Behavioural intervention to promote the uptake of planned care in urgent dental care attenders: study protocol for the RETURN randomised controlled trial.

BACKGROUND: People with disadvantaged backgrounds are less likely to visit the dentist for planned care, even though they have disproportionately poorer oral health. They are correspondingly more likely to experience dental problems and use urgent dental care, general practices and Accident and Emergency departments, which not only makes meeting their needs expensive, but, since these services often rely on prescriptions rather than addressing the clinical cause, can contribute to antimicrobial resistance. METHODS: The RETURN intervention has been developed with substantial community co-production, to be delivered opportunistically in urgent dental care settings. This brief intervention is delivered by dental nurses and involves material relevant to the 'in-group' targeted. The material includes booklets relating to barriers to planned dental visiting with corresponding short video clips featuring local people and including a modelling element. Dental nurses are trained to have supportive and non-judgemental conversations, assisting patients to set personal goals and action plans, which are reinforced in a follow-up text within a few weeks. A randomised controlled trial will be undertaken in 3 types of sites: dental practices delivering urgent care (a) within working hours, (b) out of hours, and (c) in a Dental Hospital. The trial will recruit 1180 adult urgent dental care users over 12 months, who have not visited a dentist for a planned care appointment for 2 years or more and do not have a dentist who they visit for routine care. It aims to investigate the effectiveness and cost-effectiveness of the intervention and to explore whether the intervention has different effects across the socio-economic gradient. Participants will be followed up at 6, 12 and 18 months after randomisation. Co-primary outcomes are attendance at a dental practice for planned care within 12 months and self-reported oral health-related quality of life at 12 months. DISCUSSION: This is a pragmatic trial, evaluating the effectiveness of the intervention under the usual condition in which it might be applied. Since dental practices work as independent contractors to the NHS, this brings implementation and fidelity challenges which will be explored and described in embedded qualitative work. TRIAL REGISTRATION: ISRCTN registry identifier ISRCTN84666712. Registered 12/04/2021.

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.

A randomised controlled trial of the use of aciclovir and/or prednisolone for the early treatment of Bell's palsy: the BELLS study.

OBJECTIVE: To determine whether oral prednisolone or aciclovir, used separately or in combination, early in the course of Bell's palsy, improves the chances of recovery at 3 and 9 months. DESIGN: A 2 x 2 factorial randomised double-blind trial. Patients were randomly assigned to treatment by an automated telephone service using a permuted block randomisation technique with block sizes of four or eight, and no stratification. SETTING: Mainland Scotland, with referrals mainly from general practice to 17 hospital trial sites. PARTICIPANTS: Adults (aged 16 years or older) with unilateral facial nerve weakness of no identifiable cause presenting to primary care, the emergency department or NHS24 within 72 hours of symptom onset. INTERVENTIONS: Patients were randomised to receive active preparations or placebo for 10 days: (1) prednisolone (50 mg per day, 2 x 25-mg capsules) and aciclovir (2000 mg per day, 5 x 400-mg capsules); (2) prednisolone and placebo (lactose, indistinguishable); (3) aciclovir and placebo; and (4) placebo and placebo. OUTCOME MEASURES: The primary outcome was recovery of facial function assessed by the House-Brackmann scale. Secondary outcomes included health status, pain, self-perceived appearance and cost-effectiveness. RESULTS: Final outcomes were available for 496 patients, balanced for gender; mean age 44 years; initial facial paralysis moderate to severe. One half of patients initiated treatment within 24 hours of onset of symptoms, one-third within 24-48 hours and the remainder within 48-72 hours. Of the completed patients, 357 had recovered by 3 months and 80 at 9 months, leaving 59 with a residual deficit. There were significant differences in complete recovery at 3 months between the prednisolone comparison groups (83.0% for prednisolone, 63.6% for no prednisolone, a difference of + 19.4%; 95% confidence interval (CI): + 11.7% to + 27.1%, p < 0.001). The number needed to treat (NNT) in order to achieve one additional complete recovery was 6 (95% CI: 4 to 9). There was no significant difference between the aciclovir comparison groups (71.2% for aciclovir and 75.7% for no aciclovir). Nine-month assessments of patients recovered were 94.4% for prednisolone compared with 81.6% for no prednisolone, a difference of + 12.8% (95% CI: + 7.2% to + 18.4%, p < 0.001); the NNT was 8 (95% CI: 6 to 14). Proportions recovered at 9 months were 85.4% for aciclovir and 90.8% for no aciclovir, a difference of -5.3%. There was no significant prednisolone-aciclovir interaction at 3 months or at 9 months. Outcome differences by individual treatment (the four-arm model) showed significant differences. At 3 months the recovery rate was 86.3% in the prednisolone treatment group, 79.7% in the aciclovir-prednisolone group, 64.7% in the placebo group and 62.5% in the aciclovir group. At 9 months the recovery rates were respectively 96.1%, 92.7%, 85.3% and 78.1%. The increase in recovery rate conferred by the addition of prednisolone (both for prednisolone over placebo and for aciclovir-prednisolone over aciclovir) is highly statistically significant (p < 0.001). There were no significant differences in secondary measures apart from Health Utilities Index Mark 3 (HUI3) at 9 months in those treated with prednisolone. CONCLUSIONS: This study provided robust evidence to support the early use of oral prednisolone in Bell's palsy as an effective treatment which may be considered cost-effective. Treatment with aciclovir, either alone or with steroids, had no effect on outcome.

