or nature of NGO DMP activities. This paper reports the findings of a study seeking to address that gap. It confirms that NGOs are involved in a diverse range of DMP activities but that a number of them are not labelled as such. Moreover, evidence of the demonstrable quality and benefits of DMP involvement is poor. The paper concludes that a number of problems need to be overcome before DMP can be satisfactorily mainstreamed into NGO development and post-disaster rehabilitation programmes. However, there are some early indications of momentum for change.

Spontaneous tubal re-canalisation: a late complication of Falope ring sterilisation.

The case presented demonstrates the possibility of late failure of laparoscopic female sterilisation due to migration of a Falope ring with tubal recanalisation as a possible mechanism.

DNA integrity in human spermatozoa: relationships with semen quality.

The literature contains conflicting evidence regarding the existence of DNA damage in spermatozoa from infertile male patients. To examine this phenomenon, we have studied ejaculated spermatozoa from normozoospermic semen donors and from a group of the unselected male partners of couples attending an infertility clinic for initial investigation. Classical semen analysis according to World Health Organization (WHO) guidelines was undertaken with computer-assisted sperm analysis (CASA). Spermatozoa were prepared by sequential washing and centrifugation and were analyzed for DNA fragmentation using three assays: 1) a single-cell gel electrophoresis (comet) assay, 2) in situ nick translation with prior chemical decondensation (ISNT-decondensed), and 3) in situ nick translation without prior chemical decondensation (ISNT-condensed). In addition, reactive oxygen species (ROS) generation by spermatozoa was measured, and seminal plasma was analyzed for its total reactive antioxidant potential (TRAP). When the donor and patient groups were compared, the latter had lower levels of semen quality and higher levels of DNA damage, which was particularly apparent using the comet assay. Highly significant negative correlations were observed between DNA fragmentation, detected by all three assays, and semen quality, particularly sperm concentration. In addition, multiple regression analysis indicated that other attributes of semen quality, such as sperm movement and ROS generation, were also related to DNA damage. We conclude that a significant proportion of infertile men have elevated levels of DNA damage in their ejaculated spermatozoa.

Obligatory medical insurance in Russia: the participants' perspective.

The Russian Federation adopted a nation-wide system of obligatory medical insurance in 1993 in an effort to earmark a targeted source of funding for health care and to reverse a steep decline in health outcomes. The author conducted a survey in 1995-1996 of managers of two of the new institutional participants in Russia's health insurance scheme: Territorial Health Insurance Funds and private medical insurance companies. The survey results reveal deep dissatisfaction with the level of financing provided by the new system; continuing confusion and substantial regional variation in the implementation of the insurance legislation; fierce bureaucratic and institutional infighting between the major players, stemming primarily from controversy over delineation of responsibilities and ongoing battles for control over resources; promising hints of competition and other market-based incentives emerging from the current chaos; and broad agreement that further structural reform must accompany increased infusions of resources in order for significant systemic improvements to be realized.

Regional variation in Russian medical insurance: lessons from Moscow and Nizhny Novgorod.

The implementation of Russia's 1993 legislation on obligatory medical insurance has been characterized by wide regional variation. Two areas in particular illustrate this phenomenon: for the last five years Moscow has enjoyed a sophisticated, well-developed insurance system, while the Nizhny Novgorod region has only recently taken the most rudimentary steps toward implementation of the law. Despite their radically differing approaches to the market-based insurance reforms, however, Moscow and Nizhny Novgorod continue to enjoy roughly the same quality of available health care services, at similar costs to consumers. They also suffer some of the same continued systemic defects inherited from the Soviet era. A comparison of the two regions demonstrates that, while reform of the Soviet health care system was desperately needed, the Russian version of obligatory medical insurance has not proved to be the panacea its architects intended. In fact, even its original pioneers are now moving forward with new schemes to correct some of its deficiencies.

Relative impact of oxidative stress on the functional competence and genomic integrity of human spermatozoa.

