First ever fluoride-containing bioglass toothpaste wins FDA approval
British-developed BioMin F, known in the US as Dr.Collins BioMin Restore Plus, is to be available in the USA.
Dr.Collins has announced that its BioMin Restore Plus Toothpaste has received FDA 510K approval for relief of sensitivity.
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, the patented bioactive glass complex developed in the laboratories of Queen Mary University of London, UK, by Professor Robert Hill and his team of materials 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, anticipates the product will be available in the US in spring 2021.
"This is a huge breakthrough and a fantastic achievement for a start-up organisation to achieve this result," said Colin Suzman, founder of Dr.Collins. "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.”
After brushing with BioMin Restore Plus, the active ingredient adheres to the tooth surface, where these microscopic particles slowly dissolve over an eight to 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."
It is this controlled release mechanism, continuing to deposit mineral on the tooth surface over several hours which 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 David Gillam explained, “There are many causes of dentine hypersensitivity which means that previously no single toothpaste works 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 per cent 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.
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.
Dr.Collins BioMin Restore and Restore Plus toothpastes are directly available at https://biomintoothpaste.com