Changing clinicians' behavior: a randomized controlled trial of fees and education.

The fissure-sealing of newly erupted molars is an effective caries prevention treatment, but remains underutilized. Two plausible reasons are the financial disincentive produced by the dental remuneration system, and dentists' lack of awareness of evidence-based practice. The primary hypothesis was that implementation strategies based on remuneration or training in evidence-based healthcare would produce a higher proportion of children receiving sealed second permanent molars than standard care. The four study arms were: fee per sealant treatment, education in evidence-based practice, fee plus education, and control. A cost-effectiveness analysis was conducted. Analysis was based on 133 dentists and 2833 children. After adjustment for baseline differences, the primary outcome was 9.8% higher when a fee was offered. The education intervention had no statistically significant effect. 'Fee only' was the most cost-effective intervention. The study contributes to the incentives in health care provision debate, and led to the introduction of a direct fee for this treatment.

Routine scale and polish for periodontal health in adults.

BACKGROUND: Many dentists or hygienists provide scaling and polishing for patients at regular intervals, even if those patients are considered to be at low risk of developing periodontal disease. There is debate over the clinical effectiveness and cost effectiveness of 'routine scaling and polishing' and the 'optimal' frequency at which it should be provided. OBJECTIVES: The main objectives were: to determine the beneficial and harmful effects of routine scaling and polishing for periodontal health; to determine the beneficial and harmful effects of providing routine scaling and polishing at different time intervals on periodontal health; to compare the effects of routine scaling and polishing provided by a dentist or professionals complementary to dentistry (PCD) (dental therapists or dental hygienists) on periodontal health. SEARCH STRATEGY: We searched the Cochrane Oral Health Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE. Reference lists from relevant articles were scanned and the authors of eligible studies were contacted where possible to identify trials and obtain additional information. Date of most recent searches: 5th March 2007. SELECTION CRITERIA: Trials were selected if they met the following criteria: design - random allocation of participants; participants - anyone with an erupted permanent dentition who were judged to have received a 'routine scale and polish' (as defined in this review); interventions - 'routine scale and polish' (as defined in this review) and routine scale and polish provided at different time intervals; outcomes - tooth loss, plaque, calculus, gingivitis, bleeding and periodontal indices, changes in probing depth, attachment change, patient-centred outcomes and economic outcomes. DATA COLLECTION AND ANALYSIS: Information regarding methods, participants, interventions, outcome measures and results were independently extracted, in duplicate, by two review authors. Authors were contacted where possible and where deemed necessary for further details regarding study design and for data clarification. A quality assessment of all included trials was carried out. The Cochrane Collaboration's statistical guidelines were followed and both standardised mean differences and mean differences were calculated as appropriate using random-effects models. MAIN RESULTS: Nine studies were included in this review. All studies were assessed as having a high risk of bias.Two split-mouth studies provided data for the comparison between scale and polish versus no scale and polish. One study, involving patients attending a recall programme following periodontal treatment, found no statistically significant differences for plaque, gingivitis and attachment loss between experimental and control units at each time point during the 1 year trial. The other study, involving adolescents in a developing country with high existing levels of calculus who had not received any dental treatment for at least 5 years, reported statistically significant differences in calculus and gingivitis (bleeding) scores between treatment and control units at 6, 12 and 22 months (in favour of 'scale and polish units') following a single scale and polish provided at baseline to treatment units. For comparisons between routine scale and polish provided at different time intervals, there were some statistically significant differences in favour of scaling and polishing provided at more frequent intervals: 2 weeks versus 6 months, 2 weeks versus 12 months (for the outcomes plaque, gingivitis, pocket depth and attachment change); 3 months versus 12 months (for the outcomes plaque, calculus and gingivitis). There were no studies comparing the effects of scaling and polishing provided by dentists or professionals complementary to dentistry. AUTHORS' CONCLUSIONS: The research evidence is of insufficient quality to reach any conclusions regarding the beneficial and adverse effects of routine scaling and polishing for periodontal health and regarding the effects of providing this intervention at different time intervals. High quality clinical trials are required to address the basic questions posed in this review.

