INTERNATIONAL HEALTH RESEARCH TEAM CHALLENGES MANUFACTURERS’ POWER TOOTHBRUSH CLAIMS AND QUALITY OF MEDICAL EVIDENCE

Manchester, UK, January 21, 2003 The Cochrane Oral Health Group today issued a statement criticizing efficacy claims and testing methods of certain power toothbrush manufacturers and challenged dental and medical product companies to develop and adhere to uniform testing standards.

The statement came in response to press releases sent by several power toothbrush manufacturers following a January 11 Oral Health Group report on a comprehensive review of clinical evidence on power toothbrushes.

The Oral Health Group, based at the University of Manchester in England, is one 49 research groups of the Cochrane Collaboration, an international organization with centers in 13 countries. The Collaboration, formed in 1992, is composed of volunteer professionals who use sophisticated analytic techniques to consolidate and assess previously conducted clinical studies. By producing and disseminating systematic reviews of the evidence, Cochrane aims to enabled health professionals, patients, third party agencies and governments to make well-informed choices about healthcare.

In its recent toothbrush review, the Cochrane Oral Health group analyzed all available reports on clinical trials of power toothbrushes conducted between 1964 and 2001. The reviewers found that only one type of power toothbrush action—rotation oscillation, in which the toothbrush head spins first in one direction and then the other—proved more effective than manual toothbrushing. Trials lasting less than one month and products brought to market after 2001 were not included in the Cochrane findings.

• In response to a January 11, 2003 press release in which The Gillette Company set forth positive conclusions about the technology used in particular products, William Shaw, Ph.D, FDS, MScD, the study co-ordinator, said that the Cochrane report states clearly that it endorsed no product. "While certain toothbrushes manufactured by Gillette do use oscillation rotation action, other toothbrushes with such action were also included in the review." Shaw is Professor of Orthodontics at the University of Manchester.

In any case, Shaw said, even "the 7 per cent and 17 per cent reductions of plaque and gingivitis we found for rotation oscillation brushes may be of only modest benefit for dental health." The American Dental Association recommends that only oral care products that can prove a 20 per cent improvement may publish a claim for superiority over products.

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Shaw then criticized the quality of the original clinical trials that provided the basis for the Cochrane review. "Systematic reviews such as those prepared by the Cochrane Collaboration consolidate and assess all relevant research, rather than rely on the selective highlighting of one or two research studies or the experiences of individuals," he said. "However, the usefulness of such reviews, which examine the findings of previously published studies, depends on quality of those published studies. Fundamentally, our report highlights the poor quality of the toothbrush trials upon which every company’s marketing claims are based".

"Companies have not agreed a collective policy on measuring outcome that would enable different studies to be compared, " he added. "It may even be supposed that some researchers had no intention of comparing results."

Yet another problem is that there is no way of telling whether companies have suppressed negative trials that they may have conducted. "This is a situation that will only be resolved when all trials are publicly registered at the outset, just as some forward looking pharmaceutical companies now do. "

"Regrettably," Shaw added, "these same shortcomings affect the majority of research on medical devices, treatments, and medicines." The Cochrane Oral Health Group has more than 100 reviews in the pipeline. The first 29 completed ones cover diverse topics including orthodontic treatment, treatment of decay in primary teeth, fluoride varnish, dental implants, dentine sensitivity, treatment of temporomandibular joint problems, treatment of pre-cancerous conditions, and the oral care of children receiving cancer treatment. "For 27 of these, our reviewers found that the evidence upon which dentist round the world rely to make many important everyday decisions was weak and unreliable."

Shaw said that he welcomed additional observations on the 2003 power toothbrush review, as well as comments and new studies which will be assessed for inclusion when the review is updated in two years. "In the meantime, people who enjoy the feel of a power toothbrush can be assured that it is at least as effective as traditional brushing and that there is no evidence that it will cause more injuries to the gum."

In issuing the statement, Shaw said he hoped to stimulate wider debate on how best to improve the evidence available for dental and medical decision making.

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