Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo.

BACKGROUND: Symptoms arising from vestibular system dysfunction are observed in 49-59% of people with Multiple Sclerosis (MS). Symptoms may include vertigo, dizziness and/or imbalance. These impact on functional ability, contribute to falls and significant health and social care costs. In people with MS, vestibular dysfunction can be due to peripheral pathology that may include Benign Paroxysmal Positional Vertigo (BPPV), as well as central or combined pathology. Vestibular symptoms may be treated with vestibular rehabilitation (VR), and with repositioning manoeuvres in the case of BPPV. However, there is a paucity of evidence about the rate and degree of symptom recovery with VR for people with MS and vestibulopathy. In addition, given the multiplicity of symptoms and underpinning vestibular pathologies often seen in people with MS, a customised VR approach may be more clinically appropriate and cost effective than generic booklet-based approaches. Likewise, BPPV should be identified and treated appropriately. METHODS/ DESIGN: People with MS and symptoms of vertigo, dizziness and/or imbalance will be screened for central and/or peripheral vestibulopathy and/or BPPV. Following consent, people with BPPV will be treated with re-positioning manoeuvres over 1-3 sessions and followed up at 6 and 12 months to assess for any re-occurrence of BPPV. People with central and/or peripheral vestibulopathy will be entered into a randomised controlled trial (RCT). Trial participants will be randomly allocated (1:1) to either a 12-week generic booklet-based home programme with telephone support or a 12-week VR programme consisting of customised treatment including 12 face-to-face sessions and a home exercise programme. Customised or booklet-based interventions will start 2 weeks after randomisation and all trial participants will be followed up 14 and 26 weeks from randomisation. The primary clinical outcome is the Dizziness Handicap Inventory at 26 weeks and the primary economic endpoint is quality-adjusted life-years. A range of secondary outcomes associated with vestibular function will be used. DISCUSSION: If customised VR is demonstrated to be clinically and cost-effective compared to generic booklet-based VR this will inform practice guidelines and the development of training packages for therapists in the diagnosis and treatment of vestibulopathy in people with MS. TRIAL REGISTRATION: ISRCTN Number: 27374299 Date of Registration 24/09/2018 Protocol Version 15 25/09/2019.

The impact of emergency department patient-controlled analgesia (PCA) on the incidence of chronic pain following trauma and non-traumatic abdominal pain.

The effect of patient-controlled analgesia during the emergency phase of care on the prevalence of persistent pain is unkown. We studied individuals with traumatic injuries or abdominal pain 6 months after hospital admission via the emergency department using an opportunistic observational study design. This was conducted using postal questionnaires that were sent to participants recruited to the multi-centre pain solutions in the emergency setting study. Patients with prior chronic pain states or opioid use were not studied. Questionnaires included the EQ5D, the Brief Pain Inventory and the Hospital Anxiety and Depression scale. Overall, 141 out of 286 (49% 95%CI 44-56%) patients were included in this follow-up study. Participants presenting with trauma were more likely to develop persistent pain than those presenting with abdominal pain, 45 out of 64 (70%) vs. 24 out of 77 (31%); 95%CI 24-54%, p < 0.001. There were no statistically significant associations between persistent pain and analgesic modality during hospital admission, age or sex. Across both abdominal pain and traumatic injury groups, participants with persistent pain had lower EQ5D mobility scores, worse overall health and higher anxiety and depression scores (p < 0.05). In the abdominal pain group, 13 out of 50 (26%) patients using patient-controlled analgesia developed persistent pain vs. 11 out of 27 (41%) of those with usual treatment; 95%CI for difference (control - patient-controlled analgesia) -8 to 39%, p = 0.183. Acute pain scores at the time of hospital admission were higher in participants who developed persistent pain; 95%CI 0.7-23.6, p = 0.039. For traumatic pain, 25 out of 35 (71%) patients given patient-controlled analgesia developed persistent pain vs. 20 out of 29 (69%) patients with usual treatment; 95%CI -30 to 24%, p = 0.830. Persistent pain is common 6 months after hospital admission, particularly following trauma. The study findings suggest that it may be possible to reduce persistent pain (at least in patients with abdominal pain) by delivering better acute pain management. Further research is needed to confirm this hypothesis.

The cost-effectiveness of patient-controlled analgesia vs. standard care in patients presenting to the Emergency Department in pain, who are subsequently admitted to hospital.

