Randomized controlled trial to study plaque inhibition in calcium sodium phosphosilicate dentifrices

Objectives To evaluate the effect of three calcium sodium phosphosilicate (CSPS)/sodium monofluorophosphate containing dentifrices, compared to positive and negative controls on plaque re-growth in a non-brushing model, after 4 days of twice daily use, as determined by plaque area and Turesky plaque index (TPI). Methods This was an exploratory, single-centre, examiner-blind, randomised, controlled, five treatment period, crossover, plaque re-growth study, with supervised use of study products. Twenty-three healthy adult volunteers were randomized to receive experimental 5% CSPS dentifrice; two marketed 5% CSPS dentifrices; active comparator mouthrinse and negative control dentifrice. At the start of each treatment period, zero plaque was established by dental prophylaxis and study products were dispensed as either dentifrice slurries or mouthrinse, twice daily for the next 4 days. No other forms of oral hygiene were permitted. After 96 h, supra-gingival plaque was determined by plaque area (direct entry, planimetric method) and TPI. Changes from zero plaque were analysed. Results For both measures, plaque re-growth at 96 h was significantly lower following treatment with active comparator mouthrinse and significantly higher following treatment with the experimental 5% CSPS dentifrice, compared to all other treatments. There were no statistically significant differences between the three other treatments, except between the marketed 5% CSPS dentifrices, for overall plaque area. Conclusions The comparator mouthwash was significantly more effective at preventing plaque accumulation than the dentifrice slurries. The three marketed dentifrices contained sodium lauryl sulphate and were more effective at reducing plaque re-growth than the experimental dentifrice formulated with a tegobetaine/adinol surfactant system. Clinical relevance The CSPS containing dentifrices tested in this study showed no significant chemical-therapeutic anti-plaque benefits compared to a negative control dentifrice. However, sodium lauryl sulphate-containing dentifrices controlled plaque more effectively than a tegobetaine/adinol-containing CSPS dentifrice suggesting that the impact of surfactant selection on anti-plaque activity of formulations warrants further investigation

PREHAB FAI- Prehabilitation for patients undergoing arthroscopic hip surgery for Femoroacetabular Impingement Syndrome -Protocol for an assessor blinded randomised controlled feasibility study.

BackgroundThe past decade has seen an exponential growth of minimally invasive surgical procedures. Procedures such as hip arthroscopy have rapidly grown and become the standard of care for patients with Femoroacetabular Impingement Syndrome (FAIS). Although, the results of such procedures are encouraging, a large proportion of patients do not achieve optimal outcomes due to chronicity and deconditioning as a result of delay in diagnosis and increased waiting times amongst other factors. In a recent systematic review and meta-analysis of randomised control trials, moderate certainty evidence supported prehabilitation over standard care in optimising several domains including muscle strength, pain and health related quality of life in patients undergoing orthopaedic surgical interventions. However, the role of prehabilitation in patients with FAI syndrome undergoing hip arthroscopy has received little attention.AimTo evaluate the feasibility, suitability, acceptability and safety of a prehabilitation programme for FAI to inform a future definitive randomised control trial to assess effectiveness.MethodsA systematically developed prehabilitation intervention based on a literature review and international consensus will be utilised in this study. A mixed methodology encompassing a two-arm randomised parallel study alongside an embedded qualitative component will be used to answer the study objectives. Patients will be recruited from a tertiary referral NHS centre for young adult hip pathology in the UK. Patient reported outcomes such as iHOT-12, Brief Pain Inventory Scale (Short form), Hospital Anxiety and Depression Scale and Patient Global Impression of Change score will be obtained alongside objective measurements such as Muscle Strength and Star Excursion Balance Test at various time points. Outcome measures will be obtained at baseline (prior to prehabilitation intervention), after prehabilitation before surgery, and at 6 weeks+/- 4 weeks and 6 months +/- 4 weeks (planned primary endpoint for definitive RCT) postoperatively when participants attend the research site for clinical care and remotely at 12 months +/- 4 weeks postoperatively. Mean change and 95% CI, and effect size of outcome measures will be used to determine the sample size for a future RCT. For the qualitative component, in depth face-to-face semi-structured interviews with physiotherapists and focus groups with participants will be conducted to assess the feasibility, suitability, and acceptability of the prehabilitation intervention using a predetermined success criteria. All qualitative data will be recorded, transcribed verbatim and thematically analysed.DiscussionThis study will be first of its kind to evaluate a systematically developed prehabilitation intervention for patients with FAIS undergoing hip arthroscopy. This study will provide important preliminary data to inform feasibility of a definitive RCT in the future to evaluate effectiveness of a prehabilitation intervention.Trial registrationISRCTN 15371248, 09/03/2023.Trial protocolVersion 2.3, 26th June 2023

