INTERVAL (investigation of NICE technologies for enabling risk-variable-adjusted-length) dental recalls trial: a multicentre randomised controlled trial investigating the best dental recall interval for optimum, cost-effective maintenance of oral health in dentate adults attending dental primary care.

BACKGROUND: Traditionally, patients at low risk and high risk of developing dental disease have been encouraged to attend dental recall appointments at regular intervals of six months between appointments. The lack of evidence for the effect that different recall intervals between dental check-ups have on patient outcomes, provider workload and healthcare costs is causing considerable uncertainty for the profession and patients, despite the publication of the NICE Guideline on dental recall. The need for primary research has been highlighted in the Health Technology Assessment Group's systematic review of routine dental check-ups, which found little evidence to support or refute the practice of encouraging 6-monthly dental check-ups in adults. The more recent Cochrane review on recall interval concluded there was insufficient evidence to draw any conclusions regarding the potential beneficial or harmful effects of altering the recall interval between dental check-ups. There is therefore an urgent need to assess the relative effectiveness and cost-benefit of different dental recall intervals in a robust, sufficiently powered randomised control trial (RCT) in primary dental care. METHODS: This is a four year multi-centre, parallel-group, randomised controlled trial with blinded outcome assessment based in dental primary care in the UK. Practitioners will recruit 2372 dentate adult patients. Patient participants will be randomised to one of three groups: fixed-period six month recall, risk-based recall, or fixed-period twenty-four month recall. Outcome data will be assessed through clinical examination, patient questionnaires and NHS databases. The primary outcomes measure gingival inflammation/bleeding on probing and oral health-related quality of life. DISCUSSION: INTERVAL will provide evidence for the most clinically-effective and cost-beneficial recall interval for maintaining optimum oral health in dentate adults attending general dental practice. TRIAL REGISTRATION: ISRCTN95933794 (Date assigned 20/08/2008).

Improving the Quality of Dentistry (IQuaD): a cluster factorial randomised controlled trial comparing the effectiveness and cost-benefit of oral hygiene advice and/or periodontal instrumentation with routine care for the prevention and management of periodontal disease in dentate adults attending dental primary care.

BACKGROUND: Periodontal disease is preventable but remains the most common oral disease worldwide, with major health and economic implications. Stakeholders lack reliable evidence of the relative clinical effectiveness and cost-effectiveness of different types of oral hygiene advice (OHA) and the optimal frequency of periodontal instrumentation (PI). OBJECTIVES: To test clinical effectiveness and assess the economic value of the following strategies: personalised OHA versus routine OHA, 12-monthly PI (scale and polish) compared with 6-monthly PI, and no PI compared with 6-monthly PI. DESIGN: Multicentre, pragmatic split-plot, randomised open trial with a cluster factorial design and blinded outcome evaluation with 3 years' follow-up and a within-trial cost-benefit analysis. NHS and participant costs were combined with benefits [willingness to pay (WTP)] estimated from a discrete choice experiment (DCE). SETTING: UK dental practices. PARTICIPANTS: Adult dentate NHS patients, regular attenders, with Basic Periodontal Examination (BPE) scores of 0, 1, 2 or 3. INTERVENTION: Practices were randomised to provide routine or personalised OHA. Within each practice, participants were randomised to the following groups: no PI, 12-monthly PI or 6-monthly PI (current practice). MAIN OUTCOME MEASURES: Clinical - gingival inflammation/bleeding on probing at the gingival margin (3 years). Patient - oral hygiene self-efficacy (3 years). Economic - net benefits (mean WTP minus mean costs). RESULTS: A total of 63 dental practices and 1877 participants were recruited. The mean number of teeth and percentage of bleeding sites was 24 and 33%, respectively. Two-thirds of participants had BPE scores of ≤ 2. Under intention-to-treat analysis, there was no evidence of a difference in gingival inflammation/bleeding between the 6-monthly PI group and the no-PI group [difference 0.87%, 95% confidence interval (CI) -1.6% to 3.3%; p = 0.481] or between the 6-monthly PI group and the 12-monthly PI group (difference 0.11%, 95% CI -2.3% to 2.5%; p = 0.929). There was also no evidence of a difference between personalised and routine OHA (difference -2.5%, 95% CI -8.3% to 3.3%; p = 0.393). There was no evidence of a difference in self-efficacy between the 6-monthly PI group and the no-PI group (difference -0.028, 95% CI -0.119 to 0.063; p = 0.543) and no evidence of a clinically important difference between the 6-monthly PI group and the 12-monthly PI group (difference -0.097, 95% CI -0.188 to -0.006; p = 0.037). Compared with standard care, no PI with personalised OHA had the greatest cost savings: NHS perspective -£15 (95% CI -£34 to £4) and participant perspective -£64 (95% CI -£112 to -£16). The DCE shows that the general population value these services greatly. Personalised OHA with 6-monthly PI had the greatest incremental net benefit [£48 (95% CI £22 to £74)]. Sensitivity analyses did not change conclusions. LIMITATIONS: Being a pragmatic trial, we did not deny PIs to the no-PI group; there was clear separation in the mean number of PIs between groups. CONCLUSIONS: There was no additional benefit from scheduling 6-monthly or 12-monthly PIs over not providing this treatment unless desired or recommended, and no difference between OHA delivery for gingival inflammation/bleeding and patient-centred outcomes. However, participants valued, and were willing to pay for, both interventions, with greater financial value placed on PI than on OHA. FUTURE WORK: Assess the clinical effectiveness and cost-effectiveness of providing multifaceted periodontal care packages in primary dental care for those with periodontitis. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56465715. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 38. See the NIHR Journals Library website for further project information.

