New treatment for aphthous ulcers developed

Dental Tribune International

Fri. 7 June 2024

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UMEÅ, Sweden: Recurrent aphthous stomatitis (RAS) is the most common painful oral mucosal disease in the world, occurring in 5%–25% of the world’s population. Swedish start-up Mucocort is among the vanguard of companies working to develop an effective treatment for RAS and has created an intra-oral patch that promises to significantly reduce pain and expedite healing. It recently received approval from the Swedish Medical Products Agency and the Swedish Ethical Review Authority to commence a clinical trial in August.

Wide range of predisposing factors

The aetiology and pathogenesis of RAS are not well known. It is considered to be a multifactorial condition, and a wide range of triggers have been reported, including local injury, bacterial and viral factors, stress, food allergies, vitamin and micronutrient deficiencies, immunologic factors, underlying systemic disease, hormonal factors and medication.

Given the widespread and painful nature of RAS, it is unsurprising that many diverse treatments have been developed. However, despite these efforts, clinical trials to date have yielded very little success, and there remains no curative treatment available for the condition, other than avoiding definitive patient-specific triggers. This creates an urgent need for new and more effective treatment strategies.

What is the Mucocort patch, and how does it work?

Speaking to Dental Tribune International, Jean Lycke, Mucocort’s project manager, explained that, after being applied to the lesion, “the patch absorbs up to 100% of the ‘inflammatory soup’ of tissue fluid, inflammatory compounds, viruses and bacteria in the aphthous ulcer”. The patch is able to absorb 20–25 times its own weight and becomes a gel within 3–4 hours. It can then be swallowed or spat out, and it is fully biodegradable.

According to co-developer Dr Mats Jontell, professor emeritus of oral medicine and pathology at the University of Gothenburg in Sweden, “The patch primarily provides immediate pain relief. We believe the effective pain relief provided by this new treatment will, among other things, drastically reduce the need for cortisone treatment that is currently used to relieve the discomfort.” The patch inhibits inflammation and accelerates the natural healing process by shielding and drying the ulcer through a hygroscopic effect.

Clinical trial to start soon

Having received the approval of the Swedish regulatory authorities, Mucocort is now set to commence a clinical trial of the patch in August, and the trial is expected to last approximately six months. The primary end point is pain relief, and the study will also assess patients’ quality of life regarding their RAS.

The clinical trial will be conducted in collaboration with Oral Care, an established Swedish private dental clinic chain also focused on research. Production of the patch will be managed by Mucocort’s strategic partner, Aurena Laboratories in Sweden.