Toothpaste Gets FDA Approval to Relieve Sensitivity

Richard Gawel
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Dr. Collins’ BioMin Restore Plus toothpaste has received 510K approval from the Food and Drug Administration (FDA) for sensitivity relief. According to the company, it is the first toothpaste with bioactive glass that includes fluoride to be approved by the FDA for sale in the United States.

BioMin Restore Plus 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, Dr. Collins said.

Available only by prescription from registered dental clinicians, BioMin Restore Plus is based on BioMin F, a patented bioactive glass complex developed by Queen Mary University of London by professor Robert Hill and his team of material scientists. Dr. Collins expects the toothpaste to be available in the United States in the spring of 2021.

After brushing with BioMin Restore Plus, the active ingredient adheres to the tooth surface, where these microscopic particles slowly dissolve over an 8- to 12-hour period, constantly releasing calcium, phosphate, and fluoride ions.

These materials combine to deposit fluorapatite, similar to tooth enamel but more acid-resistant, forming a protective coating on 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 minerals on the tooth surface over several hours, helps BioMin Restore Plus to be more effective at relieving sensitivity than conventional toothpastes, which are rinsed away in around an hour, Dr. Collins said.

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, Dr. Collins said.

“There are many causes of dentine hypersensitivity, which means that previously no single toothpaste worked for everyone,” said BioMin clinical consultant Dr. David Gillam.

“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,” Gillam said.

Studies from around the world also confirm that the fluorapatite developed from BioMin F penetrates deeply inside exposed dentine tubules, Dr. Collins said.

In a recent poll by Dr. Collins, dental clinicians reported that dentine hypersensitivity affects well over 40% of the population, most prevalently between the ages of 20 and 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 clinicians polled felt unsatisfied with their treatment of such cases.

“I am delighted to see that the fluoride version of BioMin toothpaste is finally becoming available for US clinicians to prescribe for their patients,” said Theresa McCarter, a dental hygienist and dental health educator.

“I feel it is an excellent everyday toothpaste which will benefit 80% to 90% of my patients. I am sure this product will become a real gamechanger,” McCarter said.

“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,” said Dr. Colin Suzman, dentist and founder of Dr. Collins.

“We believe this groundbreaking 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,” Suzman said.

BioMin Restore Plus has a fresh mint taste and leaves the mouth feeling clean and healthy, Dr. Collins said. BioMin Restore toothpaste is also available, based on a calcium/phosphate bioglass, for those who prefer a fluoride-free alternative.

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