New measurements for clinical trials
MIAMI, FL, USA: The principal oral care researcher worldwide for Procter&Gamble, Dr Robert Gerlach, gave a conference at the IADR 87th Session in Miami titled ‘Use of Gingivitis Image Analysis in a Randomized Controlled Trial,’ that proposes a new approach for measuring the efficacy of clinical trials.
“What we tried to do,” said Dr Gerlach, “was to bring objective measurements into clinical trials in oral care, using diagnostics, photography and other technologies, so our research can be conducted without bias, more efficiently, and bring out new products into the marketplace faster to meet the needs of patients.”
Dr Gerlach introduced a new technique to measure gingivitis “which is a very interesting disease for me, because is the one disease that every patient around the world has, has had or will have. The other interesting thing about gingivitis is that it is the oral disease where the symptoms and the clinical signs we see are the same.”
The researcher pointed out that the patient sees bleeding and that the bleeding can be measured for research purposes. He added that gingivitis is also a disease that the patient is aware of.
Dr Gerlach pointed as an example that if you have dental caries early, you never know it until you have cavitation and then you are at the restoration stage, but that gingivitis on the other hand can be treated and reversed.
“We are using simple photography to measure the color of gum tissue,” Dr Gerlach explained, “so this can be done any place in the world with simple equipment. We then extract the color from the photographs so we can measure color in the gingivae overtime because as there is less gingivitis color becomes pinker and tissue firmer, and we can measure color changes and compare it to other therapies.”
Educational tool for the patient
Dr Gerlach said this represents a real advantage compared with other conventional measurement methods. “The other important thing is that we can display the results to the individual or to a group of people, so they can see what will happen if they use dental floss or brush with rotational oscillational tooth brushes or an antimicrobial dental freshener or mouth rinse,” he said. “It allows us a great tool for dental education.”
Asked it patients will be convinced to floss more often or use the latest generation of electric brushes, Dr Gerlach said that patients and professionals like to see the results in people’s mouths.
“What we can do with this new technology is to photograph gingivitis and display it to the patient so hopefully it will increase its acceptability” of proven techniques to reverse it, said the scientist.
Dr Gerlach also cited at the IADR meeting the results of three studies conducted in Latin America by P&G, specifically in Guatemala. “The development of our new technologies is largely based on research conducted in Latin American populations,” he said. Two of the researchers involved in P&G investigations in Latin America are Luis Archila from the University of Texas Health Science Center at San Antonio, TX, USA, and Axel Popol, President of the Guatemala Dental College.