Eastman Dental Institute first in Europe to trial treatment for painful inflammatory mouth disorder

The Eastman Dental Insitute is the first in Europe to trial a treatment for a painful inflammatory mouth disorder.

Oral lichen planus is a chronic inflammatory condition that affects the mucous membranes inside the mouth.  The condition is an autoimmune disorder, which occurs when the body’s immune system attacks its own cells.

As well as displaying ‘lacy’ white patches, oral lichen planus can make the mouth red and inflamed, with open sores that cause a painful burning sensation; making speaking, chewing and swallowing, at times, agonizing.

Symptoms can be managed, but people who have oral lichen planus need regular monitoring as they may be at increased risk of developing mouth cancer.

The causes of lichen planus are currently unknown but research into treatments could bring new hope to sufferers. Researchers at Eastman Dental Institute and Hospital, part of University College London (UCL) and University College London Hospitals Trust (UCLH), have recently opened a new study investigating the use of patches that are engineered to stick to the wet lining of the mouth and deliver corticosteroid hormones, so to reduce inflammation and provide relief.

The study is being run at over 20 sites around the world and this month, the Eastman Dental Institute/Hospital became the first in Europe to recruit a patient to the trial.

Stefano Fedele, Professor of Oral Medicine at University College London and an Honorary Consultant at University College London Hospitals, is leading the study at the Eastman Dental Institute/Hospital. He spoke to us to explain more about the trial, what it means for sufferers and the importance of research into dental and oral disease. He told us:

“Oral and Dental research is a often perceived as a small field if one compares it to other specialities; but it deals with disorders that are common, often chronic, and can notably affect the quality of life of the affected individuals.

Current data suggest that nearly half of the world population, that’s 3.5 billion people, suffer disability from oral diseases. The NHS bill for Oral and Dental disorders is also significant, with the NHS in England spending around £3.4 billion a year”

Speaking about the trial he explained;

“This is a phase II trial of a novel drug delivery system produced by AFYX Therapeutics (formerly known as Dermtreat), consisting of a biodegradable adhesive patch (Rivelin®) which is designed to deliver a potent well-known corticosteroid to the mucosal surface. The current standard care consists of off-label use of dermatological creams and ointments or nasal sprays, which don’t allow precise control of medication dosage and are not easy to apply.

This is an important area of unmet need for patients, as there is currently no licensed treatment for oral lichen planus. If successful, the study will be followed by a phase III trial designed to demonstrate how effective the patches can be. 

If successful, the Rivelin® patch delivery system has the potential to revolutionise the treatment of this common and painful disorder.”

Professor Fedele is also the Lead for Oral and Dental Research at NIHR Clinical Research Network (CRN) North Thames and notes how the NIHR play a major part in many of the trials designed to research oral disease.

“The CRN was instrumental in facilitating the set-up of this study at our site. We are also very fortunate to benefit from a dedicated Clinical Research Facility (The Eastman Clinical Investigation Centre - ECIC), which is a joint collaboration between UCL Eastman Dental Institute and UCLH Eastman Dental Hospital and is supported by funding from NIHR CRN and the NIHR UCLH Biomedical Research Centre.”

However, such research could never happen without active patient involvement, for which Professor Fedele is particularly grateful:

“Oral Lichen Planus is a relatively common disorder and there are several hundreds of affected individuals attending our Oral Medicine clinic at the UCLH Eastman Dental Hospital every year. Aside from the clinical academics directly involved in the study, we are grateful to the other Oral Medicine consultants and clinicians who are supporting the study and help identify suitable patients.

Above all, we are of course indebted to our patients and in particular our first recruit.  Without patient involvement these trials could not be run in the NHS.”

Oral and dental disorders continue to trouble many of the UK population. Oro-pharyngeal cancer alone has increased by 24% over the last decade.  Research into treatments and cures remains vital, and in an added message to patients Professor Fedele says:

“I would encourage all patients with oral and dental disease to consider participating in clinical trials. There is now convincing evidence that patient outcomes are better in research-focused hospitals, and indeed study participants might benefit from receiving the newest treatment and experience additional care and attention from the clinical trial staff.

Study participants have a unique opportunity to contribute to medical advances and help find new ways to prevent, diagnose, or treat oral diseases.”