Routine scale and polish for periodontal health in adults.

BACKGROUND: Many dentists or hygienists provide scaling and polishing for patients at regular intervals, even if those patients are considered to be at low risk of developing periodontal disease. There is debate over the clinical effectiveness and cost effectiveness of 'routine scaling and polishing' and the 'optimal' frequency at which it should be provided. OBJECTIVES: The main objectives were: to determine the beneficial and harmful effects of routine scaling and polishing for periodontal health; to determine the beneficial and harmful effects of providing routine scaling and polishing at different time intervals on periodontal health; to compare the effects of routine scaling and polishing provided by a dentist or professionals complementary to dentistry (PCD) (dental therapist or dental hygienist) on periodontal health. SEARCH STRATEGY: We searched the Cochrane Oral Health Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE. Reference lists from relevant articles were scanned and the authors of eligible studies were contacted where possible to identify trials and obtain additional information. Date of most recent searches: 9th April 2003. SELECTION CRITERIA: Trials were selected if they met the following criteria: design - random allocation of participants; participants - anyone with an erupted permanent dentition who were judged to have received a 'routine scale and polish' (as defined in this review); interventions - 'routine scale and polish' (as defined in this review) and routine scale and polish provided at different time intervals ; outcomes- tooth loss, plaque, calculus, gingivitis, bleeding and periodontal indices, changes in probing depth, attachment change, patient-centred outcomes and economic outcomes. DATA COLLECTION AND ANALYSIS: Information regarding methods, participants, interventions, outcome measures and results were independently extracted, in duplicate, by two reviewers. Authors were contacted where possible and where deemed necessary for further details regarding study design and for data clarification. A quality assessment of all included trials was carried out. The Cochrane Collaboration's statistical guidelines were followed and both standardised mean differences and weighted mean differences were calculated as appropriate using random-effects models. MAIN RESULTS: Eight studies were included in this review and all studies were assessed as having a high risk of bias. Two split-mouth studies provided data for the comparison between scale and polish versus no scale and polish. One study, involving patients attending a recall programme following periodontal treatment, found no statistically significant differences for plaque, gingivitis and attachment loss between experimental and control units at each time point during the 1 year trial. The other study, involving adolescents in a developing country with high existing levels of calculus who had not received any dental treatment for at least 5 years, reported statistically significant differences in calculus and gingivitis (bleeding) scores between treatment and control units at 6, 12 and 22 months (in favour of 'scale and polish units') following a single scale and polish provided at baseline to treatment units. For comparisons between routine scale and polish provided at different time intervals, there were some statistically significant differences in favour of scaling and polishing provided at more frequent intervals: 2 weeks versus 6 months, 2 weeks versus 12 months (for the outcomes plaque, gingivitis, pocket depth and attachment change); 3 months versus 12 months (for the outcomes plaque, calculus and gingivitis). There were no studies comparing the effects of scaling and polishing provided by dentists or Professionals Complementary to Dentistry. AUTHORS' CONCLUSIONS: The research evidence is of insufficient quality to reach any conclusions regarding the beneficial and adverse effects of routine scaling and polishing for periodontal health and regarding the effects of providing this intervention at different time intervals. High quality clinical trials are required to address the basic questions posed in this review.

