Earlier this year, the Cochrane Collabroation independently reviewed the safety and effectiveness of triclosan-containing toothpastes. The collaboration's positive findings were of great significance for Colgate, which utilizes a triclosan/copolymer active ingredient in its line of Colgate Total toothpastes.
Just how significant were the findings? To find out, DentistryIQ interviewed Colgate's Global Director of Scientific Affairs, Dr. Fotinos Panagakos. In this video interview, Panagakos explains why the Cochrane Review may change the minds of dental professionals and public health advocates who have been hesitant to recommend triclosan-based oral hygienes.
An abbreviated transcript of the video may be found below. For video play on iOS devices (iPhone, iPad, etc.), click here.
To go to the full Cochrane Review, click here.
DentistryIQ: Dr. Panagakos, there have been many studies evaluating the triclosan/copolymner antibacterial active system. What makes the Cochrane Review significant?
Dr. Fotinos Panagakos: This news is significant because the Cochrane Group is an unaffiliated third party organization that is internationally recognized as the highest standard in clinical research. So getting this affirmation takes the science behind Colgate Total to an entirely new level.
Even though Colgate Total is the most extensively reviewed toothpaste in the world, dental professionals, key opinion leaders and media are sometimes skeptical of studies paid for by oral care manufacturers. The findings from the Cochrane Collaboration’s independent review of the research reaffirms previous systematic reviews which found that Colgate Total is the only toothpaste that is FDA-approved via a new drug application which is clinically proven to reduce plaque and gingivitis.
DIQ: Before we get to the specific findings of the review, could you tell us more about how the triclosan copolymer system works in reducing the bacterial load in the oral cavity?
FP: Colgate Total contains triclosan, a very potent anti-bacterial and anti-inflammatory ingredient, in combination with a copolymer, polyvinyl methyl ether and maleic acid. The system delivers triclosan while brushing to the teeth and soft tissues of the mouth. The copolymer traps the triclosan as it adheres to the hard and soft tissues, slowly releasing the triclosan over a 12-hour period post-brushing. Studies have shown that this 12-hour protection reduces the level of plaque that develops around the teeth, and also reduces the levels of bacteria on the other soft tissues of the mouth, which can often serve as a reservoir for recolonization of the plaque biofilm. When used twice daily on a regular basis, Colgate Total can reduce plaque biofilm, gingival inflammation, calculus and malodor. It has also been shown to be a very effective toothpaste for patients who have been treated for periodontitis, reducing the recolonization of the biofilm and retarding the progression of the periodontal disease.
DIQ: The Cochrane Review found that when compared with fluoride-only toothpastes, the triclosan/copolymer plus fluoride system resulted in the following
- 22% reduction in plaque
- 22% reduction of gingivitis
- 48% reduction in bleeding gums
- 5% reduction in tooth decay
When we think about the state of oral health in America and around the world, what is the significance of these numbers, both in terms of oral health and the oral-systemic connection?
FP: Recently, a report based on the latest NHANES epidemiological data suggests that almost one out of every two Americans have periodontal disease. This is much higher than previously estimated levels. Additionally, only Colgate Total provides both antibacterial and anti-inflammatory benefits. With the growing body of science linking oral health to overall health, this is an important distinction.
DIQ: There are some groups who believe there is not enough information to confirm the safety of the triclosan/copolymer system. To what degree does the Cochrane Review challenge this argument?
FP: The Cochrane Review authors examined the studies included in the report for any adverse events that were reported during the studies. They found that the studies that did include this information did not report any adverse events that could be attributed to the use of Colgate Total in the study. There is ample scientific evidence supporting the safety and efficacy of Colgate Total – more than 80 scientific studies published in peer-reviewed journals and involving 19,000 people. Colgate’s own research spans 20 years and includes clinical studies completed as recently as 2012. Our research is shared with regulatory agencies in Europe, the United States, Australia and Canada. All have conducted their own independent reviews of triclosan, and in every case, they have affirmed the safety of triclosan in toothpaste.
In the US, the FDA required Colgate to submit a New Drug Application (NDA). This is the same process the FDA uses to approve prescription medications. The FDA’s NDA approval requires ongoing safety vigilance. Since 1997, safety has been continuously monitored by a global pharmaco-vigilance system for adverse events, and we provide annual safety updates. FDA Deputy Director Dr. Sandy Kweder in December reiterated the agency’s support for the safety and efficacy of Colgate Total toothpaste.
DIQ: The Cochrane Review distinguished between findings based on “moderate-quality evidence” and “high-quality evidence.” Were any of these distinctions important in your view, or possibly create a belief that stronger testing is needed in some areas?
FP: One of the strengths of the Cochrane Review process is the assessment of the evidence from a quality perspective. A number of factors go into determining this level for each study evaluated. These distinctions are important. And, as with any research, more is always better. This is why Colgate has continued to study the effects of Colgate Total on a wide variety of oral diseases. Recently, studies demonstrated Colgate Total can reduce the levels of oral bacteria on soft tissue surfaces in the mouth, and that Colgate Total as effective in reversing early gingival inflammation around dental implants.
DIQ: In February, Colgate held a press conference at the Chicago Dental Society Midwinter Meeting to alert the dental world to the Cochrane findings. What has the response been from the dental and greater health-care community?
FP: We’ve actually received an abundant amount of positive feedback and support from the dental community, particularly from members of the media, and both dental and hygiene key thought leaders throughout the industry. The findings were no surprise to anyone who really knows this field, but it's been very beneficial to have this information confirmed by the high-profile Cochrane Collaboration. A lot of dental professionals were already aware of the benefits of triclosan, but now that we are able to present clinical findings from such a prestigious review, the industry seems to rest assured that this information is not clouded in any way; free of any other intentions other than facts based on scientific research. I think they are more confident in reporting this data knowing that it is not based on marketing or “manufacturer claims.”
DIQ: As a final thought, is there anything you’d like dental professionals and the general public to know about Colgate’s commitment to the safety and effectiveness of its products?
FP: By delivering clinically proven protection against gum disease, Colgate Total provides an important and needed oral and public health benefit. Its safety and effectiveness is supported by more than 80 scientific studies. Colgate recognizes the importance of continuous scientific study and therefore conducts research, publishes papers and actively participates in expert symposia on an ongoing basis, closely investigating all new information. We remain confident that ongoing independent reviews will continue to add to the substantial body of research affirming the safety and effectiveness of triclosan in Colgate Total.
###