The clinical effectiveness of patient-controlled analgesia has been demonstrated in a variety of settings. However, patient-controlled analgesia is rarely utilised in the Emergency Department. The aim of this study was to compare the cost-effectiveness of patient-controlled analgesia vs. standard care in participants admitted to hospital from the Emergency Department with pain due to traumatic injury or non-traumatic abdominal pain. Pain scores were measured hourly for 12 h using a visual analogue scale. Cost-effectiveness was measured as the additional cost per hour in moderate to severe pain avoided by using patient-controlled analgesia rather than standard care (the incremental cost-effectiveness ratio). Sampling variation was estimated using bootstrap methods and the effects of parameter uncertainty explored in a sensitivity analysis. The cost per hour in moderate or severe pain averted was estimated as £24.77 (€29.05, US$30.80) (bootstrap estimated 95%CI £8.72 to £89.17) for participants suffering pain from traumatic injuries and £15.17 (€17.79, US$18.86) (bootstrap estimate 95%CI £9.03 to £46.00) for participants with non-traumatic abdominal pain. Overall costs were higher with patient-controlled analgesia than standard care in both groups: pain from traumatic injuries incurred an additional £18.58 (€21.79 US$23.10) (95%CI £15.81 to £21.35) per 12 h; and non-traumatic abdominal pain an additional £20.18 (€23.67 US$25.09) (95%CI £19.45 to £20.84) per 12 h.

Standing up in multiple sclerosis (SUMS): protocol for a multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of a home-based self-management standing frame programme in people with progressive multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is an incurable, unpredictable but typically progressive neurological condition. It is the most common cause of neurological disability in young adults. Within 15 years of diagnosis, approximately 50 % of affected people are unable to walk unaided, and over time an estimated 25 % depend on a wheelchair. Typically, people with such limited mobility are excluded from clinical trials. Severely impaired people with MS spend much of their day sitting, often with limited ability to change position. In response, secondary complications can occur including: muscle wasting, pain, reduced skin integrity, spasms, limb stiffness, constipation, and associated psychosocial problems such as depression and lowered self-esteem. Effective self-management strategies, which can be implemented relatively easily and cheaply within people's homes, are needed to improve or maintain mobility and reduce sedentary behaviour. However this is challenging, particularly in the latter stages of disease. Regular supported standing using standing frames is one potential option. METHODS/DESIGN: SUMS is a pragmatic multi-centre randomised controlled trial evaluating use of Oswestry standing frames with blinded outcome assessment and full economic evaluation. Participants will be randomly allocated (1:1) to either a home-based, self-management standing programme (with advice and support) along with their usual care or to usual care alone. Those in the intervention group will be asked to stand for a minimum of 30 min three times weekly over 20 weeks. Each participant will be followed-up at 20 and 36 weeks post baseline. The primary clinical outcome is motor function, assessed using the Amended Motor Club Assessment. The primary economic endpoint is quality-adjusted life years. The secondary outcomes include measures of explanatory physical impairments, key clinical outcomes, and health-related quality of life. An embedded qualitative component will explore participant's and carer's experiences of the standing programme. DISCUSSION: This is the first large scale multi-centre trial to assess the clinical and cost effectiveness of a home based standing frame programme for people who are severely impaired by MS. If demonstrated to be effective and cost-effective, we will use this evidence to develop recommendations for a health service delivery model which could be implemented across the United Kingdom. TRIAL REGISTRATION: ISRCTN69614598 DATE OF REGISTRATION: 3.2.16 (retrospectively registered).

Randomized controlled trial of stroke volume optimization during elective major abdominal surgery in patients stratified by aerobic fitness.

