The EVerT2 (Effective Verruca Treatments 2) trial: a randomized controlled trial of needling vs. nonsurgical debridement for the treatment of plantar verrucae.

BACKGROUND: Verrucae are a common foot skin pathology, which can in some cases persist for many years. Plantar verrucae can be unsightly and painful. There are a range of treatment options including needling. OBJECTIVES: The EVerT2 (Effective Verruca Treatments 2) trial aimed to evaluate the clinical and cost-effectiveness of the needling procedure for the treatment of plantar verrucae, relative to callus debridement. METHODS: This single-centre randomized controlled trial recruited 60 participants (aged ≥ 18 years with a plantar verruca). Participants were randomized 1 : 1 to the intervention group (needling) or the control group (debridement of the overlying callus). The primary outcome was clearance of the index verruca at 12 weeks after randomization. Secondary outcomes included recurrence of the verruca, clearance of all verrucae, number of verrucae, size of the index verruca, pain and participant satisfaction at 12 and 24 weeks. A cost-effectiveness analysis was carried out from the National Health Service perspective over 12 weeks. RESULTS: Sixty eligible patients were randomized (needling group n = 29, 48%; debridement group n = 31, 52%) and 53 were included in the primary analysis (needling n = 28, 97%; debridement n = 25, 81%). Clearance of the index verruca occurred in eight (15%) participants (needling n = 4, 14%; debridement n = 4, 16%; P = 0·86). The needling intervention costs were on average £14·33 (95% confidence interval 5·32-23·35) more per patient than for debridement. CONCLUSIONS: There is no evidence that the needling technique is more clinically or cost-effective than callus debridement. The results show a significant improvement in pain outcomes after needling compared with the debridement treatment alone.

Speech, communication and use of augmentative communication in young people with cerebral palsy: the SH&PE population study.

BACKGROUND: Communication is frequently impaired in young people (YP) with bilateral cerebral palsy (CP). Important factors include motoric speech problems (dysarthria) and intellectual disability. Augmentative and Alternative Communication (AAC) techniques are often employed. The aim was to describe the speech problems in bilateral CP, factors associated with speech problems, current AAC provision and use, and to explore the views of both the parent/carer and young person about communication. METHODS: A total population of children with bilateral CP (n = 346) from four consecutive years of births (1989-1992 inclusive) with onset of CP before 15 months were reassessed at age 16-18 years. Motor skills and speech were directly assessed and both parent/carer and the young person asked about communication and satisfaction with it. RESULTS: Sixty had died, eight had other conditions, 243 consented and speech was assessed in 224 of whom 141 (63%) had impaired speech. Fifty-two (23% of total YP) were mainly intelligible to unfamiliar people, 22 (10%) were mostly unintelligible to unfamiliar people, 67 (30%) were mostly or wholly unintelligible even to familiar adults. However, 89% of parent/carers said that they could communicate 1:1 with their young person. Of the 128 YP who could independently complete the questions, 107 (83.6%) were happy with their communication, nine (7%) neither happy nor unhappy and 12 (9.4%) unhappy. A total of 72 of 224 (32%) were provided with one or more types of AAC but in a significant number (75% of 52 recorded) AAC was not used at home, only in school. Factors associated with speech impairment were severity of physical impairment, as measured by Gross Motor Function Scale level and manipulation in the best hand, intellectual disability and current epilepsy. CONCLUSIONS: In a population representative group of YP, aged 16-18 years, with bilateral CP, 63% had impaired speech of varying severity, most had been provided with AAC but few used it at home for communication.

Management of drooling in children: a survey of UK paediatricians' clinical practice.

BACKGROUND: Drooling is common in children with disordered oral-motor control. There is little evidence about the comparative effectiveness of different interventions used to reduce the impact of drooling. Anecdotal reports suggest clinicians' management of drooling varies widely. The aims of this survey were to establish which drooling interventions are currently used, how their effectiveness is monitored and how frequently adverse effects are reported. METHODS: 151 UK paediatricians completed a questionnaire about their management of drooling. RESULTS: Paediatricians saw one new child with problematic drooling and three follow-up children per month. The most common prescribing pattern was hyoscine first line (84.7%) followed by glycopyrronium bromide second line. The reported rate of adverse effects of medications was lower than expected (median 10% for hyoscine). Very few paediatricians used standardized methods of measuring the medication's effectiveness or adverse effects. CONCLUSION: Paediatricians regularly see small numbers of children with problematic drooling. Their clinical management of drooling varies; this is most likely because of a lack of evidence about the most effective approach. Comparative trials of interventions and the development of evidence-based clinical guidelines would improve the management of children's drooling.