Effectiveness of strategies to disseminate and implement clinical guidelines for the management of impacted and unerupted third molars in primary dental care, a cluster randomised controlled trial.

OBJECTIVE: To investigate the effectiveness and cost-effectiveness of different guideline implementation strategies, using the Scottish Intercollegiate Guidelines Network (SIGN) Guideline 42 "Management of unerupted and impacted third molar teeth" (published 2000) as a model. DESIGN: A pragmatic, cluster RCT (2x2 factorial design). SUBJECTS: Sixty-three dental practices across Scotland. Clinical records of all 16-24-year-old patients over two, four-month periods in 1999 (pre-intervention) and 2000 (post-intervention) were searched by a clinical researcher blind to the intervention group. Data were also gathered on the costs of the interventions. INTERVENTIONS: Group 1 received a copy of SIGN 42 Guideline and had an opportunity to attend a postgraduate education course (PGEC). In addition to this, group 2 received audit and feedback (A and F). Group 3 received a computer aided learning (CAL) package. Group 4 received A and F and CAL. PRINCIPAL OUTCOME MEASUREMENT: The proportion of patients whose treatment complied with the guideline. RESULTS: The weighted t-test for A and F versus no A and F (P=0.62) and CAL versus no CAL (P=0.76) were not statistically significant. Given the effectiveness results (no difference) the cost effectiveness calculation became a cost-minimisation calculation. The minimum cost intervention in the trial consisted of providing general dental practitioners (GDPs) with guidelines and the option of attending PGEC courses. Routine data which subsequently became available showed a Scotland-wide fall in extractions prior to data collection. CONCLUSION: In an environment in which pre-intervention compliance was unexpectedly high, neither CAL nor A and F increased the dentists' compliance with the SIGN guideline compared with mailing of the guideline and the opportunity to attend a postgraduate course. The cost of the CAL arm of the trial was greater than the A and F arm. Further work is required to understand dental professionals' behaviour in response to guideline implementation strategies.

Scottish consortium for development and education in dental primary care.

A national consortium for dental primary care in Scotland has been formed as a result of integrated planning by groups involved in managing and delivering postgraduate dental education in Scotland. In 1998 a partnership was formed with representatives from the Scottish Council for Postgraduate Medical and Dental Education (SCPMDE) and the three Scottish dental institutions at Dundee, Edinburgh and Glasgow Universities. The principal aim of the Consortium is to promote evidence-based dental care through postgraduate education and research. The activities of the Consortium will provide a broadly based adjunct to current postgraduate provision with partner institutions contributing in different ways. Since its inception the Consortium has focused on two main areas: 'Higher Training' for Primary Care. Scottish Dental Practice Based Research Network.

Cost: benefit of prevention in practice.

An enquiry among 50 successful, general dental practitioners working under a capitation payment system for the treatment of children, showed that they all thought that prevention on selected patients was of value to their practice. They said that prevention enhances the reputation of the practice, adds to the job satisfaction of the dentist and is part of modern dental philosophy. However, only when practised selectively would it be cost: beneficial. The most popular preventive treatments were fissure sealants, particularly when used on selected patients, oral hygiene demonstrations and, among a group of enthusiastic dentists, dietary counselling. Dentists who employed hygienists had a significantly higher 'mean preventive awareness score' than those who did not.

Mothers' perceptions of access to medical care for children in Otago.

Three hundred urban and 350 rural mothers were surveyed about their subjective perceptions of the availability of a doctor for their child. A third of rural mothers and a quarter of urban mothers expressed concern about lack of access. Shared parenting, a high socioeconomic status of mother and her partner and further training on leaving school, were associated with a greater satisfaction with existing services. Mothers with chronic psychiatric morbidity were more likely to express concern. Approximately one quarter of mothers expressed satisfaction with services overall. Specific improvements for child health services included reduced costs and waiting times together with an increase in the range of services available.