BACKGROUND: The benefits of stroke volume optimization during surgery are unclear, with recent data not replicating the positive effects of earlier studies. METHODS: This was a randomized controlled trial of standard fluid therapy with or without supplementary blinded intraoperative stroke volume optimization in 220 patients having major elective rectal resection or cystectomy with ileal conduit. All patients were treated using a contemporary enhanced recovery pathway. Interventional fluid challenges used Gelofusine (B Braun, Germany), guided by stoke volume variability measured by LiDCOrapid (LiDCO, UK). Participants were stratified by aerobic fitness (characterized by preoperative cardiopulmonary exercise test), surgical specialty, and intended surgical approach (open or laparoscopic). The primary outcome was the prevalence of moderate or severe complications on day 5 after surgery, defined using the postoperative morbidity survey (POMS) criteria. RESULTS: Patients received ∼13 ml kg(-1) h(-1) of i.v. fluids during surgery. The intervention group received an additional mean (sd) 956 (896) ml Gelofusine. There were no statistically significant differences between groups in any primary or secondary end point. A positive POMS on postoperative day 5 was noted in 54 of 111 control subjects (48.6%) and 55 of 109 participants in the intervention group [50.5%; adjusted odds ratio 0.90 (95% confidence interval 0.52-1.57), P=0.717]. Mean (sd) hospital length of stay was 9.6 (6.8) days in the control group and 11.8 (11.5) days in the intervention group (adjusted difference -2.1 (-4.6 to 0.3) days, P=0.091). There was no statistical interaction between stroke volume optimization and aerobic fitness in terms of rate of complications or length of stay. CONCLUSIONS: Algorithm-driven stroke volume optimization is of no benefit when superimposed on a liberal baseline fluid regimen in patients having elective major abdominal surgery, when stratified to minimize differences in fitness and surgical approach between groups. CLINICAL TRIAL REGISTRATION: ISRCTN21597243.

Patients' inability to perform a preoperative cardiopulmonary exercise test or demonstrate an anaerobic threshold is associated with inferior outcomes after major colorectal surgery.

BACKGROUND: Surgical patients with poor functional capacity, determined by oxygen consumption at anaerobic threshold (AT) during cardiopulmonary exercise testing (CPET), experience longer hospital stays and worse short- and medium-term survival. However, previous studies excluded patients who were unable to perform a CPET or who failed to demonstrate an AT. We hypothesized that such patients are at risk of inferior outcomes after elective surgery. METHODS: All patients undergoing major colorectal surgery attempted CPET to assist in the planning of care. Patients were stratified by their test results into Fit (AT ≥ 11.0 ml O2 kg(-1) min(-1)), Unfit (AT < 11.0 ml O2 kg(-1) min(-1)), or Unable to CPET groups (failed to pedal or demonstrate an AT). For each group, we determined hospital stay and mortality. RESULTS: Between March 2009 and April 2010, 269 consecutive patients were screened, and proceeded to bowel resection. Median hospital stay was 8 days (IQR 5.1-13.4) and there were 44 deaths (16%) at 2 yr; 26 (9.7%) patients were categorized as Unable to CPET, 69 (25.7%) Unfit and 174 (64.7%) Fit. There were statistically significant differences between the three groups in hospital stay [median (IQR) 14.0 (10.5-23.8) vs 9.9 (5.5-15) vs 7.1 (4.9-10.8) days, P < 0.01] and mortality at 2 yr [11/26 (42%) vs 14/69 (20%) vs 19/174 (11%), respectively (P < 0.01)] although the differences between Unable and Unfit were not statistically different. CONCLUSIONS: Patients' inability to perform CPET is associated with inferior outcomes after major colorectal surgery. Future studies evaluating CPET in risk assessment for major surgery should report outcomes for this subgroup.

Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme.

BACKGROUND: Balance, mobility impairments and falls are problematic for people with multiple sclerosis (MS). The "Balance Right in MS (BRiMS)" intervention, a 13-week home and group-based exercise and education programme, aims to improve balance and minimise falls. This study aimed to evaluate the feasibility of undertaking a multi-centre randomised controlled trial and to collect the necessary data to design a definitive trial. METHODS: This randomised controlled feasibility study recruited from four United Kingdom NHS clinical neurology services. Patients ≥ 18 years with secondary progressive MS (Expanded Disability Status Scale 4 to 7) reporting more than two falls in the preceding 6 months were recruited. Participants were block-randomised to either a manualised 13-week education and exercise programme (BRiMS) plus usual care, or usual care alone. Feasibility assessment evaluated recruitment and retention rates, adherence to group assignment and data completeness. Proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls) and economic data were collected at baseline, 13 and 27 weeks, and participants completed daily paper falls diaries. RESULTS: Fifty-six participants (mean age 59.7 years, 66% female, median EDSS 6.0) were recruited in 5 months; 30 randomised to the intervention group. Ten (18%) participants withdrew, 7 from the intervention group. Two additional participants were lost to follow up at the final assessment point. Completion rates were > 98% for all outcomes apart from the falls diary (return rate 62%). After adjusting for baseline score, mean intervention-usual care between-group differences for the potential primary outcomes at week 27 were MS Walking Scale-12v2: - 7.7 (95% confidence interval [CI] - 17.2 to 1.8) and MS Impact Scale-29v2: physical 0.6 (CI - 7.8 to 9), psychological - 0.4 (CI - 9.9 to 9). In total, 715 falls were reported, rate ratio (intervention:usual care) for falls 0.81 (0.41 to 2.26) and injurious falls 0.44 (0.41 to 2.23). CONCLUSIONS: Procedures were practical, and retention, programme engagement and outcome completion rates satisfied a priori progression criteria. Challenges were experienced in completion and return of daily falls diaries. Refinement of methods for reporting falls is therefore required, but we consider a full trial to be feasible. TRIAL REGISTRATION: ISRCTN13587999 Date of registration: 29 September 2016.