PREHAB FAI- Prehabilitation for patients undergoing arthroscopic hip surgery for Femoroacetabular Impingement Syndrome -Protocol for an assessor blinded randomised controlled feasibility study.

Acknowledgements: The authors would like to thank the Physiotherapy Department based at Addenbrooke’s Hospital, Cambridge for their support in delivering the intervention for the study. The authors would also like to thank Physitrack PLC for permitting the use of the images.BACKGROUND: The past decade has seen an exponential growth of minimally invasive surgical procedures. Procedures such as hip arthroscopy have rapidly grown and become the standard of care for patients with Femoroacetabular Impingement Syndrome (FAIS). Although, the results of such procedures are encouraging, a large proportion of patients do not achieve optimal outcomes due to chronicity and deconditioning as a result of delay in diagnosis and increased waiting times amongst other factors. In a recent systematic review and meta-analysis of randomised control trials, moderate certainty evidence supported prehabilitation over standard care in optimising several domains including muscle strength, pain and health related quality of life in patients undergoing orthopaedic surgical interventions. However, the role of prehabilitation in patients with FAI syndrome undergoing hip arthroscopy has received little attention. AIM: To evaluate the feasibility, suitability, acceptability and safety of a prehabilitation programme for FAI to inform a future definitive randomised control trial to assess effectiveness. METHODS: A systematically developed prehabilitation intervention based on a literature review and international consensus will be utilised in this study. A mixed methodology encompassing a two-arm randomised parallel study alongside an embedded qualitative component will be used to answer the study objectives. Patients will be recruited from a tertiary referral NHS centre for young adult hip pathology in the UK. Patient reported outcomes such as iHOT-12, Brief Pain Inventory Scale (Short form), Hospital Anxiety and Depression Scale and Patient Global Impression of Change score will be obtained alongside objective measurements such as Muscle Strength and Star Excursion Balance Test at various time points. Outcome measures will be obtained at baseline (prior to prehabilitation intervention), after prehabilitation before surgery, and at 6 weeks+/- 4 weeks and 6 months +/- 4 weeks (planned primary endpoint for definitive RCT) postoperatively when participants attend the research site for clinical care and remotely at 12 months +/- 4 weeks postoperatively. Mean change and 95% CI, and effect size of outcome measures will be used to determine the sample size for a future RCT. For the qualitative component, in depth face-to-face semi-structured interviews with physiotherapists and focus groups with participants will be conducted to assess the feasibility, suitability, and acceptability of the prehabilitation intervention using a predetermined success criteria. All qualitative data will be recorded, transcribed verbatim and thematically analysed. DISCUSSION: This study will be first of its kind to evaluate a systematically developed prehabilitation intervention for patients with FAIS undergoing hip arthroscopy. This study will provide important preliminary data to inform feasibility of a definitive RCT in the future to evaluate effectiveness of a prehabilitation intervention. TRIAL REGISTRATION: ISRCTN 15371248, 09/03/2023. TRIAL PROTOCOL: Version 2.3, 26th June 2023

PREHAB FAI- Prehabilitation for patients undergoing arthroscopic hip surgery for Femoroacetabular Impingement Syndrome -Protocol for an assessor blinded randomised controlled feasibility study

