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

Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial

Background Results of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects. Methods FOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762. Findings Between Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839–1·079]; p=0·439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26–6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38–2·43]; p=0·0070). There were no significant differences in any other event at 6 or 12 months. Interpretation Fluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function. Funding UK Stroke Association and NIHR Health Technology Assessment Programme

A pilot study to evaluate the impact of digital imaging on the delivery of oral hygiene instruction

Aims To determine whether personalised Oral Hygiene Advice (OHA) using an intra-oral-camera (IOC) combined with standard OHA as provided in general dental practice reduces plaque levels after 4 weeks more than the provision of standard OHA. Materials and Methods 22 healthy adult participants diagnosed with gingivitis took part in this pilot parallel-designed, randomised, examiner-blind, 2x-treatment, study regarding their home-care oral hygiene habits and attitudes to oral health. An IOC-image was taken and plaque, gingival and bleeding scores were recorded. Test group participants received standard OHA with IOC-images to indicate areas for improvement, control group participants received standard OHA. Questionnaires and plaque, gingival and bleeding scores were repeated after 4 weeks. Plaque was scored from the IOC-images and scores compared to clinical plaque scores. Results Lifestyle habits, attitudes to oral health, plaque (0.63vs0.61, control vs test) and bleeding scores (1.17vs0.96, control vs test) were similar at baseline. After 4-weeks, plaque scores improved more in test as compared to control group (39.4vs20.6%, p<0.05, while gingival and bleeding scores approached significance. There was no difference in lifestyle habits between groups, but the test group reported significantly greater confidence in adhering to their bespoke oral health plan. Agreement between the clinical and IOC plaque scores was good. Conclusions Use of IOC further personalises the prevailing standard of oral hygiene advice and generates great patient engagement with pictorial reports to facilitate a more in-depth patient explanation of their gingival health, resulting in significant plaque reduction and improved gingival health compared to the standard OHA alone