Physical activity and the prevention, reduction, and treatment of alcohol and other drug use across the lifespan (The PHASE review): A systematic review.

The aim of this review is to systematically describe and quantify the effects of PA interventions on alcohol and other drug use outcomes, and to identify any apparent effect of PA dose and type, possible mechanisms of effect, and any other aspect of intervention delivery (e.g. key behaviour change processes), within a framework to inform the design and evaluation of future interventions. Systematic searches were designed to identify published and grey literature on the role of PA for reducing the risk of progression to alcohol and other drug use (PREVENTION), supporting individuals to reduce alcohol and other drug use for harm reduction (REDUCTION), and promote abstinence and relapse prevention during and after treatment of alcohol and other drug use (TREATMENT). Searches identified 49,518 records, with 49,342 excluded on title and abstract. We screened 176 full text articles from which we included 32 studies in 32 papers with quantitative results of relevance to this review. Meta-analysis of two studies showed a significant effect of PA on prevention of alcohol initiation (risk ratio [RR]: 0.72, 95%CI: 0.61 to 0.85). Meta-analysis of four studies showed no clear evidence for an effect of PA on alcohol consumption (Standardised Mean Difference [SMD]: 0.19, 95%, Confidence Interval -0.57 to 0.18). We were unable to quantitatively examine the effects of PA interventions on other drug use alone, or in combination with alcohol use, for prevention, reduction or treatment. Among the 19 treatment studies with an alcohol and other drug use outcome, there was a trend for promising short-term effect but with limited information about intervention fidelity and exercise dose, there was a moderate to high risk of bias. We identified no studies reporting the cost-effectiveness of interventions. More rigorous and well-designed research is needed. Our novel approach to the review provides a clearer guide to achieve this in future research questions addressed to inform policy and practice for different populations and settings.

A prospective study of causes of haemolysis during venepuncture: tourniquet time should be kept to a minimum.

BACKGROUND: Haemolysis is defined as the release of cellular components of erythrocytes and other blood cells into the extracellular space of blood. These cellular components can cause interference in laboratory measurements, potassium being a commonly measured analyte to be affected. A number of factors have been implicated in the aetiology of haemolysis. We undertook this study to enable us to identify and hence rectify causes of haemolysis in samples from patients on acute medical and surgical wards. METHODS: We performed a prospective study of 353 blood sampling events during February and March 2007. A proforma was used to obtain detailed information of each blood-taking episode. Information from the proforma was linked to the incidence of haemolysis obtained from the hospital computer system. RESULTS: The incidence of haemolysis among the samples studied was 6.5%. While staff group, method of sampling, tourniquet time and number of attempts at venepuncture were each univariately associated with haemolysis, stepwise logistic regression resulted in a final model which only included tourniquet time (odds ratio for haemolysis if tourniquet time >1 min was 19.5 [95% confidence interval [CI] 5.6-67.4%]). CONCLUSION: Tourniquet time of more than a minute is associated with a significant increase in risk of haemolysis. Advice on tourniquet time is included in phlebotomy training within the hospital; hence a campaign of appropriately channelled continuing education on this issue may be successful in reducing the haemolysis rate.

Contemporary dental practice in the UK. Part 1: demography and practising arrangements in 2015.