Background The past decade has seen an exponential growth of minimally invasive surgical procedures. Procedures such as hip arthroscopy have rapidly grown and become the standard of care for patients with Femoroacetabular Impingement Syndrome (FAIS). Although, the results of such procedures are encouraging, a large proportion of patients do not achieve optimal outcomes due to chronicity and deconditioning as a result of delay in diagnosis and increased waiting times amongst other factors. In a recent systematic review and meta-analysis of randomised control trials, moderate certainty evidence supported prehabilitation over standard care in optimising several domains including muscle strength, pain and health related quality of life in patients undergoing orthopaedic surgical interventions. However, the role of prehabilitation in patients with FAI syndrome undergoing hip arthroscopy has received little attention. Aim To evaluate the feasibility, suitability, acceptability and safety of a prehabilitation programme for FAI to inform a future definitive randomised control trial to assess effectiveness. Methods A systematically developed prehabilitation intervention based on a literature review and international consensus will be utilised in this study. A mixed methodology encompassing a two-arm randomised parallel study alongside an embedded qualitative component will be used to answer the study objectives. Patients will be recruited from a tertiary referral NHS centre for young adult hip pathology in the UK. Patient reported outcomes such as iHOT-12, Brief Pain Inventory Scale (Short form), Hospital Anxiety and Depression Scale and Patient Global Impression of Change score will be obtained alongside objective measurements such as Muscle Strength and Star Excursion Balance Test at various time points. Outcome measures will be obtained at baseline (prior to prehabilitation intervention), after prehabilitation before surgery, and at 6 weeks+/- 4 weeks and 6 months +/- 4 weeks (planned primary endpoint for definitive RCT) postoperatively when participants attend the research site for clinical care and remotely at 12 months +/- 4 weeks postoperatively. Mean change and 95% CI, and effect size of outcome measures will be used to determine the sample size for a future RCT. For the qualitative component, in depth face-to-face semi-structured interviews with physiotherapists and focus groups with participants will be conducted to assess the feasibility, suitability, and acceptability of the prehabilitation intervention using a predetermined success criteria. All qualitative data will be recorded, transcribed verbatim and thematically analysed. Discussion This study will be first of its kind to evaluate a systematically developed prehabilitation intervention for patients with FAIS undergoing hip arthroscopy. This study will provide important preliminary data to inform feasibility of a definitive RCT in the future to evaluate effectiveness of a prehabilitation intervention.</p

Chronic Aspergillus fumigatus colonisation of the paediatric cystic fibrosis airway is common and may be associated with a more rapid decline in lung function

Filamentous fungi are commonly isolated from the respiratory tract of CF patients, but their clinical significance is uncertain and the reported incidence variable. We report on the degree of Aspergillus fumigatus airway colonization in a tertiary pediatric CF cohort, evaluate the sensitivity of routine clinical sampling at detecting A. fumigatus, and compare lung function of A. fumigatus-colonized and non-colonized children. We carried out an 8-year retrospective cohort analysis using local databases, examining 1024 respiratory microbiological specimens from 45 children. Nineteen (42%) had a positive A. fumigatus culture at least once during the 8-year period, with 10 (22%) children persistently colonized. Overall, 29% of 48 bronchoalveolar lavage (BAL) samples tested positive for A. fumigatus, compared with 14% of 976 sputum samples. Of 33 children for whom lung function data were available during the study period, seven were classed as having severe lung disease, of whom four (57%) were persistently colonized with A. fumigatus. We conclude that chronic A. fumigatus colonization of the CF airway is common, and may be associated with worse lung function. In our practice, BAL appears superior at detecting lower airway A. fumigatus compared to sputum samples

A randomised crossover trial to compare the potential of stannous fluoride and essential oil mouth rinses to induce tooth and tongue staining