The effect of introducing a financial incentive to promote application of fluoride varnish in dental practice in Scotland: a natural experiment.

BACKGROUND: Financial incentives are often used to influence professional practice, yet the factors which influence their effectiveness and their behavioural mechanisms are not fully understood. In keeping with clinical guidelines, Childsmile (Scotland's oral health improvement programme) advocates twice yearly fluoride varnish application (FVA) for children in dental practice. To support implementation Childsmile offered dental practitioners a fee-per-item payment for varnishing 2-5-year-olds' teeth through a pilot. In October 2011 payment was extended to all dental practitioners. This paper compares FVA pre- and post-roll-out and explores the financial incentive's behavioural mechanisms. METHODS: A natural experimental approach using a longitudinal cohort of dental practitioners (n = 1090) compared FVA pre- (time 1) and post- (time 2) financial incentive. Responses from practitioners who did not work in a Childsmile pilot practice when considering their 2-5-year-old patients (novel incentive group) were compared with all other responses (continuous incentive group). The Theoretical Domains Framework (TDF) was used to measure change in behavioural mechanisms associated with the incentive. Analysis of covariance was used to investigate FVA rates and associated behavioural mechanisms in the two groups. RESULTS: At time 2, 709 74%, of eligible responders, were followed up. In general, FVA rates increased over time for both groups; however, the novel incentive group experienced a greater increase (ß [95% CI] = 0.82 [0.72 to 0.92]) than the continuous incentive group. Despite this, only 33% of practitioners reported 'always' varnishing increased risk 2-5-year-olds' teeth following introduction of the financial incentive, 19% for standard risk children. Domain scores at time 2 (adjusting for time 1) increased more for the novel incentive group (compared to the continuous incentive group) for five domains: knowledge, social/professional role and identity, beliefs about consequences, social influences and emotion. CONCLUSIONS: In this large, prospective, population-wide study, a financial incentive moderately increased FVA in dental practice. Novel longitudinal use of a validated theoretical framework to understand behavioural mechanisms suggested that financial incentives operate through complex inter-linked belief systems. While financial incentives are useful in narrowing the gap between clinical guidelines and FVA, multiple intervention approaches are required.

Fluoride Varnish for Caries Prevention: Efficacy and Implementation.