Objectives: To determine, by means of an anonymous, self-reported questionnaire, the demographic profile and practising details of general dental practitioners in the UK in 2015. Methods: A previously-piloted and validated 121-question questionnaire was distributed during 2015 to 500 dentists at UK dental meetings with a request that they complete the questionnaire and return it by post in the reply-paid envelope to the corresponding author. Results: Three hundred and eighty-eight useable questionnaires were returned, giving aresponse rate of 77.6%. Of the respondents, 60.2% were male and 39.8% female. Theirmean age since graduation was 19.7 years. Just over half of the respondents (50.9%) replied that they were practice principals, 35.8% were associates and 10.6% were foundation dentists. A quarter of the respondents were in single-handed practices, the remainder being in a partnership or group practice. There was a mean of 4.2 dentists per practice, while the mean number of dental therapists in each practice was 0.3 and 1.2 hygienists. Regarding the first available NHS appointment in the respondents' practices for non-urgent care, 23.4% could provide this on the same day, the equivalent figure for private care being 40.1%. The mean percentage of patients receiving NHS treatment was 50%, with 33.8% receiving private treatment. Just over half of respondents considered that Care Quality Commission inspections were 'valuable for fostering patient trust and confidence in dental care.' The collected data indicated that 55.4% of respondents had an intra-oral camera, while, with regard to recently-introduced concepts and techniques, 80.4% used nickel-titanium files, 47.4% used zirconia-based bridgework and 24.9% used tricalcium silicate. Of great interest, perhaps, is the response to digital radiography/digital imaging, with the results indicating that 74.1% of respondents used this form of radiography. Regarding checking the light output of the light curing units, 53.1% stated that they did check the output, but in some cases this might be at a six-monthly interval. Conclusion: Results from this survey indicated that NHS service provision has dropped toapproximately 50% amongst the respondents. Regarding the staffing of dentalpractices, just over half the respondents were practice principals and there was a mean of 4.2 dentists per practice. The results also indicated that UK dentists continue to be innovative in the techniques that they employ.

Dental practice in the UK in 2015/2016. Part 3: aspects of indirect restorations and fixed prosthodontics.

Objective: This paper reports data which helps identify changes and trends in the provision of indirect fixed prostheses in general dental practice in the UK. To determine by means of an anonymous, self-report questionnaire, the current trend in the provision of fixed prosthodontic treatments, with a special emphasis on the choice of treatment modalities, techniques and materials. Methods: The data presented were extracted from the data obtained from a validated,121-question questionnaire distributed at random to general dental practitioners in the UK attending postgraduate meetings in 2015/2016, with a wide distribution of locations. Results: A response rate exceeding 66% was achieved. Amalgam and light-cured composite were the preferred material for core build-up of vital teeth for around 62% of the respondents. Dentine pins were still being used by 66% of the respondents. The vast majority of respondents (92%) used a post and core to restore root-treated teeth. Fibre posts were the most commonly used (63%) type of preformed post among the respondents. Using the opposing and adjacent teeth as a reference to control tooth structure reduction during vital tooth preparation was the most common method, used by 42% of the respondents. Addition-cured silicone impression materials were the most frequently used impression material (78%). The surveyed practitioners were equally split between precious and non-precious metals as the substructure for indirect restorations. Glass-ionomer luting cements (47%) and resin-based cements (52%) were the most commonly used to cement porcelain fused to metal and zirconia indirect restorations, respectively. Laboratory made aesthetic veneers were prescribed by half of the respondents, while a third of them preferred direct resin composite as a veneer material. Conclusion: Within the limitations of the study, it was concluded that there has been an increase in the use of adhesive bonding and metal-free restorations. Amalgam and dentine pinscontinued to be used, contrary to international trends. Studies of the type reported are considered important in investigating trends and developments in dentistry.

The permeability of artificial dentine carious lesions.

OBJECTIVE: This study aimed to verify whether two demineralisation solutions, with different fluoride concentrations, would produce subsurface lesions in dentine, as assessed by microradiography, with different mineral loss profiles and, subsequently, to determine the dentine permeability of the two altered tissues. METHODS: Forty-five human coronal portions were prepared and randomly divided into two test groups (20 specimens each) with the remaining five as a control group. Each test group was exposed to a demineralisation solution containing either 1 or 5 ppm fluoride for five days. RESULTS: There were highly significant differences between the two test groups for all microradiographic parameters, except for lesion depth. The increase in dentine permeability from baseline to day 5 was statistically significant within each of the two test groups, but not for the control group. CONCLUSION: The differences in the mineral content profile of the two lesions did not influence the magnitude of change in their permeability.

A randomised, observer-blind, clinical study investigating the effect of fluoridated milk on artificially created early enamel caries using transverse microradiography.