This study compared the staining potential of two experimental amine fluoride/stannous fluoride mouth rinses (A and B), a phenolic/essential oil rinse (C) and a negative control, water, rinse (D). The study was a single centre, randomized, single-blind, four treatment crossover study design among healthy participants. Prior to each study period, participants received a dental prophylaxis. On the Monday of each period, subjects suspended oral hygiene, and under supervision, rinsed with the allocated mouth rinse immediately followed by a warm black tea solution at hourly intervals eight times a day for 4 days. On Friday, the area and intensity of staining on the teeth, the primary outcome measure and dorsum of tongue were assessed. This regimen was repeated for all the three subsequent treatment periods. Rinse B produced less stain than rinse A, but the difference was not significant (p = 0.20). Rinse B produced significantly more stain than rinse C (p < 0.05) and D (p < 0.001). For tongue staining, rinse B produced significantly more staining than D (p < 0.01) but not A or C. Overall, all test rinses produced more staining than placebo with an overall pattern for more staining with stannous formulations. Individuals using stannous or phenolic/essential oil mouth rinse formulations should be advised of the possible staining side effect and that this can be easily removed by a professional dental cleaning

Prehabilitation for Patients Undergoing Orthopedic Surgery

Importance Prehabilitation programs for patients undergoing orthopedic surgery have been gaining popularity in recent years. However, the current literature has produced varying results. Objective To evaluate whether prehabilitation is associated with improved preoperative and postoperative outcomes compared with usual care for patients undergoing orthopedic surgery. Data Sources Bibliographic databases (MEDLINE, CINAHL [Cumulative Index to Nursing and Allied Health Literature], AMED [Allied and Complementary Medicine], Embase, PEDRO [Physiotherapy Evidence Database], and Cochrane Central Register of Controlled Trials) were searched for published trials, and the Institute for Scientific Information Web of Science, System for Information on Grey Literature in Europe, and European clinical trials registry were searched for unpublished trials from January 1, 2000, to June 30, 2022. Study Selection Randomized clinical trials (RCTs) comparing prehabilitation with standard care for any orthopedic surgical procedure were included. Data Extraction and Synthesis Two independent reviewers screened trials. Data were pooled using a random-effects model. Recommendations were determined using the Grading of Recommendations Assessment, Development and Evaluation system and the study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline. Main Outcomes and Measures Pain, function, muscle strength, and health-related quality of life (HRQOL). Results Forty-eight unique trials involving 3570 unique participants (2196 women [61.5%]; mean [SD] age, 64.1 [9.1] years) were analyzed. Preoperatively, moderate-certainty evidence favoring prehabilitation was reported for patients undergoing total knee replacement (TKR) for function (standardized mean difference [SMD], −0.70 [95% CI, −1.08 to −0.32]) and muscle strength and flexion (SMD, 1.00 [95% CI, 0.23-1.77]) and for patients undergoing total hip replacement (THR) for HRQOL on the 36-item Short Form Health Survey (weighted mean difference [WMD], 7.35 [95% CI, 3.15-11.54]) and muscle strength and abduction (SMD, 1.03 [95% CI, 0.03-2.02]). High-certainty evidence was reported for patients undergoing lumbar surgery for back pain (WMD, –8.20 [95% CI, −8.85 to −7.55]) and moderate-certainty evidence for HRQOL (SMD, 0.46 [95% CI, 0.13-0.78]). Postoperatively, moderate-certainty evidence favoring prehabilitation was reported for function at 6 weeks in patients undergoing TKR (SMD, −0.51 [95% CI, −0.85 to −0.17]) and at 6 months in those undergoing lumbar surgery (SMD, −2.35 [95% CI, −3.92 to −0.79]). Other differences in outcomes favoring prehabilitation were of low to very low quality of evidence. Conclusions and Relevance In this systematic review and meta-analysis of RCTs, moderate-certainty evidence supported prehabilitation over usual care in improving preoperative function and strength in TKR and HRQOL and muscle strength in THR, high-certainty evidence in reducing back pain, and moderate-certainty evidence in improving HRQOL in lumbar surgery. Postoperatively, moderate-certainty evidence supported prehabilitation for function following TKR at 6 weeks and lumbar surgery at 6 months. Prehabilitation showed promising results for other outcomes, although high risk of bias and heterogeneity affected overall quality of evidence. Additional RCTs with a low risk of bias investigating preoperative and postoperative outcomes for all orthopedic surgical procedures are required