Protocol for a Randomised controlled trial to Evaluate the effectiveness and cost benefit of prescribing high dose FLuoride toothpaste in preventing and treating dEntal Caries in high-risk older adulTs (reflect trial).

BACKGROUND: Dental caries in the expanding elderly, predominantly-dentate population is an emerging public health concern. Elderly individuals with heavily restored dentitions represent a clinical challenge and significant financial burden for healthcare systems, especially when their physical and cognitive abilities are in decline. Prescription of higher concentration fluoride toothpaste to prevent caries in older populations is expanding in the UK, significantly increasing costs for the National Health Services (NHS) but the effectiveness and cost benefit of this intervention are uncertain. The Reflect trial will evaluate the effectiveness and cost benefit of General Dental Practitioner (GDP) prescribing of 5000 ppm fluoride toothpaste and usual care compared to usual care alone in individuals 50 years and over with high-risk of caries. METHODS/DESIGN: A pragmatic, open-label, randomised controlled trial involving adults aged 50 years and above attending NHS dental practices identified by their dentist as having high risk of dental caries. Participants will be randomised to prescription of 5000 ppm fluoride toothpaste (frequency, amount and duration decided by GDP) and usual care only. 1200 participants will be recruited from approximately 60 dental practices in England, Scotland and Northern Ireland and followed up for 3 years. The primary outcome will be the proportion of participants receiving any dental treatment due to caries. Secondary outcomes will include coronal and root caries increments measured by independent, blinded examiners, patient reported quality of life measures, and economic outcomes; NHS and patient perspective costs, willingness to pay, net benefit (analysed over the trial follow-up period and modelled lifetime horizon). A parallel qualitative study will investigate GDPs' practises of and beliefs about prescribing the toothpaste and patients' beliefs and experiences of the toothpaste and perceived impacts on their oral health-related behaviours. DISCUSSION: The Reflect trial will provide valuable information to patients, policy makers and clinicians on the costs and benefits of an expensive, but evidence-deficient caries prevention intervention delivered to older adults in general dental practice. TRIAL REGISTRATION: ISRCTN: 2017-002402-13 registered 02/06/2017, first participant recruited 03/05/2018. Ethics Reference No: 17/NE/0329/233335. Funding Body: Health Technology Assessment funding stream of National Institute for Health Research. Funder number: HTA project 16/23/01. Trial Sponsor: Manchester University NHS Foundation Trust, Oxford Road, Manchester, M13 9WL. The Trial was prospectively registered.

White Mold of Houndstongue (Cynoglossum officinale) Caused by Sclerotinia sclerotiorum in Canada.

Houndstongue (Cynoglossum officinale L.) is a rangeland weed introduced into Canada from Eurasia, and it can be highly toxic to livestock feeding in pastures (3). During 2004, houndstongue plants near Creston, BC, Canada developed water-soaked lesions with white mycelia and black sclerotia on leaves and crowns. Isolations from diseased leaf tissues and sclerotia on potato dextrose agar (PDA) at 20°C for 5 to 7 days produced fungal colonies with formation of black sclerotia 5 to 10 mm in diameter. A single hyphal tip isolate from houndstongue. Ss-HT-C. was compared with a sunflower isolate of S. sclerotiorum, sun-87 (1), for morphology and pathogenicity. For apothecial production, Ss-HT-C and sun-87 were grown on PDA in petri dishes at 10°C for 10 weeks, and sclerotia produced were harvested, placed on moist vermiculite in petri dishes, and incubated at 20°C under light for 3 weeks. Mature apothecia were excised, stained with acid fuchsin, mounted on slides, and examined for asci and ascospores with a microscope. There were no morphological differences between Ss-HT-C and sun-87, each producing an ascus with eight binucleate, elliptical ascospores, measuring 4 × 10 µm (width × length), supporting the identity of Ss-HT-C as S. sclerotiorum (2,4). For pathogenicity tests of Ss-HT-C and sun-87, mycelial plugs (8 mm in diameter) were removed from the margin of colonies grown on PDA for 5 days at 20°C, and placed on leaves of C. officinale plants that were grown in a greenhouse (20 ± 4°C) to the rosette stage. Inoculated plants were covered with clear plastic bags, kept in the same greenhouse for 3 days, and the diameters of the leaf lesions developed at inoculation sites were measured. The experiment was run twice with 30 plants per isolate and five leaves per plant. Uninoculated plants covered with plastic bags were used as controls. Experiments used a completely randomized design. Results of leaf inoculations showed that Ss-HT-C and sun-87 were pathogenic to hound-stongue. There was no statistical difference between isolates or trials. The frequency of leaves with lesions was 90% for Ss-HT-C and 93% for sun-87. The mean leaf lesion diameters were 32 and 35 mm for Ss-HT-C and sun-87, respectively. Leaves of control plants remained healthy. S. sclerotiorum was reisolated from leaves with lesions, but not from controls. After 14 to 21 days, new sclerotia, 5 to 10 mm in diameter, were formed on leaves of inoculated plants. The plants eventually died. This study confirms that S. sclerotiorum is the causal agent for the disease of hound-stongue in Canada, and to our knowledge, this is the first world record of infection of this weed by S. sclerotiorum. References: (1) H. C. Huang and G. C. Kozub. Plant Prot. Bull. 31:333, 1989. (2) L. Kohn, Phytopathology 69:881, 1979. (3) J. A. Pfister et al. J. Range Manag. 45:254, 1992. (4) J. A. L. Wong and H. J. Willetts, J. Gen. Microbiol. 112:29, 1979.

Practical considerations for conducting dental clinical trials in primary care.

There is increasing importance placed on conducting clinical trials in dentistry to provide a robust evidence base for the treatment provided, and models of care delivered. However, providing the evidence upon which to base such decisions is not straightforward, as the conduct of these trials is complex. Currently, only limited information is available about the strategies to deliver successful clinical trials in primary care settings, and even less available on dental clinical trials. Considerable knowledge and experience is lost once a trial is completed as details about effective management of a trial are generally not reported or disseminated to trial managers and researchers. This leads to loss of vital knowledge that could assist with the effective delivery of new trials. The aim of this study is to examine the conduct and delivery of five dental clinical trials across both Australia and the UK and identify the various factors that impacted upon their implementation. Findings suggest that early stakeholder engagement, and well-designed and managed trials, lead to improved outcomes for researchers, clinic staff and patients, and increases the potential for future dissemination and translation of information into practice.