End of the road for the randomized controlled trial in restorative dentistry?

Satisfactory survival of restorations is central to good practice, not only because unfulfilled patient expectations may lead to adverse medicolegal circumstances, but also because third party funders, managers and governments may also be inquisitive as to the performance of clinicians in their pay. However, there seems to be an obsession among researchers with the Randomized Controlled Clinical Trial (RCCT), and, ok, it is the internationally recognized gold standard. The problem is that the RCCT was designed for medicine and the pharmaceutical industry and not specifically for dentistry, where funding is less and the prescription of a drug or treatment is not so often a matter of life or death, as it may be in medicine, surgery or pharmacy. Another problem is that RCCTs are necessarily expensive, given that these should generally continue for a minimum of five years, with sufficient numbers of patients to satisfy a power calculation.

Manufacturers of dental materials and other funders generally appear reluctant to fund RCCTs into the applied performance of dental materials and restorations. Why? Firstly, as mentioned above, they are expensive and the income from the life of a given dental material is not likely to bring in the profits accrued from a lifetime of (comparatively higher) sales of a successful new drug being marketed in the pharmaceutical industry. Add to that the difficulties and time in recruiting suitable patients, and then placing the restorations, plus the time spent in actually commissioning and organizing the programme.¹ All of this means, according to Cunningham, that it might be well over six years before a 5-year date is ready for analysis.¹