Much of the research regarding the efficacy of fluoridated milk was obtained prior to the routine use of fluoridated dentifrices. The aim was to investigate, in situ, the effect of fluoridated and non-fluoridated milk on mineral change in artificial caries lesions, with the additional use of fluoridated dentifrice. The roles of different milk fluoride concentrations, volumes and frequencies in mineral change were studied. In total, 29 edentulous subjects were recruited and tooth blocks, containing artificial caries lesions, were inserted into their full dentures at 4 areas (sites). Each subject followed 5 randomly ordered, 6-week beverage experiments: 0.5 mg of F in 200 ml of milk, 3 times per day; 1.5 mg of F in 200 ml of milk, once per day; 200 ml of milk, once per day; 200 ml of milk, 3 times per day, and no beverage (negative control). In addition, the subjects were allocated to 1 of 2 groups; experimental treatment only or treatment and dentifrice. Mineral change was measured with transverse microradiography. Statistical analysis was performed using 2-sample t tests and a general linear modelling procedure. For integrated mineral loss there was a statistically significant effect of group (p = 0.001), indicating fluoridated toothpaste significantly increased remineralisation. For lesion depth there was a statistically significant combined effect of 'group and site'. 'Experiment' had no statistically significant influence on change in integrated mineral loss or lesion depth. The study demonstrated that the use of fluoridated dentifrice twice per day had a positive effect on the remineralisation of caries lesions. However, no additional significant effect of fluoridated milk was observed.

Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial.

BACKGROUND: Impaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels are significantly compromised; an estimated 70% of people with secondary progressive MS fall regularly. Our ongoing research has systematically developed 'Balance Right in MS' (BRiMS), an innovative, manualised 13-week guided self-management programme tailored to the needs of people with MS, designed to improve safe mobility and minimise falls. Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in people with secondary progressive MS by undertaking an appropriately statistically powered, multi-centre, assessor-blinded definitive, randomised controlled trial. This feasibility study will assess the acceptability of the intervention and test the achievability of running such a definitive trial. METHODS/DESIGN: This is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation. The outcomes of this feasibility trial include:Feasibility outcomes, including trial recruitment, retention and completionAssessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level)Measures of adherence to the BRiMS programmeData to inform the economic evaluation in a future trialProcess evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience). DISCUSSION: The BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several uncertainties which need to be addressed prior to progressing to a full-scale trial, including acceptability of the BRiMS intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties and will enable a protocol to be finalised for use in the definitive trial. TRIAL REGISTRATION: ISRCTN13587999.

Use of a composite pedicled muscle flap and rhBMP-7 for mandibular reconstruction.

The aim of this study was to investigate the feasibility of reconstructing critical size continuity osteoperiosteal defects of the mandible using a composite of recombinant BMP-7 contained in a bovine type-1 collagen carrier wrapped in a pedicled sterno-occipitalis muscle flap. At 3 months following surgery, bridging of the surgical defect was noted in three subjects (60%). Histologically, the induced bone regenerate showed maturation from woven to lamellar bone. Islands of cartilage were distributed throughout the defect. Replacement ossification of the degenerated muscle was a common feature in all specimens. Microradiography showed a gradual increase in the calcification of mineralized tissue from the margin to the centre of the newly generated bone. This research represents a proof of the concept that bone can be satisfactorily formed within a muscular scaffolding at the site of the created defect in a one-stage procedure.

The effect of baseline lesion mineral loss on in situ remineralization.

The effect of baseline lesion mineral loss on the remineralization of enamel lesions by a sodium fluoride dentifrice was studied in situ by means of an appliance carrying enamel sections. Artificial lesions of various sizes were created, by means of acidified gelatin, and were then mounted on the appliances of five volunteers. Each brushed twice daily for two min with a 1000 ppm F sodium fluoride dentifrice. Measurements of mineral content were made at baseline and at weekly intervals by microradiographic/microdensitometric techniques. Data from all five volunteers showed a linear increase in remineralization rate with increasing lesion size. Thus, in studies which compare the effects of different remineralizing formulations, care must be taken to ensure that initial lesion sizes are matched, or that the results are expressed as a percentage change in mineral content.

The effect of chewing gum use on in situ enamel lesion remineralization.

