Practical considerations for conducting dental clinical trials in primary care

Abstract

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 United Kingdom 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.

The effect of dental health education on pregnant women's adherence with toothbrushing and flossing — A randomized control trial

“…The attrition rate in this study, while in line with other similar studies, was high overall (42%) with completion rates in the TAU group lowest at (53%) and the DHE&P group highest at 67%. However, there were no significant differences in demographic characteristics, objective and self‐report of oral hygiene behaviours and social cognitions between women who completed the study and those who did not.…”

Comparing how patients value and respond to information on risk given in three different forms during dental check-ups: the PREFER randomised controlled trial

“…This presented a challenging setting in which to conduct the study and resulted in a retention rate at 6 months of 46%, which is a study limitation. This is not unusual since recruitment rates, retention and compliance with study protocols have been found to be difficult in other general dental practice trials, even in those located in higher socio-economic areas [20, 21]. Relatively poor understanding about research processes, the model of remuneration in dental practices, time pressures and competing priorities (service vs research) make any type of prospective research in dental practices difficult [22].…”

Presenting information on dental risk: PREFER study protocol for a randomised controlled trial involving patients receiving a dental check-up

“…A recent non-randomised study in six NHS dental practices which compared a new model involving a traffic light risk assessment of patients, with other practices using the previous model of dental practice care, found only 291 of 550 participants recruited attended both baseline and follow up appointments (53%). This suggests that long term follow up of patients in a study such as this may present challenges [ 50 ]; and recruitment of dental patients to a trial set in dental practice, especially those with a high/medium risk of oral disease, may present further challenges [ 51 ]. Nevertheless, when considered against the continuum of pragmatic as opposed to explanatory trials, this study is designed to be at the pragmatic end of the spectrum, since its purpose is to examine the intervention (communication of risk information) under the usual conditions in which they will be applied [ 52 ].…”