Dr.Collins BioMin Restore Plus: the first ever fluoride-containing bioglass toothpaste to get FDA approval
Dr.Collins is delighted to announce that its BioMin Restore Plus Toothpaste has received FDA 510K approval for relief of sensitivity. This is a huge breakthrough, being the first fluoride-containing bioactive glass toothpaste to be approved by the FDA for sale in the United States *(see footnote).
The toothpaste uniquely controls the release of calcium, phosphate and fluoride ions for many hours after brushing to develop acid resistant fluorapatite on the tooth surface and inside exposed dentine tubules.
Available only on prescription from registered dental clinicians, Dr.Collins BioMin Restore Plus is based on BioMin® F, a patented bioactive glass complex developed in the laboratories of Queen Mary University of London, UK, by Professor Robert Hill and his team of material scientists. This award-winning formulation was introduced in Europe in late 2016, and is now available in many regions around the world. Dr.Collins Inc, California, the US license holder, anticipate the product will be available in the US spring 2021.
After brushing with Dr.Collins BioMin Restore Plus, the active ingredient adheres to the tooth surface, where these microscopic particles slowly dissolve over an 8-12 hour period, constantly releasing calcium, phosphate and fluoride ions. These combine to deposit fluorapatite, similar to natural tooth enamel but more acid resistant, forming a protective coating on the tooth surfaces. It is also precipitated inside any exposed dentine tubules, plugging them and preventing the fluid flow which causes dentine hypersensitivity.
This controlled release mechanism, continuing to deposit mineral on the tooth surface over several hours, helps Dr.Collins BioMin Restore Plus to be more effective at relieving sensitivity than conventional toothpastes, which are rinsed away in around an hour. Studies at Queen Mary University have shown that new mineral is created in less than an hour after brushing and the process can continue for up to 12 hours.
BioMin’s Clinical Consultant, Dr David Gillam believes: “There are many causes of dentine hypersensitivity which means that previously no single toothpaste worked for everyone. One of the advantages of BioMin is that it provides a constant supply of low levels of fluoride, calcium and phosphate in the biofilm/saliva/dental interface, which allows fluorapatite to be deposited gradually.”
Studies around the world also confirm that the fluorapatite developed from BioMin F penetrates deeply inside exposed dentine tubules. In a recent poll undertaken by BioMin, dental clinicians reported that dentine hypersensitivity affects well over 40% of the population and most prevalently between the ages of 20-50. It can range from mild irritation to severe discomfort, affecting quality of life. Response to hot and cold are the most common symptoms, and nearly half the dental clinicians taking part in the poll felt unsatisfied with their treatment of such cases.
Californian dental hygienist and dental health educator, Theresa McCarter, has been recommending BioMin toothpastes for some time and reports that it has changed the lives of many most severely affected patients. She commented: “I am delighted to see that the fluoride version of BioMin toothpaste is finally becoming available for US clinicians to prescribe for their patients. I feel it is an excellent everyday toothpaste which will benefit 80-90% of my patients. I am sure this product will become a real gamechanger.”
Dr Colin Suzman, a California dentist and founder of Dr.Collins, Inc, had this to say: “ We are delighted that the FDA has given us the approval to provide BioMin Restore Plus toothpaste to the American public via the dental profession. It is a real achievement for a start-up organisation to achieve this result. We believe this ground-breaking technology will bring considerable benefit to many sufferers of dentine hypersensitivity. We are now proceeding to full production and hope to have the product available by end of Q1 2021.”
Dr.Collins BioMin Restore Plus toothpaste has a fresh mint taste and leaves the mouth feeling clean and healthy. For those who prefer a fluoride-free alternative, Dr Collins BioMin Restore toothpaste is also available, based on a calcium/phosphate bioglass.
Since its launch in 2008, the Dr.Collins® brand has been at the leading edge of oral care technology. Its innovative products – toothpastes, Perio Toothbrush® and Perio CleanPic® – are distributed through a variety of channels, including retail stores, online outlets and professional dental offices. Dr.Collins BioMin Restore and Restore Plus toothpastes are directly available at https://biomintoothpaste.com.