Many reviews support fluoride varnish (FV) as a caries-inhibitory agent. Evidence from 6 Cochrane systematic reviews involving 200 trials and more than 80,000 participants further confirms the effectiveness of FV, applied professionally 2-4 times a year, for preventing dental caries in both primary and permanent teeth. The relative benefit of FV application seems to occur irrespective of baseline caries risk, baseline caries severity, background exposure to fluorides, use of fluoride toothpaste and application features such as prior prophylaxis, concentration of fluoride or frequency of application. While the efficacy of FV is acknowledged in clinical practice guidelines globally, the implementation of this recommendation may still be an issue. Factors that may facilitate FV application in the USA include Medicaid eligibility, relationships with dentists/community centers and strong cooperation and communication between physicians and support staff. Barriers include insufficient time to integrate oral health services into well-child visits, difficulty in applying FV (lack of skills/training) and resistance among colleagues and staff. Research in the UK/Scotland also suggests encouraging clinicians in their motivation to perform this treatment and addressing professional and parental concerns relating to possible negative consequences may be influential. Further research targeting cost-effectiveness and how FV in routine care may fit in with political agendas relating to, for example, inequalities in health care provision and access will also play a key part in stakeholder decisions to put resources into this issue.

IQuaD dental trial; improving the quality of dentistry: a multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care.

BACKGROUND: Periodontal disease is the most common oral disease affecting adults, and although it is largely preventable it remains the major cause of poor oral health worldwide. Accumulation of microbial dental plaque is the primary aetiological factor for both periodontal disease and caries. Effective self-care (tooth brushing and interdental aids) for plaque control and removal of risk factors such as calculus, which can only be removed by periodontal instrumentation (PI), are considered necessary to prevent and treat periodontal disease thereby maintaining periodontal health. Despite evidence of an association between sustained, good oral hygiene and a low incidence of periodontal disease and caries in adults there is a lack of strong and reliable evidence to inform clinicians of the relative effectiveness (if any) of different types of Oral Hygiene Advice (OHA). The evidence to inform clinicians of the effectiveness and optimal frequency of PI is also mixed. There is therefore an urgent need to assess the relative effectiveness of OHA and PI in a robust, sufficiently powered randomised controlled trial (RCT) in primary dental care. METHODS/DESIGN: This is a 5 year multi-centre, randomised, open trial with blinded outcome evaluation based in dental primary care in Scotland and the North East of England. Practitioners will recruit 1860 adult patients, with periodontal health, gingivitis or moderate periodontitis (Basic Periodontal Examination Score 0-3). Dental practices will be cluster randomised to provide routine OHA or Personalised OHA. To test the effects of PI each individual patient participant will be randomised to one of three groups: no PI, 6 monthly PI (current practice), or 12 monthly PI.Baseline measures and outcome data (during a three year follow-up) will be assessed through clinical examination, patient questionnaires and NHS databases.The primary outcome measures at 3 year follow up are gingival inflammation/bleeding on probing at the gingival margin; oral hygiene self-efficacy and net benefits. DISCUSSION: IQuaD will provide evidence for the most clinically-effective and cost-effective approach to managing periodontal disease in dentate adults in Primary Care. This will support general dental practitioners and patients in treatment decision making. TRIAL REGISTRATION: Protocol ID: ISRCTN56465715.

E-mail invitations to general practitioners were as effective as postal invitations and were more efficient.

OBJECTIVE: To evaluate which of two invitation methods, e-mail or post, was most effective at recruiting general practitioners (GPs) to an online trial. STUDY DESIGN AND SETTING: Randomized controlled trial. Participants were GPs in Scotland, United Kingdom. RESULTS: Two hundred and seventy GPs were recruited. Using e-mail did not improve recruitment (risk difference=0.7% [95% confidence interval -2.7% to 4.1%]). E-mail was, however, simpler to use and cheaper, costing £3.20 per recruit compared with £15.69 for postal invitations. Reminders increased recruitment by around 4% for each reminder sent for both invitation methods. CONCLUSIONS: In the Scottish context, inviting GPs to take part in an online trial by e-mail does not adversely affect recruitment and is logistically easier and cheaper than using postal invitations.