Clinical Trials

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.

* https://www.abc.net.au/news/2019-03-19/john-barnes-ex-afl-ruckman-joins-planned-concussion-class-action/10915086

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
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