Impression Healthcare undertaking four clinical trials in 2019 for the creation of four distinct products with clinical evidence.
Clinical Trial – Gum Disease
Gum Disease affects up to 5M people in Australia
- Cannabidiol (CBD) is known to be a potent suppressor of inflammatory processes by inhibiting the expression of cytokines and this can cause reduced bone resorption and can reduce the rate of bone loss coincident with periodontitis
- A trial to examine the benefits of Cannabidiol (CBD) Mouthwash and Toothpaste to reduce the grading of Periodontitis compared to a placebo
- Severe (Grade 4) Periodontitis can lead to tooth loss, bone damage and is a risk factor for heart and lung disease
- AXIM Biotechnologies Incorporated will provide the products for the clinical trials and also facilitate commercial sales under a royalty arrangement, subject to initial clinical success
Clinical Trial – Sleep Apnoea
About 1M people in Australia have symptomatic Obstructive Sleep Apnoea
- A trial to examine the benefits of a Dronabinol variant for severe Obstructive Sleep Apnoea Syndrome (OSAS) compared to a placebo.
- A recent study by Carley et al* demonstrated an improvement in the Apnoea-Hypopnea Index (AHI) Scoring by over 30% in patients given nocturnal dronabinol
- Impression is developing its own unique formulation in conjunction with Swinburne University to potentially enhance results
- Participants identified as having severe OSAS (AHI >40) will be treated with a nocturnal Dronabinol variant will have their AHI periodically re-measured
- Sleep Apnoea is under-treated due to CPAP machine “non-compliance”. Treatment with a simple pill is considered highly desirable
- Comparable companies involved in Sleep Apnoea product development and manufacture include Resmed, Somnomed and Oventus.
Clinical Trial – Concussion
Former AFL Player John Barnes is leading a planned class action against the AFL regarding its treatment of concussion during the game*
- CBD is known to be a neuroprotective agent and prevents secondary neurological damage after concussion and traumatic brain Injury (TBI) through a variety of anti-inflammatory mechanisms
- The World Anti-Doping Authority (WADA) and the Australian Sports Anti-Doping Authority (ASADA) have recently confirmed that THC-Free (Synthetic) CBD is not illegal for consumption by sportspeople
- Participants identified as having had a head injury or concussion during an AFL or NRL football match will be commenced on twice-daily CBD oil and undertake brain MRIs and cognitive scoring during the treatment program
- Concussion in sport has been well-publicised with long-term neurologically problems in high profile individuals being attributed to concussions received in professional sports.
- This will be a unique study and one of the first of its kind expected to generate significant interest.
Clinical Trial – TMJ Dysfunction
Temporomandibular Joint Dysfunction is a common problem with poor treatment options
- CBD is a potent suppressor of inflammatory processes but is also recognised to reduce muscular spasm, joint spasticity, TMJ joint pain and anxiety related bruxism symptoms
- A trial to examine the benefits of CBD oil for reducing the severity of Temporomandibular Joint Dysfunction (TMJ), as compared to placebo
- Severe TMJ Disorder is highly detrimental to patient quality of life, because the symptoms can be chronic and difficult to manage
- Participants identified as having severe TMJ (Grade 3) will be commenced on twice-daily CBD oil and have their TMJ grading re-measured weekly