Management of drooling in children.

Drooling beyond the age of 4 years is neurodevelopmentally abnormal. Chronic "sialorrhoea" is seen in children with abnormal oral sensation and/or motor control and more infrequently when there is excessive production of saliva. Salivary production from the paired glands is under autonomic parasympathetic control. Management of the problem relies on multidisciplinary teams with a focus on assessment and when appropriate conservative interventions, oral motor training, dental appliances, medical and surgical treatment programs. Medically, the focus is on modifying the neuroglandular control of saliva with the use of anticholinergic agents. The article covers these areas of background, assessment and management in detail.

Pilot feasibility randomized clinical trial of negative-pressure wound therapy versus usual care in patients with surgical wounds healing by secondary intention.

BACKGROUND: Surgical wounds healing by secondary intention (SWHSI) are increasingly being treated with negative-pressure wound therapy (NPWT) despite a lack of high-quality research evidence regarding its clinical and cost-effectiveness. This pilot feasibility RCT aimed to assess the methods for and feasibility of conducting a future definitive RCT of NPWT for the treatment of SWHSI. METHODS: Eligible consenting adult patients receiving care at the study sites (2 acute and 1 community) and with a SWHSI appropriate for NPWT or wound dressing treatment were randomized 1 : 1 centrally to receive NPWT or usual care (no NPWT). Participants were followed up every 1-2 weeks for 3 months. Feasibility (recruitment rate, time to intervention delivery) and clinical (time to wound healing) outcomes were assessed. RESULTS: A total of 248 participants were screened for eligibility; 40 (16·1 per cent) were randomized, 19 to NPWT and 21 to usual care. Twenty-four of the 40 wounds were located on the foot. Participants received NPWT for a median of 18 (range 0-72) days. Two participants in the NPWT group never received the intervention and 14 received NPWT within 48 h of randomization. Five participants in the usual care group received NPWT during the study. Ten of the 40 wounds were deemed to have healed during the study. CONCLUSION: A full-scale RCT to investigate the clinical and cost-effectiveness of NPWT for SWHSI is feasible. This study identified crucial information on recruitment rates and data collection methods to consider during the design of a definitive RCT. Registration number: ISRCTN12761776 (http://www.iscrtn.com).

No difference found in time to publication by statistical significance of trial results: a methodological review.

OBJECTIVE: Time-lag from study completion to publication is a potential source of publication bias in randomised controlled trials. This study sought to update the evidence base by identifying the effect of the statistical significance of research findings on time to publication of trial results. DESIGN: Literature searches were carried out in four general medical journals from June 2013 to June 2014 inclusive (BMJ, JAMA, the Lancet and the New England Journal of Medicine). SETTING: Methodological review of four general medical journals. PARTICIPANTS: Original research articles presenting the primary analyses from phase 2, 3 and 4 parallel-group randomised controlled trials were included. MAIN OUTCOME MEASURES: Time from trial completion to publication. RESULTS: The median time from trial completion to publication was 431 days (n = 208, interquartile range 278-618). A multivariable adjusted Cox model found no statistically significant difference in time to publication for trials reporting positive or negative results (hazard ratio: 0.86, 95% CI 0.64 to 1.16, p = 0.32). CONCLUSION: In contrast to previous studies, this review did not demonstrate the presence of time-lag bias in time to publication. This may be a result of these articles being published in four high-impact general medical journals that may be more inclined to publish rapidly, whatever the findings. Further research is needed to explore the presence of time-lag bias in lower quality studies and lower impact journals.

A study of high copper amalgams. IV. Formation of eta Cu-Sn (Cu6Sn5) crystals in a high copper dispersant amalgam matrix.

In an HCD amalgam, eta Cu-Sn crystals were found dispersed within gamma1 matrix areas. Previously, eta Cu-Sn phase was thought to form only as part of a reaction zone surrounding Ag-Cu dispersant particles. The eta Cu-Sn crystals found in matrix areas of this HCD amalgam are smaller and more widely scattered than eta Cu-Sn crystals dispersed in the gamma1 matrix of HCSC amalgams.

