Impression Healthcare’s (ASX: IHL) “world first” clinical trial using its cannabidiol (CBD)-based mouthwash and toothpaste to treat gingivitis and periodontitis (gum disease) has now been registered with Australian and New Zealand Clinical Trial Registry.
With patient recruitment now scheduled for August, Impression will carry out a phase 2a randomised controlled clinical trial to evaluate the clinical safety and efficacy of its CBD-based mouthwash and toothpaste on 40 people suffering from gingivitis and gum disease.
Trial participants will use the toothpaste and mouthwash three times a day over 30 days and will then be monitored from gum inflammation and overall gum health.
US-based AXIM Biotechnologies will manufacture the CBD formulation for the trial under an agreement announced earlier this month.
“Formal registration of the gingivitis and periodontitis trial represents significant progress in Impression’s medicinal cannabis activities and is the culmination of many months of work by our team and research partners,” Impression chief executive officer Joel Latham said.
“We are excited to have assembled highly qualified researchers for a world first trial for the use of CBD in treatment of gingivitis and gum disease, which are major problems representing a major market.”
Mr Latham added he was confident the trial will produce peer-reviewed data for sales of the company’s unique products via Australia’s special access scheme, in addition to developing further commercialisation opportunities for products in the space.
According to Impression, about 20% of the Australian population suffers from moderate to severe gum disease – equating to 5 million people.
In the over 55 age demographic, the amount of gum disease sufferers is estimated at 40%.
Impression’s share of the trial costs is capped at $80,000 with Swinburne University of Technology and Australia’s largest medicinal cannabis product distributor Cannvalate to contribute the remaining funds.
This trial will be the first of Impression’s four clinical trials planned for this year evaluating medicinal cannabis products.
“The trials and subsequent commercial sales represent an exciting new potential avenue for the company to generate sales in one of the fastest growing emerging sectors in the world,” Mr Latham said.
Prior to market open, Impression’s share price was $0.036.