Title: Can H-Ts maintain the oral health of routine low-risk dental recall patients in "high-street" dental practices: a pilot study
Funder: Department of Health and Social Care

Abstract: The use of General Dental Practitioners (GDPs) as the "front-line" clinician in NHS “high-street” dental practices is costly. Over half of the 21.7 million Routine Dental Examinations (RDEs) undertaken each year result in no further treatment. Hygiene-Therapists (H-Ts) have been shown to be equally efficacious at screening for oral diseases (Brocklehurst et al., 2015; Macey et al., 2015). What is not known is whether they are as effective as GDPs at undertaking the RDE for “low risk” routine NHS dental patients and whether they could reduce the cost of service provision. This is important as the proportion of “low risk” routine NHS dental patients is expected to increase further as the oral health of regular dental attenders continues to improve. In contrast, almost half of the population do not regularly attend the dentist and this group has the highest need. Current NHS regulations do not allow H-Ts to undertake examinations on NHS patients. However, in 2013/14, regulatory changes made by the General Dental Council allowed H-Ts to see patients directly, diagnose and form treatment plans. H-Ts can also now undertake all of the direct routine treatments that GDPs can do (e.g. fillings) as part of their Scope of Practice. This opens up the possibility of them being able to be used to examine and treat "low-risk" NHS patients in the future, if they can be shown to be as equally effective as GDPs. Two earlier NIHR grants have investigated both the efficacy and efficiency of using H-Ts in NHS practices (NIHR/CS/010/004 & HS&DR 11/1025/04) (lead applicant PRB was PI on both studies). The former demonstrated their efficacy (their diagnostic test accuracy) and feasibility of using H-Ts for RDEs and the latter found that dental practices using H-Ts in the NHS could be better organised to improve efficiency (Macey et al., 2016; Brocklehurst et al., 2016). A pilot study is the next step to inform the design of a definitive trial. This will test whether H-Ts are as good at maintaining the oral health of "low-risk" routine NHS dental patients (but are a cheaper option) i.e. a non-inferiority design. It will also test cross-overs from the intervention arm to the treatment as usual arm (RDE and treatment by the GDP). An individually randomised pilot study in the North-West of England with a 15 month follow-up period is proposed: • Population: adult asymptomatic "low-risk” routine dentate or partially dentate NHS patients; • Intervention: RDE and any subsequent treatment by a H-T; • Control: RDE and subsequent treatment by a GDP (“current practice”); • Outcome: proportion of sites that bleed on probing. Recruited and consented “low risk” NHS dental patients will have baseline and outcome measurements undertaken by calibrated and blinded epidemiologists. “Low risk” is defined as those patients who have not presented with any active dental decay or required any dental fillings due to dental caries within the previous two years. Secondary outcome measures will include quality of life, proportion of sites that have visible plaque present, unplanned visits between RDEs and other routinely collected indices. A health economic analysis and its data collection tool will be piloted and a process evaluation using a realist framework will aim to understand “what works, for whom, why and in what circumstances”, including the intervention's social acceptability (Pawson, 2013).

Lay abstract: Over one half of all “dental check-ups” result in no further treatment. The patient is examined by a dentist and returned to the recall list for a further “check-up” in another six or twelve months’ time. As the oral health of regular dental attenders improves further, it is likely that more and more patients will be "low-risk" and will only require a simple “check-up” in the future, with no further treatment. As a result, the use of the dentist to undertake the routine dental “check-up” is becoming quite a costly way of providing care for those patients who are at a "low risk" of future disease. Research undertaken by the same team has shown that other less expensive members of the dental team, known as Hygiene-Therapists, are just as good at detecting dental decay, gum disease and oral cancer. Using Hygiene-Therapists to undertake "check-ups" on low risk patients could help free up the dentists’ time to concentrate on more complex cases. It could also be a way of freeing up resources in the practice to treat patients who currently don’t access care. This could help meet some of the future challenges for NHS dentistry, like the growing number of house-bound elderly. Also, half of the population do not visit a dentist regularly and this group of people have the most dental disease. Freeing up dentists time and using Hygiene-Therapists to see regular "low-risk" dental attenders could help release resources to address some of these issues. The current NHS regulations that were introduced in 2005 do not allow Hygiene-Therapists to undertake examinations on NHS patients. However, in 2013, the body responsible for regulating the dental profession and for protecting patient safety (General Dental Council) reviewed all the scientific evidence and ruled that Hygiene-Therapists could see patients directly, undertake an examination and do routine dental treatment (e.g. fillings). These changes provide an opportunity to test whether Hygiene-Therapists could undertake the “check-up” and manage "low-risk" regular dental patients in the NHS. The use of Hygiene-Therapists also has the potential to improve the level of prevention offered to regularly attending patients, as their training is based heavily on a preventive philosophy. To explore this, a pilot study is proposed over a fifteen month period. This will inform the design of a definitive trial. The current practice of using dentists to provide “check-ups” will form the control arm and will be compared to the new model, where dental “check-ups” and any subsequent treatment will be provided by Hygiene-Therapists. At the end of the study, differences in oral health will be assessed, using accepted measures of "gum" disease, oral cleanliness and tooth decay. At the same time as the trial, parallel interviews will explore dentists’, Hygiene-Therapists’ and patients’ views to improve our understanding about what could work well, how and under which conditions. The study will also look at the potential cost savings of using Hygiene-Therapists. The research has the full support of Health Education England, which is the national body that plans the clinical workforce and will address important policy issues for the NHS moving forward. If the use of Hygiene-Therapists is shown to be as effective as dentists in this role, the research could have a large impact on how NHS dental services are designed in the future.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: ORAL AND GASTROINTESTINAL