High-temperature behavior of a Pd-Ag alloy for porcelain.

The mechanism of formation of nodular material on the surface of a Pd-Ag-based alloy for porcelain during pre-porcelainization heat treatment was investigated using scanning electron microscopy, x-ray diffraction, quantitative metallography, and Auger electron spectroscopy. The nodules were found to form by a Nabarro-Herring creep mechanism driven by the internal oxidation of tin and indium. Implications of this process with regard to porcelain bonding and discoloration are discussed.

Microstructures in non-precious alloys near the procelain-metal interaction zone.

The chemistry of microstructures near the interfacial reaction zones of four non-precious alloys and two different brands of dental porcelain has been analyzed. It was found that most non-precious dental alloys contain second phases which can alter elemental concentration profiles. Recommendations for assessing interfacial reaction zone chemistry in dental non-precious alloys are offered.

The effect of thermal history on porcelain expansion behavior.

Porcelain-fused-to-metal restorations are fixed several hundred degrees above the glass-transition temperature and cooled rapidly through the glass-transition temperature range. Thermal expansion data from room temperature to above the glass-transition temperature range are important for the thermal expansion of the porcelain to be matched to the alloy. The effect of heating rate during measurement of thermal expansion was determined for NBS SRM 710 glass and four commercial opaque and body porcelain products. Thermal expansion data were obtained at heating rates of from 3 to 30 degrees C/min after the porcelain was cooled at the same rate. By use of the Moynihan equation (where Tg systematically increases in temperature with an increase in cooling/heating rate), the glass-transition temperatures (Tg) derived from these data were shown to be related to the heating rate.

Oxide adherence and porcelain bonding to titanium and Ti-6Al-4V alloy.

The bonding of an experimental low-fusing porcelain to titanium and Ti-6Al-4V was evaluated by an x-ray spectrometric technique that measures the area that remains covered with porcelain following a controlled deformation of the metallic substrate. Oxide adherence strength values for titanium and Ti-6Al-4V oxidized at 750 degrees and 1000 degrees C were measured in tension with use of high-strength adhesives. The effect of further oxidation that would occur during porcelain firing was evaluated via simulated porcelain firings without actual porcelain application. Interface cross-sections of the titanium-porcelain and Ti-6Al-4V-porcelain bonds were examined in a scanning electron microscope (SEM). The porcelain was found to delaminate completely from the metal substrate, leaving less than 1% of the surface covered with porcelain. The oxide adherence of the specimens oxidized at 750 degrees C was good, but those oxidized at 1000 degrees C exhibited significantly lower oxide adherence (p = 0.001). The simulated porcelain-firing oxidation treatments also produced a significant decrease in oxide adherence (p = 0.004). The 750 degrees C oxidation treatments produced oxide films too thin to be visualized in the SEM, whereas the 1000 degrees C oxidation treatments produced oxide films approximately 1 micron thick. The lower oxide adherence of the 1-micron-thick oxide films is consistent with reports in the titanium literature of oxide delamination when the oxide film reaches 1 micron in thickness.

Adherence controlling elements in ceramic-metal systems. I. Precious alloys.

Elemental analysis of two precious alloyceramic systems revealed the accumulation of Sn atoms within the interaction zone of couples subjected to a range of metal oxidation time; and varying total firing times. The source of Sn atoms which accumulated within the interaction zone was the opaque porcelain layer which contained an initially higher Sn concentration than the alloy. It is hypothesized that SnO2 provides continuity of electronic structure between alloy and ceramic structures and is a primary factor in controlling ceramic-metal adherence.

Adherence controlling elements in ceramic-metal systems. II. Nonprecious alloys.

Nickel-chromium alloy-ceramic couples used in this study exhibited Cr, Ni-Cr, and Ti-Cr interactions with bonding agent-ceramic complexes. Bonding agents may broaden or suppress the width of interaction zones. Metal oxides such as NiO, Cr2O3, or more complex forms such as TiO-Cr2O3 and NiCr2O4 may play a prominent role in controlling ceramic-metal adherence.

New information on high copper amalgam corrosion.

Anodic polarization of "pure" Cu6Sn5 was investigated. Cu6Sn5 is found to be passive in nearly neutral synthetic saliva. Anodic corrosion activity (characteristic for tin) previously reported for a high copper amalgam must result from the presence of the gamma2 phase or tin in the matrix phase.