Reactive oxygen metabolites are known to disrupt sperm-oocyte fusion, sperm movement, and DNA integrity; however, the relative sensitivities of these elements to oxidative stress are unknown. In this study these factors were assessed in human spermatozoa exposed to increasing levels of oxidative stress achieved through the stimulation of endogenous oxidant generation with NADPH or direct exposure to hydrogen peroxide. At low levels of oxidative stress, DNA fragmentation was significantly reduced while the rates of sperm-oocyte fusion were significantly enhanced. As the level of oxidative stress increased, the spermatozoa exhibited significantly elevated levels of DNA damage (p < 0.001) and yet continued to express an enhanced capacity for sperm-oocyte fusion. At the highest levels of oxidative stress, extremely high rates of DNA fragmentation were observed but the spermatozoa exhibited a parallel loss in their capacities for movement and oocyte fusion. These studies emphasize how redox mechanisms can either enhance or disrupt the functional and genomic integrity of human spermatozoa depending on the intensity of the oxidative stimulus. Because these qualities are affected at different rates, spermatozoa exhibiting significant DNA damage are still capable of fertilizing the oocyte. These results may have long-term implications for the safety of assisted conception procedures in cases associated with oxidative stress.

Oxidative damage to DNA in human spermatozoa does not preclude pronucleus formation at intracytoplasmic sperm injection.

We present the first evidence that genetically damaged human spermatozoa are able to form normal pronuclei in oocytes after intracytoplasmic sperm injection (ICSI). The role of reactive oxygen species (ROS) as a cause of chromatin and DNA damage is well recognized. The same class of molecule can be found in the semen of males with severe infertility, who remained infertile until the advent of ICSI. In this study we have investigated the role of ROS in the induction of chromatin damage, DNA strand breakage and the subsequent ability of spermatozoa to decondense and form pronuclei after ICSI. Spermatozoa from normozoospermic men participating in our research programme were exposed to oxidizing environments created by co-incubation with hydrogen peroxide, reduced nicotinamide adenine dinucleotide phosphate (NADPH) or activated white cells. The subsequent ability of the spermatozoa to decondense in vitro was examined using sequential incubations in EDTA, dithiothreitol and sodium dodecyl sulphate, and the amounts of DNA strand breakage were assessed using an in-situ nick translation protocol. Finally, cells exposed to hydrogen peroxide, NADPH and activated leukocytes were microinjected into hamster oocytes, and their ability to decondense and form normal pronuclei was determined. The results indicate that human sperm chromatin becomes cross-linked under conditions of oxidative stress and exhibits increased DNA strand breakage, yet the rate of pronucleus formation is no different from that of untreated control cells. The ability of genetically damaged spermatozoa to achieve normal fertilization following ICSI has implications for the practice of this form of assisted conception therapy.

Analysis of the impact of intracellular reactive oxygen species generation on the structural and functional integrity of human spermatozoa: lipid peroxidation, DNA fragmentation and effectiveness of antioxidants.

Exposure of human spermatozoa to nicotinamide adenine dinucleotide phosphate (NADPH) resulted in the dose dependent generation of reactive oxygen species (ROS) which, at a critical level of intensity, induced lipid peroxidation, DNA damage and a dramatic decline of sperm motility. This system was then used as a model for screening the ability of different antioxidants to combat oxidative stress created through the excessive intracellular generation of toxic oxygen products of metabolism. A variety of antioxidants that has previously been shown to be protective against extracellularly derived oxidants (e.g. superoxide dismutase, catalase, vitamin E, hypotaurine) were ineffective in this system. Albumin, however, could provide complete protection against NADPH induced oxidative stress via mechanisms that did not involve the suppression of the lipid peroxidation cascade but rather the inactivation of lipid peroxides generated during this process. Albumin did not protect against DNA damage induced by NADPH but was extremely effective at preventing DNA fragmentation arising from the suppression of glutathione peroxidase activity with mercaptosuccinate. These studies emphasize that the design of clinically effective antioxidant treatments will depend, critically, upon the source of the oxidative stress. For cases involving excessive intracellular ROS generation, albumin appears to be an important means of neutralizing lipid peroxide-mediated damage to the sperm plasma membrane and DNA.