Two independent cross-over studies investigated the possibility of enhanced early enamel lesion remineralization with the use of chewing gum. The first study involved a sorbitol-containing chewing gum, and the second, which had an identical protocol, tested a sucrose-containing chewing gum. In each study, 12 volunteers wore in situ appliances on which were mounted enamel sections containing artificial caries lesions. Subjects brushed twice daily for two min with a 1100-ppm-F (NaF) dentifrice (control and test) and in the test phase chewed five sticks of gum per day for 20 min after meals and snacks. Microradiographs of the enamel lesions were made at baseline and at the end of the seven-week experimental period. In the sugar-free gum study, the weighted mean total mineral loss (delta z) difference [(wk7-wk0) x (-1)] was 788 vol.% min. x micron for the gum, corresponding to remineralization of 18.2%, vs. the control value of 526 vol.% min. x micron, 12.1% remineralization (p = 0.07). There were no significant differences for the surface-zone (p = 0.20) and lesion-body (p = 0.28) values. In the sucrose-containing gum study, the delta z difference was 743 vol.% min. x micron for the gum, corresponding to a remineralization of 18.3%, vs. the control value of 438 vol.% min. x micron, 10.8% remineralization (p = 0.08). The surface-zone values were not significantly different (p = 0.55). For the lesion body, however, the sucrose-containing gum value of 6.11 vol.% min. was significantly different (p = 0.01) from that of the control (2.81 vol.% min.).

Comparison of fibre optic transillumination with clinical and radiographic caries diagnosis.

Fibre optic transillumination (FOTI) has been employed during the course of a 3-yr clinical dentifrice trial which initially involved 3003 children. At the initial examination, a subgroup of 813 13-yr-olds, and at the following annual visit, 2247 14-yr-olds, were examined using a 150 W lamp and 0.5 mm diameter probe. Routine clinical and radiographic examinations were performed separately. Compared to the clinical scores for anterior teeth, FOTI detected an additional 64% of interproximal lesions at the first visit while, for the larger number of children at the second visit, the increase in lesion detection level using FOTI was 37%. For the posterior teeth the comparable figure at the second examination was 92%. When FOTI data were compared to radiographic data for more than 52,000 posterior interproximal surfaces, FOTI could only detect 17% of radiographic Grade 2 lesions and 48% Grade 3 lesions. Thus any assumption that FOTI diagnoses may be a substitute for bitewing radiography appears premature.

A 3-year oral health dose-response study of sodium monofluorophosphate dentifrices with and without zinc citrate: anti-caries results.

A 3-yr clinical trial has been conducted on 3000 12-yr-old children in Lanarkshire, Scotland, with the aim of investigating the effects on oral health of toothpastes containing both sodium monofluorophosphate and zinc citrate, the former being present at fluoride levels of 1000, 1500, and 2500 ppm F. No significant difference in caries increments was found between the group of children using toothpastes incorporating zinc citrate and their counterparts using zinc-free pastes. However, a significant anti-caries dose-response was demonstrated over the SMFP range used. This dose-response was evident for boys and girls and also for the various types of teeth and tooth surfaces.

The pH and titratable acidity of a range of diluting drinks and their potential effect on dental erosion.

OBJECTIVES: To investigate, in vitro, the potential dental effects of diluting juices by measuring their acidity levels and to examine the effect dilution has on the potential erosive properties of the drinks. METHODS: Four commonly available diluting drinks were assessed for both pH and titratable acidity at a variety of dilutions, reflecting the range of concentrations over which such drinks may be consumed. Predetermined dilutions of citric acid and hydrochloric acid, with similar pH values to those of the drinks, were used as positive control acidic solutions. The pH measurements throughout the study were made using a pH electrode connected to an Orion EA940 IonAnalyser. RESULTS: All four drinks demonstrated a high degree of resistance to a rise in pH, indicating high intrinsic buffering capacity. The measured pH changed very little with increasing dilution ratio when compared to the citric and hydrochloric acid controls, even when considered extremely dilute. In contrast, the titratable acidity of each of the drinks reduced proportionally with increasing dilution, thereby reducing considerably its erosive potential. CONCLUSIONS: While dilution had very little effect on the measured pH values, the titratable acidity reduced as the drink became more dilute. Since there appears to be a direct relationship between dilution and titratable acidity, the erosive potential of diluting juices may be reduced substantially by the addition of water. It remains unlikely, however, that the drinks would ever be consumed at a 'safe' level of dilution due to diminished taste and colour.