A study of high copper amalgams. II. Amalgamation on a Hg-plated high copper alloy containing 30 wt% Cu.

The amalgamation reaction of a low silver, high copper alloy powder has been investigated by plating tablets of compacted powder with Hg. Both gamma1 Ag-Hg and micro Cu-Sn crystals form on the tablets. In spite of large differences in composition, these tablets amalgamated similarly to the T tablets studied and reported in Part I.

Comparative evaluation of ceramic-metal bond tests using finite element stress analysis.

Eleven porcelain-fused-to-metal bond tests were analyzed for interfacial shear stress distribution using finite-element stress analysis. Stress concentration effects are significant in ten of the 11 tests. A high probability of tensile failure within porcelain or the interfacial region was found in eight of the 11 tests analyzed.

An x-ray spectrometric technique for measuring porcelain-metal adherence.

This study demonstrated a correlation between silicon x-ray counts and area fractions of adherent porcelain as determined by point-counting. This correlation has allowed a method to be devised for measuring area fractions of porcelain adherent to porcelain-fused-to-metal (PFM) fracture surfaces. The described method, after controlled destruction of the porcelain mass, uses silicon x-rays excited by the electron beam in a scanning electron microscope. Under the conditions employed in these studies, the x-ray technique has shown that this gold alloy retains more porcelain than does either of two particular nickel-chromium alloys.

Fatigue of dental ceramics in a simulated oral environment.

Fatigue in ceramics refers to the subcritical growth of cracks, aided by the combined influence of water and stress. The dynamic fatigue (constant stressing rate) method was used to obtain subcritical crack growth parameters for three dental ceramics: a feldspathic porcelain, an aluminous porcelain, and a fine-grain, polycrystalline core material. The constant stressing rate experiments were carried out at 37 degrees C for all three ceramics in distilled water, and, for the feldspathic porcelain, in artificial saliva as well. Considerable differences were found in the value of the crack growth exponent (n) among the three ceramics. The feldspathic porcelain was lowest in n-value, while the fine-grain ceramic had the highest n-value. No differences were found for the feldspathic porcelain with respect to n measured in water and in the artificial saliva. Lifetime prediction curves in 37 degrees C water, constructed from the n-values and inert strengths, showed that fatigue failure within five years is a good possibility for feldspathic porcelain specimens at stress levels which can reasonably be anticipated to occur in the oral environment. Little likelihood of failure was perceived for the fine-grain ceramic. The aluminous porcelain was intermediate between these two materials with respect to failure probability.

Measurement of oxide adherence to PFM alloys.

A method has been reported for evaluating adherence of an oxide to its substrate metal to a maximum value of about 40 MPa. Oxidized alloy plates were cemented between two aluminum cylinders with a high-strength cyanoacrylate cement and loaded in tension until failure occurred either at the oxide/metal interface, within the oxide layer, or in the cement itself. Significant differences were found among the oxide adherence values obtained from different PFM alloys. The oxides formed on five of the alloys exhibited adherence strengths in excess of the published value for cohesive strength of dental opaque porcelain, indicating that they possess sufficient adherence to act as the transition zone between the porcelain and the alloy. In addition, a correspondence was found between the quality of porcelain bond for a given alloy and its oxide adherence strength. These results remove the principal objection to the oxide-layer theory of porcelain bonding in dental alloy systems and emphasize the importance of oxide adherence in the establishment of a bond. It is therefore suggested that future work devoted to porcelain-metal bonding should seek to elucidate the mechanism of oxide adherence to PFM alloys and explore the development of new alloys which form adherent oxides.

A rapid heating and cooling rate dilatometer for measuring thermal expansion in dental porcelain.

Herein we describe a dilatometer that consists of a low-mass infrared furnace for rapid heating or cooling, an optical pyrometer, and a laser interferometer. The dilatometer facilitates observations of thermal expansion at rates comparable with those in dental laboratory practice over the temperature range necessary for comparison of thermal expansion of dental porcelain and alloy. Examples of thermal expansion data obtained at a 600 degrees C/min heating rate on NIST SRM 710 glass and dental porcelain are reported. To a limited extent, thermal expansion data above the glass-transition temperature range of dental porcelain were obtained. A shift of the glass-transition temperature range to higher temperatures was observed for both materials, compared with data obtained at 20 degrees C/min.