Evidence forms the data set that a manufacturer develops for each product to achieve a successful launch. An evidence-based decision-making process has become the logical way in which to gather the required data. Using the example of the history of power toothbrush development, this article outlines the steps that occur from laboratory testing to randomized controlled clinical trials. The rationale behind each step is discussed together with advantages and disadvantages. ‘‘The deepest sin against the human mind is to believe things without evidence.’’ 1 In the area of product development it is evidence that the research scientist is seeking to prove or disprove a hypothesis. Evidence drives the development phase in determining the final product, and without adequate evidence of safety and performance, a product cannot be launched. In fact, evidence forms the data set that a manufacturer develops for each product to achieve a successful launch. Evidence-based decision making is now recognized as a logical way to formulate questions and then find and appraise the answers. 2 This holds true in industry for product development, just as it does in a medical or dental practice to assess treatments. A century ago medicinal products, drugs, and devices were launched to the uneducated public with minimal evidence. Snake oil and quick fix remedies were the order of the day, and the stronger the claim being made and the more mystery surrounding the product, the greater the perception of efficacy. The area of oral hygiene was no exception; Dr. Scott’s toothbrush, ‘‘permanently charged with an electromagnetic current,’’ claimed in 1880 to offer advantages in tooth cleaning. 3 A mechanical or electrical remedy to improve tooth cleaning has continued as a goal for over a century. The first published evidence for a device that cleaned teeth by mechanical means was in the form of a patent from a Swedish watchmaker by the name of Frederick Tornberg. 4 His 1885 patent clearly described the mechanics and function of the device, but there is no report as to whether this product was ever produced. Simple clockwork or hand-turned devices did exist, but there is no published data recounting their efficacy or safety. The first electric toothbrush was introduced in 1939, but it was not until the middle of the twentieth century that mechanical, electrically powered toothbrushes first became readily available. Initially, these brushes obtained their power source directly from the mains. With the mass production of batteries, both replaceable and rechargeable versions became available. Development of these devices was based on the theory that these mechanical devices should mimic the action of a properly used manual toothbrush and, as such, there was little data to support their performance. State-of-the-art reviews from 1966 to 1986, 5 failed to discover any published evidence to support an efficacy claim of superiority for powered toothbrushes over manual toothbrushes. The world workshop of Periodontology in 1966 concluded, ‘‘Powered and manual tooth brushes can be used with equal effectiveness for removing and preventing the formation of dental plaque.’’ This view was repeated 10 years later at the subsequent 1977 World Workshop in Chicago: ‘‘Studies carried out since Ann Arbor gave no reason for amending the previous conclusions,’’ citing no change in toothbrush design, quality, or performance since the previous review. By 1996 there were a number of power toothbrush designs on the world market, but published scientific evidence was still sparse and the Hancock review of prevention for that World Workshop concluded the designs were satisfactory but should receive more rigorous testing. 6
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Mar 29, 2005
Stefan Zimmer + 5
Open Access